http://www.pharmtech.com/pharmtech/Manufacturing/Article/list/40939 Equipment and processing in pharma, biopharma, specialty & generic drug manufacturing. Aseptic processing, cytotoxic manufacturing, small & large molecules. 2013-05-18T13:33:18Z http://www.pharmtech.com/pharmtech/Production+Lines/Experts-at-INTERPHEX-Discuss-Quality-by-Design/ArticleStandard/Article/detail/812819?contextCategoryId=40939&ref=25 Making the effort to apply new methods to pharmaceutical processing will bring benefits. 2013-05-15T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192013/812819null HTML http://www.pharmtech.com/pharmtech/Whitepapers/Humidity-Measurement-in-Cleanrooms-The-Devil-is-in/ArticleStandard/Article/detail/811593?contextCategoryId=40939&ref=25 Vaisala makes the world's finest humidity sensors and in this article, we describe several observations on humidity measurement in controlled environments. We hope this information will help you clarify your approach to controlling and monitoring this hard-to-measure parameter. 2013-04-25T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172013/811593null REMOTE http://www.pharmtech.com/pharmtech/Production+Lines/Evaluating-Equipment-Utility-and-Innovation/ArticleStandard/Article/detail/810404?contextCategoryId=40939&ref=25 Pharmaceutical Technology's survey of manufacturing equipment and trends shows satisfaction with utility and innovation in most solid-dosage and parenteral drug-manufacturing equipment. 2013-04-17T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/152013/810404null HTML http://www.pharmtech.com/pharmtech/Manufacturing/Implementing-Disposable-Cleanroom-Apparel-into-the/ArticleStandard/Article/detail/766654?contextCategoryId=40939&ref=25 This paper addresses the benefits of disposable cleanroom apparel versus reusable apparel. It explains how disposable cleanroom apparel can help play a role in helping pharmaceutical manufacturers reduce their waste stream while reducing the risk of contamination. 2013-02-27T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/132012/766654null REMOTE http://www.pharmtech.com/pharmtech/Troubleshooting/Experts-Give-Sneak-Peeks-into-INTERPHEX-2013-Confe/ArticleStandard/Article/detail/810410?contextCategoryId=40939&ref=25 Speakers discuss modularization, single-use systems, and process validation in a series of podcasts available on the Pharmaceutical Technology website. 2013-04-17T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/152013/810410null HTML http://www.pharmtech.com/pharmtech/Troubleshooting/Measuring-Tablet-Hardness-A-Primer/ArticleStandard/Article/detail/812820?contextCategoryId=40939&ref=25 Crushing, fracturing, and bending tests quantify hardness. 2013-05-15T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192013/812820null HTML http://www.pharmtech.com/pharmtech/Ingredients+Insider/Intellectual-Property-Battles-in-Solid-State-Chemi/ArticleStandard/Article/detail/813405?contextCategoryId=40939&ref=25 The rejection by India's Supreme Court on Novartis' Glivec/Gleevec (imatinib mesylate) and other recent case law raise important issues on patent strategies for solid forms. 2013-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813405/pt0513_api_thumb_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813405null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Lyophilization-A-Primer/ArticleStandard/Article/detail/813407?contextCategoryId=40939&ref=25 Optimized freeze-drying cycles can offer scientific and business advantages. 2013-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813407/0513_primer_thumb_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813407null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Facility-Trends-Modularization-and-Single-Use/ArticleStandard/Article/detail/813398?contextCategoryId=40939&ref=25 Pharmaceutical Technology spoke with INTERPHEX 2013 conference-session presenters to gain insight on trends in facility and process design. 2013-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813398null XML http://www.pharmtech.com/pharmtech/Industry+Leaders/QampA-with-Stuart-E-Needleman-Aptuit/ArticleStandard/Article/detail/813406?contextCategoryId=40939&ref=25 A Q&A with Stuart E. Needleman, President and Chief Operating Officer of Aptuit, on recent industry trends. 2013-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813406/needleman_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813406null XML http://www.pharmtech.com/pharmtech/Ingredients/Using-Thermal-Ink-Jet-Printing-Technology-to-Produ/ArticleStandard/Article/detail/813397?contextCategoryId=40939&ref=25 Cocrystals are used to improve the performance of APIs that have non-ideal physiochemical properties by cocrystallizing the API with a second compound that modulates the API to provide a way to improve a drug's bioavailability, stability, and processability. 2013-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813397null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Understanding-ICH-Q11mdashFDAs-Guidance-on-the-Dev/ArticleStandard/Article/detail/813396?contextCategoryId=40939&ref=25 The author provides a review of FDA's guidance document, Guidance for Industry: Q11 Development and Manufacture of Drug Substances, and its relation to the International Conference on Harmonization's Q11 document and its application to the industry. 2013-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813396null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Co-Opetition-in-Drug-Development/ArticleStandard/Article/detail/813391?contextCategoryId=40939&ref=25 The author suggests co-opetition as a future model for collaboration in drug development. 2013-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813391null XML http://www.pharmtech.com/pharmtech/Ingredients/Academic-and-Public-Partnerships-in-Solid-State-Ch/ArticleStandard/Article/detail/813400?contextCategoryId=40939&ref=25 Solid-state chemistry is an important part of drug development, and public research is advancing the field. 2013-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813400null XML http://www.pharmtech.com/pharmtech/Troubleshooting/Using-a-Gravimetric-Feeder-to-Dose-Pharmaceutical-/ArticleStandard/Article/detail/813395?contextCategoryId=40939&ref=25 Loss-in-weight feeders provide high accuracy for batch or continuous processes. 2013-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813395null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Controlling-Ice-Nucleation-During-the-Freezing-Ste/ArticleStandard/Article/detail/813411?contextCategoryId=40939&ref=25 Lyophilization technologies for controlled nucleation. 2013-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813411/pt0513_cvs_thumb_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813411null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Prefilled-Syringes-or-Peptide-Pills/ArticleStandard/Article/detail/813404?contextCategoryId=40939&ref=25 The impact of new delivery technologies in designing peptide therapies. 2013-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813404/pt0513_pharm_thumb_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813404null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Big-Pharmas-Manufacturing-Investments-in-Biologics/ArticleStandard/Article/detail/812582?contextCategoryId=40939&ref=25 Despite overall manufacturing rationalization in the pharmaceutical/biopharmaceutical industry, the large pharmaceutical companies continue to invest in biologic-based manufacturing. The author provides an update in recent investment activity among the pharmaceutical majors in biologic-drug substance, vaccine, and parenteral drug manufacturing. 2013-05-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192013/812582/pst0513_bio_t_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192013/812582null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Applying-Continuous-Flow-Pasteurization-and-Steril/ArticleStandard/Article/detail/812590?contextCategoryId=40939&ref=25 High-temperature, short-time (HTST) pasteurization and ultra-high temperature (UHT) sterilization are potentially useful as part of the trend toward methods of continuous manufacturing of bio/pharmaceuticals. 2013-05-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192013/812590null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Ensuring-Sterility-of-Parenteral-Products/ArticleStandard/Article/detail/811746?contextCategoryId=40939&ref=25 Experts describe best practices for sterility assurance in parenteral drug manufacturing. This article contains bonus online-exclusive material. 2013-04-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182013/811746/pt0413_sterility_t_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182013/811746null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Evaluating-Equipment-Utility-and-Innovation/ArticleStandard/Article/detail/811750?contextCategoryId=40939&ref=25 A Pharmaceutical Technology survey shows satisfaction with utility and innovation in most solid dosage and parenteral drug-manufacturing equipment. 2013-04-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182013/811750/pt0413_equip_t_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182013/811750null XML http://www.pharmtech.com/pharmtech/Troubleshooting/Using-a-Gravimetric-Feeder-for-Dosing-Pharmaceutic/ArticleStandard/Article/detail/808135?contextCategoryId=40939&ref=25 Loss-in-weight feeders provide high accuracy for feeding powders. 2013-03-20T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/112013/808135null HTML http://www.pharmtech.com/pharmtech/Production+Lines/Incorporating-Process-Analytical-Technology-Data-i/ArticleStandard/Article/detail/808119?contextCategoryId=40939&ref=25 Process analytical technology (PAT) is being successfully used to improve understanding and optimize pharmaceutical unit operations, but greater value can be obtained by integrating PAT with overall process control of a continuous manufacturing system. Pharmaceutical Technology spoke with Ivo Backx, manager of business and project development for the pharmaceutical industry at Siemens Industry Automation Division, to gain insight on the issues involved. 2013-03-20T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/112013/808119null HTML http://www.pharmtech.com/pharmtech/Feature+Articles/Sterilizing-with-Nitrogen-Dioxide/ArticleStandard/Article/detail/809033?contextCategoryId=40939&ref=25 Room-temperature sterilization using nitrogen dioxide gas benefits parenteral drugs. 2013-03-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/142013/809033null XML http://www.pharmtech.com/pharmtech/Article/Foam-Granulation/ArticleStandard/Article/detail/809036?contextCategoryId=40939&ref=25 The authors review developments in wet granulation using a twin-screw extruder. 2013-03-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/142013/809036/opening-graphic_web_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/142013/809036null XML http://www.pharmtech.com/pharmtech/Article/Advances-in-PAT-for-Parenteral-Drug-Manufacturing/ArticleStandard/Article/detail/809030?contextCategoryId=40939&ref=25 Applying quality-by-design and process analytical technology facilitates process understanding and control of various operations in lyophilization. 2013-03-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/142013/809030/PT0313_Cover-2_r_web_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/142013/809030null XML http://www.pharmtech.com/pharmtech/Ingredients/Adhering-to-ICH-Q7-for-GMPs/ArticleStandard/Article/detail/809039?contextCategoryId=40939&ref=25 FDA's requirements for API manufacturers in regards to ICH Q7. 2013-03-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/142013/809039null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Isolation-of-Pharmaceutical-Impurities-and-Degrada/ArticleStandard/Article/detail/809035?contextCategoryId=40939&ref=25 The authors demonstrate that using supercritical fluid chromatography offers distinct advantages in speed and in clean isolation of the desired peaks. 2013-03-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/142013/809035null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Tackling-Common-Problems-in-Tableting-and-Tooling/ArticleStandard/Article/detail/809044?contextCategoryId=40939&ref=25 The tableting science anti-research (TSAR) project seeks to understand why certain formulations stick to tablet tooling. 2013-03-01T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/142013/809044null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Concerns-and-Innovations-in-Tablet-Splitting-and-S/ArticleStandard/Article/detail/809046?contextCategoryId=40939&ref=25 A roundtable discussion of the challenges and innovations in tablet splitting featuring Freeman Technology, Accu-Break Pharmaceuticals, and Medelpharm. 2013-03-01T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/142013/809046/200373068-001_web_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/142013/809046null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Continuous-Improvement-in-Tablet-Coating-and-Dry-G/ArticleStandard/Article/detail/809042?contextCategoryId=40939&ref=25 Recent advances in equipment design and operation in spraying, drying, and mixing can improve the tablet-coating process. 2013-03-01T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/142013/809042/BRC_100_web_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/142013/809042null XML http://www.pharmtech.com/pharmtech/Troubleshooting/Energy-Management-in-Biopharmaceutical-Facilities/ArticleStandard/Article/detail/805487?contextCategoryId=40939&ref=25 A Q&A with Michael Lacey, plant manager at the National Institute for Bioprocessing Research and Training. 2013-02-20T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/072013/805487null HTML http://www.pharmtech.com/pharmtech/Production+Lines/University-Research-Centers-Transfer-Continuous-Ma/ArticleStandard/Article/detail/805483?contextCategoryId=40939&ref=25 Engineering groups at Rutgers and MIT constructed solid-dosage continuous manufacturing lines and transferred the technology to pharmaceutical industry partners. 2013-02-20T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/072013/805483null HTML http://www.pharmtech.com/pharmtech/Manufacturing/Rouge-Contaminants-and-Water-Systems/ArticleStandard/Article/detail/804847?contextCategoryId=40939&ref=25 Measuring the rouge corrosion rate can help determine when a system should be cleaned so the final product is not impacted 2013-02-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/062013/804847null XML http://www.pharmtech.com/pharmtech/Manufacturing/Navigating-Emerging-Markets-mdash-Eastern-Europe/ArticleStandard/Article/detail/804863?contextCategoryId=40939&ref=25 Eastern Europe is moving towards a goal of harmonized regulations. 2013-02-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/062013/804863/easterneurope_thumbnail.gif http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/062013/804863null XML http://www.pharmtech.com/pharmtech/Manufacturing/Report-from-India/ArticleStandard/Article/detail/804852?contextCategoryId=40939&ref=25 Quality assurance of biological products is central to India's good distribution practices guidelines. 2013-02-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/062013/804852/india_thumbnail.gif http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/062013/804852null XML http://www.pharmtech.com/pharmtech/Insider+Solutions/The-Human-Error-Behind-Human-Error/ArticleStandard/Article/detail/804848?contextCategoryId=40939&ref=25 A thorough investigation of all possible causes of deviations should be performed. 2013-02-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/062013/804848null XML http://www.pharmtech.com/pharmtech/Peer-Reviewed+Research/Determination-of-Surface-Visible-Residue-Limits-on/ArticleStandard/Article/detail/804857?contextCategoryId=40939&ref=25 The minimum amount of residue that can be visually detected is demonstrated for a small number of active pharmaceutical ingredients (APIs) on a range of different surface materials. 2013-02-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/062013/804857/residue_thumbnail.gif http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/062013/804857null XML http://www.pharmtech.com/pharmtech/Standards+%26+Regulation/Modernization-of-the-Standards-for-Elemental-Impur/ArticleStandard/Article/detail/804849?contextCategoryId=40939&ref=25 Recent activity in standards-setting organizations has raised interest in the impact of testing for impurities that may enter the product before it is mined or harvested or even due to intentional use of some reagents. 2013-02-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/062013/804849/cogs2_thumbnail.gif http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/062013/804849null XML http://www.pharmtech.com/pharmtech/Manufacturing/Seeking-Cold-Chain-Efficiency/ArticleStandard/Article/detail/804846?contextCategoryId=40939&ref=25 Medication safety and efficacy depend on maintaining products at the proper temperature. 2013-02-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/062013/804846/coldchain_thumbnail.gif http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/062013/804846null XML http://www.pharmtech.com/pharmtech/Manufacturing/Solving-Tableting-and-Tooling-Problems/ArticleStandard/Article/detail/804858?contextCategoryId=40939&ref=25 Adopting a seven-step process to maintenance and storage improves tableting quality. 2013-02-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/062013/804858/troubleshooting_thumbnail.gif http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/062013/804858null XML http://www.pharmtech.com/pharmtech/Manufacturing/Pharma-Fights-Healthcare-Cost-Containment-Policies/ArticleStandard/Article/detail/804210?contextCategoryId=40939&ref=25 The ongoing economic crisis in Europe has accelerated healthcare cost-containment measures targeting the price of pharmaceuticals, but the pharma industry is not giving in without a fight. 2013-02-01T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052013/804210/Magnifying_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052013/804210null XML http://www.pharmtech.com/pharmtech/Production+Lines/Using-Micronization-to-Reduce-API-Particle-Size/ArticleStandard/Article/detail/802227?contextCategoryId=40939&ref=25 Micronization can be performed with a jet mill or bead mill. 2013-01-16T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/022013/802227null HTML http://www.pharmtech.com/pharmtech/Troubleshooting/Improving-Tablet-Press-Tooling-Maintenance-and-Sto/ArticleStandard/Article/detail/802228?contextCategoryId=40939&ref=25 Adopting a seven-step process resolves tableting problems. 2013-01-16T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/022013/802228null HTML http://www.pharmtech.com/pharmtech/BioForum/The-Transformation-to-Process-Centered-Organizatio/ArticleStandard/Article/detail/803563?contextCategoryId=40939&ref=25 Is process-centered organization in biopharmaceutical manufacturing a stepping stone or a stumbling block? 2013-01-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/042013/803563null XML http://www.pharmtech.com/pharmtech/Feature+Articles/A-Look-Ahead-at-Manufacturing-and-Regulation/ArticleStandard/Article/detail/803572?contextCategoryId=40939&ref=25 FDA talks about the changing scope of regulatory science and its effect on drug reviews, site inspections, and overall approaches. 2013-01-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/042013/803572/lightbulb_thumbnail.gif http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/042013/803572null XML http://www.pharmtech.com/pharmtech/Ingredients+Insider/Strategies-in-API-Scale-Up/ArticleStandard/Article/detail/803566?contextCategoryId=40939&ref=25 Process chemists employ a variety of approaches to improve yield, purity, and stereoselectivity. 2013-01-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/042013/803566/Molecules_colour_thumbnail.gif http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/042013/803566null XML http://www.pharmtech.com/pharmtech/Standards+%26+Regulation/Tablet-Splitting-A-New-Focus-for-Regulators/ArticleStandard/Article/detail/800441?contextCategoryId=40939&ref=25 Tablet splitting is a new area of focus for regulators. The FDA tells PTE more about the challenges in this area. 2013-01-01T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/512012/800441/Purple_Tablets_thumbnail.gif http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/512012/800441null XML http://www.pharmtech.com/pharmtech/Manufacturing/The-Challenge-for-Manufacturers-in-Tablet-Splittin/ArticleStandard/Article/detail/800850?contextCategoryId=40939&ref=25 Dr. Charles Kettler, director of Natoli Scientific, looks at the challenges that tablet scoring poses to tablet manufacturers. 2013-01-01T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/512012/800850null XML http://www.pharmtech.com/pharmtech/Manufacturing/Aseptic-Processing-A-Primer/ArticleStandard/Article/detail/800840?contextCategoryId=40939&ref=25 PharmTech speaks to Ray O'Connor from the National Institute for Bioprocessing Research and Training (NIBRT) for an overview of aseptic processing. 2013-01-01T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/512012/800840/Vaccines_thumbnail.gif http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/512012/800840null XML http://www.pharmtech.com/pharmtech/Manufacturing/Drug-Quality-at-Center-Stage-for-FDA-and-Manufactu/ArticleStandard/Article/detail/800843?contextCategoryId=40939&ref=25 Shortages and compounding disaster spur efforts to overhaul manufacturing oversight and stimulate industry improvements. 2013-01-01T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/512012/800843/Pink_Tablets_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/512012/800843null XML http://www.pharmtech.com/pharmtech/Manufacturing/Report-from-Brazil/ArticleStandard/Article/detail/800847?contextCategoryId=40939&ref=25 The health ministry of Brazil recently signed an agreement to obtain its production technology to locally develop the antiretroviral drug atazavanir sulfate. 2013-01-01T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/512012/800847/Brazil01_thumbnail.gif http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/512012/800847null XML http://www.pharmtech.com/pharmtech/Standards+%26+Regulation/EMA-and-FDA-on-Process-Validation/ArticleStandard/Article/detail/800849?contextCategoryId=40939&ref=25 Siegfried Schmitt, a principal consultant with PAREXEL, discusses the EMA's guideline on process validation and how it compares with FDA's process validaton guidance. 2013-01-01T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/512012/800849/Checkbox_thumbnail.gif http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/512012/800849null XML http://www.pharmtech.com/pharmtech/Manufacturing/Manufacturing-Misery-in-Vaccines/ArticleStandard/Article/detail/800848?contextCategoryId=40939&ref=25 Vaccine manufacturing was predicted in 2008 to be on the cusp of a golden era, but instead the industry has experienced cost pressures, high-profile liability cases and production setbacks. 2013-01-01T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/512012/800848/Magnifying_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/512012/800848null XML http://www.pharmtech.com/pharmtech/Peer-Reviewed+Research/X-ray-Powder-Diffraction-Pattern-Indexing-for-Phar/ArticleStandard/Article/detail/800851?contextCategoryId=40939&ref=25 The authors discuss the valuable information that can be obtained from indexing and its applications in routine screening and analysis of solid forms. 2013-01-01T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/512012/800851/lattice_thumbnail.gif http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/512012/800851null XML http://www.pharmtech.com/pharmtech/Analytics/Tablet-Splitting-and-Analytical-Technologies/ArticleStandard/Article/detail/800616?contextCategoryId=40939&ref=25 Tim Freeman of Freeman Technology explains how new analytical technologies have influenced quality criteria and standards for the uniformity of dosage units, and why more accurate systems are leading to greater focus on tablet scoring. 2013-01-01T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/512012/800616null XML http://www.pharmtech.com/pharmtech/Standards+%26+Regulation/A-Look-Ahead-at-Manufacturing-and-Regulation/ArticleStandard/Article/detail/800845?contextCategoryId=40939&ref=25 FDA talks about the changing scope of regulatory science and its effect on drug reviews, site inspections, overall approaches. 2013-01-01T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/512012/800845/EULightbulb_thumbnail.gif http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/512012/800845null XML http://www.pharmtech.com/pharmtech/Online+Only/Tablet-Splitting-Concerns/ArticleStandard/Article/detail/800623?contextCategoryId=40939&ref=25 When splitting unscored tablets, the main concerns relate to API dosage control and the potential modification of time-release characteristics. PTE speaks with tableting experts Thierry Menard, Lab Manager, And Bruno Villa, President, both at Medelpharm, about how manufacturers are approaching the challenges. 2013-01-01T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/512012/800623null XML http://www.pharmtech.com/pharmtech/Production+Lines/Plastic-Shows-Benefits-in-Parenteral-Packaging/ArticleStandard/Article/detail/800034?contextCategoryId=40939&ref=25 Plastic is finding increased use in vials and syringes as concerns about glass breakage and delamination and desire for increased functionality lead pharmaceutical companies to consider alternatives. 2012-12-19T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/502012/800034null HTML http://www.pharmtech.com/pharmtech/In+the+Mixer/Sterilizing-Parenteral-Drug-Containers-with-Nitrog/ArticleStandard/Article/detail/800035?contextCategoryId=40939&ref=25 Room-temperature sterilization using nitrogen dioxide gas provides benefits for sterilizing the external surfaces of single-dose, parenteral drug containers. 2012-12-19T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/502012/800035null HTML http://www.pharmtech.com/pharmtech/News/Ranbaxy-Issues-Voluntary-Recall-of-Atorvastatin-Du/ArticleStandard/Article/detail/798683?contextCategoryId=40939&ref=25 The company issues voluntary recall of certain lots due to possible contamination with small glass particles. 2012-12-04T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/492012/798683null HTML http://www.pharmtech.com/pharmtech/Troubleshooting/A-Lifecycle-Approach-to-Optimizing-Cleaning-System/ArticleStandard/Article/detail/799123?contextCategoryId=40939&ref=25 Clean-in-place systems should be optimized during design and commissioning and after validation. 2012-12-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/492012/799123/troubleshooting_thumbnail.gif http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/492012/799123null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Patents-and-Postapproval-Batch-Testing/ArticleStandard/Article/detail/799111?contextCategoryId=40939&ref=25 Can postapproval FDA filings immunize pharma companies from patent lawsuits? 2012-12-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/492012/799111/Legal_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/492012/799111null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Job-Security/ArticleStandard/Article/detail/799119?contextCategoryId=40939&ref=25 Annual employment survey results show greater confidence in the pharma industry. 2012-12-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/492012/799119null XML http://www.pharmtech.com/pharmtech/Agent-in-Place/Mice-on-a-Mission/ArticleStandard/Article/detail/799112?contextCategoryId=40939&ref=25 To ensure the accuracy of scientific testing, protect the subjects to avoid data contamination. 2012-12-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/492012/799112null XML http://www.pharmtech.com/pharmtech/In+the+Field/Report-from-South-Korea/ArticleStandard/Article/detail/799121?contextCategoryId=40939&ref=25 Domestic companies are changing their business models in response to recent drug price cuts. 2012-12-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/492012/799121/korea_thumbnail.gif http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/492012/799121null XML http://www.pharmtech.com/pharmtech/Online+Only/Harmonizing-Global-Efforts-Against-Counterfeits/ArticleStandard/Article/detail/798058?contextCategoryId=40939&ref=25 In addition to globalisation, high financial rewards and low penalties for counterfeiters are contributing to the rise in fake medicines. 2012-12-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/482012/798058null XML http://www.pharmtech.com/pharmtech/Statistical+Solutions/Time-to-Revise-ICH-Q9/ArticleStandard/Article/detail/799120?contextCategoryId=40939&ref=25 A change in terminology could emphasize patient protection. 2012-12-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/492012/799120null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Pharma-Innovation/ArticleStandard/Article/detail/799118?contextCategoryId=40939&ref=25 A look at the year's leaders in innovation strategy, including the top bio/pharmaceutical companies and award recipients from AAPS, PhRMA, and CPhI. 2012-12-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/492012/799118/lightbulb_thumbnail.gif http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/492012/799118null XML http://www.pharmtech.com/pharmtech/Manufacturing/Collaborating-to-Protect-the-Supply-Chain-from-Cou/ArticleStandard/Article/detail/799125?contextCategoryId=40939&ref=25 Adeline Siew PharmTech speaks to Lynne Byers and Brian Johnson about Rx-360's initiatives to protect patient safety. 2012-12-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/492012/799125/counterfeiting_thumbnail.gif http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/492012/799125null XML http://www.pharmtech.com/pharmtech/Production+Lines/Protecting-the-Public-Anticounterfeiting/ArticleStandard/Article/detail/796776?contextCategoryId=40939&ref=25 Overt and covert packaging technologies have evolved to authenticate drugs and fight counterfeits. 2012-11-21T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/462012/796776null HTML http://www.pharmtech.com/pharmtech/In+the+Mixer/Designing-a-Clean-in-Place-System/ArticleStandard/Article/detail/796777?contextCategoryId=40939&ref=25 An efficient cleaning cycle begins with equipment and automation-system design. 2012-11-21T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/462012/796777null HTML http://www.pharmtech.com/pharmtech/Manufacturing/Pharmaceutical-Stability-Scientific-and-Regulatory/ArticleStandard/Article/detail/797626?contextCategoryId=40939&ref=25 A two-day workshop on the "science behind pharmaceutical stability" was held in conjunction with the Annual Meeting of American Association of Pharmaceutical Scientists (AAPS) on Oct. 21-22, 2011 in Washington, DC. 2012-11-03T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/482012/797626null XML http://www.pharmtech.com/pharmtech/Feature+Articles/An-Industry-Perspective-on-Harmonization-and-Imple/ArticleStandard/Article/detail/795602?contextCategoryId=40939&ref=25 The US Pharmacopeia's revised General Chapters on elemental impurity limits and testing procedures are set to take effect in December 2012. 2012-11-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/452012/795602/Checkbox_thumbnail.gif http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/452012/795602null XML http://www.pharmtech.com/pharmtech/Peer-Reviewed+Research/Mean-Kinetic-Relative-Humidity-A-New-Concept-for-A/ArticleStandard/Article/detail/795607?contextCategoryId=40939&ref=25 This article introduces"mean kinetic relative humidity" for evaluating the impact of humidity variability. 2012-11-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/452012/795607/Humidity_thumbnail.gif http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/452012/795607null XML http://www.pharmtech.com/pharmtech/Packaging+%26+Labeling/Frozen-Assets/ArticleStandard/Article/detail/795608?contextCategoryId=40939&ref=25 Even when all is well at the facility, one must expect the worst while braving the elements. 2012-11-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/452012/795608null XML http://www.pharmtech.com/pharmtech/Feature+Articles/AAPS-Workshop-Summary/ArticleStandard/Article/detail/795603?contextCategoryId=40939&ref=25 A two-day workshop on the "science behind pharmaceutical stability" was held in conjunction with the Annual Meeting of American Association of Pharmaceutical Scientists (AAPS) on Oct. 21-22, 2011 in Washington, DC. 2012-11-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/452012/795603null XML http://www.pharmtech.com/pharmtech/BioForum/Weighing-Access-and-Affordability/ArticleStandard/Article/detail/795610?contextCategoryId=40939&ref=25 Policymakers must balance fundamental issues involving access to medicines and pricing. 2012-11-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/452012/795610null XML http://www.pharmtech.com/pharmtech/Manufacturing/Will-Europe-Discourage-the-Launch-of-New-Alzheimer/ArticleStandard/Article/detail/797624?contextCategoryId=40939&ref=25 Regulatory bureaucracy in Europe coupled with the demand for lower-priced medicines continues to hinder efforts in innovation for Alzheimer's disease. 2012-11-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/482012/797624/Magnifying_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/482012/797624null XML http://www.pharmtech.com/pharmtech/In+the+Field/QampA-with-Yves-de-Montcheuil-of-Talend/ArticleStandard/Article/detail/795597?contextCategoryId=40939&ref=25 A Q&A with Yves de Montcheuil, vice-president of marketing at Talend, a provider of open-source integration software. 2012-11-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/452012/795597/thumbnail_thumbnail.gif http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/452012/795597null XML http://www.pharmtech.com/pharmtech/Troubleshooting/A-Troubleshooting-Guide-for-Topical-Drug-Manufactu/ArticleStandard/Article/detail/795598?contextCategoryId=40939&ref=25 Consider critical process parameters and strategies to optimize the manufacturing process. 2012-11-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/452012/795598/troubleshooting_thumbnail.gif http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/452012/795598null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Optimizing-Early-Stage-Drug-Development/ArticleStandard/Article/detail/795605?contextCategoryId=40939&ref=25 Pharmaceutical companies and contract service providers adapt strategies and capabilities to reduce costs and accelerate drug-development timelines. 2012-11-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/452012/795605/arrow_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/452012/795605null XML http://www.pharmtech.com/pharmtech/In+the+Field/Report-from-Turkey/ArticleStandard/Article/detail/795599?contextCategoryId=40939&ref=25 The government of Turkey is drawing up a program in coordination with the pharmaceutical industry to create ways to make the country a regional production center for pharmaceuticals serving Europe, Central Asia, and the Middle East. 2012-11-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/452012/795599/Turkey_thumbnail.gif http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/452012/795599null XML http://www.pharmtech.com/pharmtech/Ingredients/Analytical-Applications/ArticleStandard/Article/detail/795587?contextCategoryId=40939&ref=25 Developing analytical methods and performing related testing is crucial for ensuring the quality of a pharmaceutical product. 2012-11-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/452012/795587/LabWork_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/452012/795587null XML http://www.pharmtech.com/pharmtech/Analytics/Tools-for-Enabling-Process-Analytical-Technology-A/ArticleStandard/Article/detail/795590?contextCategoryId=40939&ref=25 In this paper, the authors review the various analytical methods that can enable use of PAT. 2012-11-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/452012/795590null XML http://www.pharmtech.com/pharmtech/Standards+%26+Regulation/Using-a-Systematic-Approach-to-Select-Critical-Pro/ArticleStandard/Article/detail/795585?contextCategoryId=40939&ref=25 Critical process parameters (CPPs) and their associated process controls are crucial to drug development and process validation and to the evaluation of every manufacturing unit operation. 2012-11-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/452012/795585null XML http://www.pharmtech.com/pharmtech/News/Patheon-to-Acquire-Banner-Pharmacaps/ArticleStandard/Article/detail/794745?contextCategoryId=40939&ref=25 Patheon will acquire softgel-specialist company Banner Pharmacaps, based in North Carolina in the US, for $255 million 2012-10-31T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/442012/794745null HTML http://www.pharmtech.com/pharmtech/News/Europe-Establishes-First-Facility-for-Cell-Based-T/ArticleStandard/Article/detail/793994?contextCategoryId=40939&ref=25 On Oct. 22, 2012, a consortium in France announced the establishment of Europe's first ever industrial manufacturing facility dedicated to the large-scale production of novel, advanced cell-based therapy medicinal products. 2012-10-24T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/432012/793994null HTML http://www.pharmtech.com/pharmtech/In+the+Mixer/Challenges-in-Topical-Drug-Manufacturing/ArticleStandard/Article/detail/792451?contextCategoryId=40939&ref=25 Consider these tools and strategies for optimizing the manufacturing process. 2012-10-17T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/412012/792451null HTML http://www.pharmtech.com/pharmtech/Production+Lines/Improving-Intelligent-Device-Management/ArticleStandard/Article/detail/792447?contextCategoryId=40939&ref=25 Strategic management of intelligent devices is important in any processing field, and a new standards committee at the International Society of Automation aims to provide direction so that manufacturers can better utilize the devices' capabilities. 2012-10-17T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/412012/792447null HTML http://www.pharmtech.com/pharmtech/Editor%27s+Picks/October-2012-Editors-Picks-Products-from-UFP-Techn/ArticleStandard/Article/detail/792464?contextCategoryId=40939&ref=25 PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the October 2012 edition from UFP Technologies and Mettler Toledo. 2012-10-17T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/412012/792464null HTML http://www.pharmtech.com/pharmtech/Manufacturing/Takeda-to-Acquire-LigoCyte-Pharmaceuticals/ArticleStandard/Article/detail/791682?contextCategoryId=40939&ref=25 Takeda's US subsidiary, Takeda America Holdings, has agreed to acquire the vaccine specialist company LigoCyte Pharmaceuticals for an upfront payment of $60 million in a move intended to bolster and expand the company's vaccine business. 2012-10-08T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/412012/791682null HTML http://www.pharmtech.com/pharmtech/Feature+Articles/Technical-Forum-Disposable-Chromatography/ArticleStandard/Article/detail/791894?contextCategoryId=40939&ref=25 PharmTech spoke with industry experts about the challenges of implementing disposable chromatography systems. 2012-10-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/412012/791894/71808550_web_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/412012/791894null XML http://www.pharmtech.com/pharmtech/Troubleshooting/Outsourcing-Pharmaceutical-Infrastructure-Operatio/ArticleStandard/Article/detail/791895?contextCategoryId=40939&ref=25 Today's pharmaceutical companies are striving to reduce costs and maximize efficiencies, and must make decisions on the best way to deploy their limited resources. 2012-10-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/412012/791895/Combined-CHP-graphic_web_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/412012/791895null XML http://www.pharmtech.com/pharmtech/Drug+Delivery/QampA-with-James-Ingebrand-3M-Drug-Delivery-System/ArticleStandard/Article/detail/791911?contextCategoryId=40939&ref=25 A Q&A with James Ingebrand, Vice President and General Manager of 3M Drug Delivery Systems Division, on recent industry trends. 2012-10-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/412012/791911/JamesIngebrand_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/412012/791911null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Early-Development-GMPs-for-Small-Molecule-Specific/ArticleStandard/Article/detail/791907?contextCategoryId=40939&ref=25 IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development. 2012-10-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/412012/791907/Molecule_Green_thumbnail.gif http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/412012/791907null XML http://www.pharmtech.com/pharmtech/Ingredients+Insider/Seeking-Solutions-in-Solid-State-Chemistry/ArticleStandard/Article/detail/791914?contextCategoryId=40939&ref=25 Particle-engineering technologies, such as crystal design for crystallization and producting cocrystals, particle-size reduction, and amorphous solid dispersions, help to optimize delivery of a drug. 2012-10-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/412012/791914/138142861-vitamin-c_web_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/412012/791914null XML http://www.pharmtech.com/pharmtech/Standards+%26+Regulation/Regulation-and-Compliance-QampA-on-483s/ArticleStandard/Article/detail/791908?contextCategoryId=40939&ref=25 Q&A with David Elder and Richard Wright of Strategic Compliance Consulting, PAREXEL International. Both Elder and Wright formerly served with FDA. 2012-10-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/412012/791908null XML http://www.pharmtech.com/pharmtech/Ingredients/Obtaining-Stable-Homogenous-Mixtures-with-Microniz/ArticleStandard/Article/detail/791902?contextCategoryId=40939&ref=25 The authors examine the use of various grades of direct-compression mannitol in direct-compression tableting process to evaluate the content uniformity of micronized APIs and excipients in a solid-dosage formulation. 2012-10-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/412012/791902/138087090_web_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/412012/791902null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Quality-by-Design-for-Analytical-Methods-Implicati/ArticleStandard/Article/detail/791903?contextCategoryId=40939&ref=25 The authors describe how traditional approaches to analytical method and validation may benefit from alignment with quality-by-design concepts. 2012-10-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/412012/791903/Figure-1_web_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/412012/791903/Bonus_main.gif http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/412012/791903null XML