http://www.pharmtech.com/pharmtech/Analytics/Article/list/40943 Analytical testing methods in pharma manufacturing. Chromatography, UHPLC, chiral. Near-infrared (NIR) and Raman spectroscopy. Anticounterfeiting. Dissolution testing. Cleaning validation. Extracables & leachables. 2013-05-23T13:56:18Z http://www.pharmtech.com/pharmtech/Analytics/Is-My-Method-Still-Valid/ArticleStandard/Article/detail/811595?contextCategoryId=40943&ref=25 This paper outlines the importance of method validation including the official requirements, characteristics to be validated and minimum requirements, helping to ensure that the data generated are reliable. 2013-04-25T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172013/811595null REMOTE http://www.pharmtech.com/pharmtech/Statistical+Solutions/Compositing-Samples-and-the-Risk-to-Product-Qualit/ArticleStandard/Article/detail/813392?contextCategoryId=40943&ref=25 Compositing samples is appropriate under certain circumstances but raises caveats on how and when it should be applied. 2013-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813392null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Enhancing-Particle-Size-Measurement-Using-Dry-Lase/ArticleStandard/Article/detail/813408?contextCategoryId=40943&ref=25 The author examines dry dispersion and outlines the related analytical method development. 2013-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813408/pt0513_prmalvern_thumg_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813408null XML http://www.pharmtech.com/pharmtech/Packaging+%26+Labeling/Preparing-for-Serialization/ArticleStandard/Article/detail/808136?contextCategoryId=40943&ref=25 Bristol-Myers Squibb embarks on a multi-year journey to overcome the challenges of serialization and reap the benefits. 2013-03-20T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/112013/808136null HTML http://www.pharmtech.com/pharmtech/Analytics/The-Role-of-Analytical-Science-in-Implementing-Qua/ArticleStandard/Article/detail/809037?contextCategoryId=40943&ref=25 The authors present topics discussed and conclusions that resulted from the PDA QbD workshop. 2013-03-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/142013/809037null XML http://www.pharmtech.com/pharmtech/Analytics/Catching-Up/ArticleStandard/Article/detail/809021?contextCategoryId=40943&ref=25 QbD paradigm advances process understanding in development and manufacturing. 2013-03-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/142013/809021null XML http://www.pharmtech.com/pharmtech/Analytics/The-Lifecycle-Change-of-Process-Validation-and-Ana/ArticleStandard/Article/detail/809040?contextCategoryId=40943&ref=25 Industry experts discuss the effect FDA's 2011 process validation guidance has had on industry. 2013-03-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/142013/809040null XML http://www.pharmtech.com/pharmtech/Packaging+%26+Labeling/Be-Prepared-for-Serialization/ArticleStandard/Article/detail/805489?contextCategoryId=40943&ref=25 Equipment purchased today for the packaging line should be serialization-ready in preparation for upcoming requirements. 2013-02-20T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/072013/805489null HTML http://www.pharmtech.com/pharmtech/Peer-Reviewed+Research/Improving-Inhaled-Product-Testing-Methods-for-Obta/ArticleStandard/Article/detail/804866?contextCategoryId=40943&ref=25 Even in an industry in which all product development is complicated by the intricacies of human biology, orally inhaled products (OIP) stand out as singularly demanding. 2013-02-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/062013/804866/inhaler_thumbnail.gif http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/062013/804866null XML http://www.pharmtech.com/pharmtech/Standards+%26+Regulation/Modernization-of-the-Standards-for-Elemental-Impur/ArticleStandard/Article/detail/804849?contextCategoryId=40943&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/Packaging+%26+Labeling/Logging-the-Cold-Chain/ArticleStandard/Article/detail/802229?contextCategoryId=40943&ref=25 Advances in data loggers and radio-frequency identification tags help meet the increasing need for managing the pharmaceutical cold chain. 2013-01-16T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/022013/802229null HTML http://www.pharmtech.com/pharmtech/Analytics/Tablet-Splitting-and-Analytical-Technologies/ArticleStandard/Article/detail/800616?contextCategoryId=40943&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/Peer-Reviewed+Research/X-ray-Powder-Diffraction-Pattern-Indexing-for-Phar/ArticleStandard/Article/detail/800851?contextCategoryId=40943&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/Troubleshooting/Using-Magnetic-Separation-to-Remove-Contamination/ArticleStandard/Article/detail/800037?contextCategoryId=40943&ref=25 Magnetic separation equipment reduces ferrous metal contamination. 2012-12-19T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/502012/800037null HTML http://www.pharmtech.com/pharmtech/Online+Only/Harnessing-the-Power-of-Fingerprinting-Technologie/ArticleStandard/Article/detail/798062?contextCategoryId=40943&ref=25 A few years ago, drug criminals would put all their efforts into matching packaging and labeling, or manufacturing good-looking fake materials. Today, criminals are capable of much more. 2012-12-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/482012/798062null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Patents-and-Postapproval-Batch-Testing/ArticleStandard/Article/detail/799111?contextCategoryId=40943&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/Troubleshooting/Using-As-Found-Data-in-a-Pipette-Calibration-Progr/ArticleStandard/Article/detail/796808?contextCategoryId=40943&ref=25 As-found data is a crucial component of pipette calibration for laboratories that must comply with GMP regulations. 2012-11-21T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/462012/796808null HTML http://www.pharmtech.com/pharmtech/Feature+Articles/Examining-the-Growing-Challenge-of-Extractables-an/ArticleStandard/Article/detail/795609?contextCategoryId=40943&ref=25 Experts share insight into extractables and leachables testing, including high-risk products, analytical testing, and regulatory requirements from FDA and EMA. 2012-11-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/452012/795609/TestTubes_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/452012/795609null XML http://www.pharmtech.com/pharmtech/Analytics/Stability-Program-Management/ArticleStandard/Article/detail/797628?contextCategoryId=40943&ref=25 To support global stability practices, fundamental basics must be in place. 2012-11-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/482012/797628null XML http://www.pharmtech.com/pharmtech/Feature+Articles/AAPS-Workshop-Summary/ArticleStandard/Article/detail/795603?contextCategoryId=40943&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/Peer-Reviewed+Research/Mean-Kinetic-Relative-Humidity-A-New-Concept-for-A/ArticleStandard/Article/detail/795607?contextCategoryId=40943&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/Standards+%26+Regulation/Using-a-Systematic-Approach-to-Select-Critical-Pro/ArticleStandard/Article/detail/795585?contextCategoryId=40943&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/Analytics/Tools-for-Enabling-Process-Analytical-Technology-A/ArticleStandard/Article/detail/795590?contextCategoryId=40943&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/Ingredients/Analytical-Applications/ArticleStandard/Article/detail/795587?contextCategoryId=40943&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/Determination-of-Higher-Order-Structure-and-Hydrog/ArticleStandard/Article/detail/795589?contextCategoryId=40943&ref=25 Hydrogen deuterium exchange by mass spectrometry is a powerful analytical approach that can be used to map higher order structures of proteins. 2012-11-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/452012/795589/waters_thumbnail.gif http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/452012/795589null XML http://www.pharmtech.com/pharmtech/Formulation/A-Novel-Process-for-Developing-Fully-Human-Monoclo/ArticleStandard/Article/detail/797630?contextCategoryId=40943&ref=25 The authors describe a process for generating high affinity, fully human antibodies in culture. 2012-11-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/482012/797630null XML http://www.pharmtech.com/pharmtech/Analytics/Moisture-Matters-in-Lyophilized-Drug-Product/ArticleStandard/Article/detail/797629?contextCategoryId=40943&ref=25 Using an alternate moisture-generation method may provide more accurate data for regulatory submissions. 2012-11-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/482012/797629null XML http://www.pharmtech.com/pharmtech/Analytics/Improving-Technology-Transfer/ArticleStandard/Article/detail/795591?contextCategoryId=40943&ref=25 This article focuses on the growing need for effective data management in the life sciences industry—especially among smaller pharmaceutical manufacturers. 2012-11-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/452012/795591/Molecule_Green_thumbnail.gif http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/452012/795591null XML http://www.pharmtech.com/pharmtech/Analytics/Nuclear-Magnetic-Resonance-as-a-Bioprocessing-QbD-/ArticleStandard/Article/detail/795588?contextCategoryId=40943&ref=25 The author discusses current expectations in bioprocessing and lays a framework for using NMR to enhance a QbD approach. 2012-11-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/452012/795588null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Combining-Spectroscopy-with-Automated-Imaging-A-Ne/ArticleStandard/Article/detail/795592?contextCategoryId=40943&ref=25 New systems that combine Raman spectroscopy with automated imaging support the efficient gathering of such data, including information concerning size and shape distributions for individual components within a formulation. 2012-11-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/452012/795592/Malvern_thumbnail.gif http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/452012/795592null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Developing-a-Comprehensive-Approach-for-Preventing/ArticleStandard/Article/detail/795586?contextCategoryId=40943&ref=25 This discussion aims to outline an approach to metal contamination prevention that should achieve a level of control acceptable to all stakeholders. 2012-11-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/452012/795586/cogs_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/452012/795586null XML http://www.pharmtech.com/pharmtech/Editor%27s+Picks/October-2012-Editors-Picks-Products-from-UFP-Techn/ArticleStandard/Article/detail/792464?contextCategoryId=40943&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/Analytical+%26+Bioanalytical+Solutions/Determining-Potency-of-Preclinical-Dose-Formulatio/ArticleStandard/Article/detail/791897?contextCategoryId=40943&ref=25 Potency is a required measurement to determine the amount of active ingredient contained in a preclinical dose formulation. Assessing potency ensures that the test system receives the appropriate amount of active ingredient based on predetermined specifications. 2012-10-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/412012/791897/red_spheres_thumbnail.gif http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/412012/791897null XML http://www.pharmtech.com/pharmtech/In+the+Spotlight/In-the-Spotlight/ArticleStandard/Article/detail/791893?contextCategoryId=40943&ref=25 New product reviews for October 2012, featuring analytical equipment. 2012-10-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/412012/791893null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Quality-by-Design-for-Analytical-Methods-Implicati/ArticleStandard/Article/detail/791903?contextCategoryId=40943&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 http://www.pharmtech.com/pharmtech/Feature+Articles/Integration-of-Less-Formal-Risk-Assessment-Tools-i/ArticleStandard/Article/detail/791909?contextCategoryId=40943&ref=25 Managing risk in biopharmaceutical operations is of utmost importance for patient protection. 2012-10-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/412012/791909/Risk_thumbnail.gif http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/412012/791909null XML http://www.pharmtech.com/pharmtech/Statistical+Solutions/Tools-in-Waiting-Time-for-Evolutionary-Operation/ArticleStandard/Article/detail/791898?contextCategoryId=40943&ref=25 Real-time experimentation may offer continuous process improvement. 2012-10-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/412012/791898null XML http://www.pharmtech.com/pharmtech/Packaging+%26+Labeling/Compliant-or-Contraband/ArticleStandard/Article/detail/787769?contextCategoryId=40943&ref=25 International trade can be great for business, but breaking border laws can put one in hot water. 2012-09-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/362012/787769null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Process-Analytical-Technology-Charting-Progress-in/ArticleStandard/Article/detail/787763?contextCategoryId=40943&ref=25 Industry experts share perspectives on analytical instrumentation, methods, and data analysis. 2012-09-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/362012/787763/PT0912_Cover-120x90_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/362012/787763null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Correlating-Product-Lifecycle-and-Manufacturing-Si/ArticleStandard/Article/detail/787758?contextCategoryId=40943&ref=25 MIT survey results address product and site characteristics that statistically correlate with quality performance. 2012-09-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/362012/787758null XML http://www.pharmtech.com/pharmtech/Analytics/Fast-Locator-2012-2013-Index/ArticleStandard/Article/detail/783000?contextCategoryId=40943&ref=25 View companies' outsourcing profiles from PharmTech's 2012 Outsourcing Resources Fast Locator Index in the following categories. 2012-09-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/302012/783000null HTML http://www.pharmtech.com/pharmtech/Outsourcing/Fast-Locator-2012-2013-Analytical-Services/ArticleStandard/Article/detail/787644?contextCategoryId=40943&ref=25 Companies' outsourcing profiles from PharmTech's 2012 Outsourcing Resources Fast Locator Index. 2012-09-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/362012/787644null HTML http://www.pharmtech.com/pharmtech/Ingredients/Achieving-Process-Understanding-and-Control-in-Fil/ArticleStandard/Article/detail/787883?contextCategoryId=40943&ref=25 The authors describe a QbD study that was performed to optimize a coating system. 2012-09-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/362012/787883null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Elemental-Impurity-Analysis/ArticleStandard/Article/detail/783931?contextCategoryId=40943&ref=25 The author discusses how to manage pending pharmacopeial changes. 2012-08-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/312012/783931/PT0812_PositionPaperMetalsCross__Web_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/312012/783931null XML http://www.pharmtech.com/pharmtech/Standards+%26+Regulation/Technology-Fights-Back/ArticleStandard/Article/detail/784025?contextCategoryId=40943&ref=25 Meticulous system configuration can prevent machines from taking over. 2012-08-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/312012/784025null XML http://www.pharmtech.com/pharmtech/In+the+Spotlight/In-the-Spotlight/ArticleStandard/Article/detail/783935?contextCategoryId=40943&ref=25 New product reviews for August 2012. 2012-08-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/312012/783935null XML http://www.pharmtech.com/pharmtech/Statistical+Solutions/A-Statistical-Review-of-ICH-emQ10-Pharmaceutical-Q/ArticleStandard/Article/detail/783929?contextCategoryId=40943&ref=25 Applying the recommendations of ICH Q10 to statistical analysis can help prevent product recalls. 2012-08-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/312012/783929null XML http://www.pharmtech.com/pharmtech/In+the+Mixer/Analytical-Tools-for-a-Quality-by-Design-Approach-/ArticleStandard/Article/detail/781268?contextCategoryId=40943&ref=25 Experts share insights into analytical tools and techniques. 2012-07-18T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/282012/781268null HTML http://www.pharmtech.com/pharmtech/Statistical+Solutions/How-to-Assess-Preclinical-Dose-Formulation-Homogen/ArticleStandard/Article/detail/781208?contextCategoryId=40943&ref=25 Uniform dose formulation is key to meeting safety study requirements. 2012-07-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/282012/781208null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Atypical-Visible-Particles/ArticleStandard/Article/detail/781195?contextCategoryId=40943&ref=25 An industry roundtable on how users and makers can best assess and manage black specks. 2012-07-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/282012/781195/PT0712_RTpic1_web_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/282012/781195null XML http://www.pharmtech.com/pharmtech/Standards+%26+Regulation/A-Lukewarm-Reception/ArticleStandard/Article/detail/781204?contextCategoryId=40943&ref=25 Careful attention to detail will help to prevent valuable assets from "melting" away. 2012-07-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/282012/781204null XML http://www.pharmtech.com/pharmtech/Analytics/35th-Anniversary-Special-The-Today-and-Tomorrow-of/ArticleStandard/Article/detail/783092?contextCategoryId=40943&ref=25 Industry experts share perspectives on analytical instrumentation, methods, and data analysis. 2012-07-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/302012/783092null XML http://www.pharmtech.com/pharmtech/Statistical+Solutions/PlacketndashBurman-Designs/ArticleStandard/Article/detail/781194?contextCategoryId=40943&ref=25 Applying current principals to traditional factorial designs. 2012-07-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/282012/781194null XML http://www.pharmtech.com/pharmtech/Feature+Articles/35th-Anniversary-Special-Breakthroughs-and-Emergin/ArticleStandard/Article/detail/781197?contextCategoryId=40943&ref=25 Industry experts share their insight on solid-dosage and sterile manufacturing. 2012-07-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/282012/781197null XML http://www.pharmtech.com/pharmtech/In+the+Mixer/A-Practical-Guide-to-Pan-Coating-and-Scale-Up/ArticleStandard/Article/detail/777748?contextCategoryId=40943&ref=25 An understanding of the pan-coating process based on first principles can support successful scale up. 2012-06-20T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/242012/777748null XML http://www.pharmtech.com/pharmtech/Standards+%26+Regulation/A-Big-E-on-the-Scoreboard/ArticleStandard/Article/detail/775984?contextCategoryId=40943&ref=25 Even the slightest of errors in exponential calculations can cause the biggest of headaches. 2012-06-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/222012/775984null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Looking-for-Fingerprints-Bioanalytical-Characteriz/ArticleStandard/Article/detail/775978?contextCategoryId=40943&ref=25 Extensive physicochemical characterization of the innovator product and the proposed biosimilar provides the foundation for demonstrating biosimilarity. 2012-06-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/222012/775978/PT0612_CV1_Cover_120x90_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/222012/775978null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Preclinical-Dose-Formulation-Stability/ArticleStandard/Article/detail/775994?contextCategoryId=40943&ref=25 When designing stability protocols, formulation, storage, and dosing conditions must be assessed. 2012-06-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/222012/775994/PT0612_60_122373979_63perc_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/222012/775994null XML http://www.pharmtech.com/pharmtech/Editor%27s+Picks/May-2012-Editors-Picks-Products-from-Koslow-Scient/ArticleStandard/Article/detail/772821?contextCategoryId=40943&ref=25 PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the May 2012 edition from Koslow Scientific Company and Vaisala. 2012-05-16T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192012/772821null HTML http://www.pharmtech.com/pharmtech/Production+Lines/Ongoing-Challenges-in-Continuous-Manufacturing/ArticleStandard/Article/detail/772973?contextCategoryId=40943&ref=25 Advances in process analytical technology and in defining lots for release are key for enabling use of continuous processes in solid-dosage manufacturing. 2012-05-16T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192012/772973null HTML http://www.pharmtech.com/pharmtech/Regulatory+Corner/FDA-Perspectives-Scientific-Considerations-of-Forc/ArticleStandard/Article/detail/771905?contextCategoryId=40943&ref=25 The author outlines the scientific aspects of forced degradation studies that should be considered in relation to ANDA submissions. 2012-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771905null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Optimizing-Tableting-Processes-with-Quality-by-Des/ArticleStandard/Article/detail/771890?contextCategoryId=40943&ref=25 A technical forum featuring Tim Freeman of Freeman Technology and Carl Levoguer of Malvern Instruments. 2012-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771890/PT0512_200464087-001_48_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771890null XML http://www.pharmtech.com/pharmtech/Standards+%26+Regulation/All-Eyes-Alert/ArticleStandard/Article/detail/771904?contextCategoryId=40943&ref=25 It's better to catch costly mistakes in the laboratory before they reach the accounting department. 2012-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771904null XML http://www.pharmtech.com/pharmtech/Manufacturing/Atomic-Force-Microscopy/ArticleStandard/Article/detail/771027?contextCategoryId=40943&ref=25 An analytical technique that is receiving increased attention in the pharmaceutical industry is atomic force microscopy. We interview Mark Leaper from the UK's De Montfort University to find out more about this technology. 2012-05-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172012/771027null XML http://www.pharmtech.com/pharmtech/Standards+%26+Regulation/Biological-Indicator-Growout-Times-The-Impact-on-E/ArticleStandard/Article/detail/771887?contextCategoryId=40943&ref=25 The authors provide a review of test methodology and standards, including current industry and regulatory proposals, for biological indicator growout times. 2012-05-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771887null XML http://www.pharmtech.com/pharmtech/Outsourcing/Bioprocessing-Trends-Annual-Survey-Results/ArticleStandard/Article/detail/771885?contextCategoryId=40943&ref=25 Readers share their views on bioprocessing challenges, equipment use, and outsourcing trends in our annual bioprocessing equipment and processing survey. 2012-05-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771885/PTsupp0512_Cv1_120x90_thumbnail.jpg XML http://www.pharmtech.com/pharmtech/Standards+%26+Regulation/Parametric-Release-and-Real-Time-Release-Testing/ArticleStandard/Article/detail/771883?contextCategoryId=40943&ref=25 Parametric release and real-time testing use manufacturing data to ensure that products are made according to defined standards. PharmTech talks to Boehringer Ingelheim's Heribert Hausler about these issues. 2012-05-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771883null XML http://www.pharmtech.com/pharmtech/Analytics/Rapid-Microbial-Testing/ArticleStandard/Article/detail/771886?contextCategoryId=40943&ref=25 In this technical forum, experts describe different methods of rapid microbial testing and their applications. 2012-05-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771886/PTsupp_56961327_s14_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771886null XML http://www.pharmtech.com/pharmtech/In+the+Spotlight/In-the-Spotlight/ArticleStandard/Article/detail/768873?contextCategoryId=40943&ref=25 New product reviews for April 2012. 2012-04-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/152012/768873null XML http://www.pharmtech.com/pharmtech/Standards+%26+Regulation/Loose-Lips-Sink-Ships/ArticleStandard/Article/detail/768874?contextCategoryId=40943&ref=25 Failure to disclose info may work sometimes, but eventually every question will be answered. 2012-04-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/152012/768874null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Managing-Product-Supply-Risks/ArticleStandard/Article/detail/768878?contextCategoryId=40943&ref=25 How to use geographic diversification and legacy technology transfers to avoid product shortages. 2012-04-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/152012/768878/PT0412_78401921_Web_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/152012/768878null XML http://www.pharmtech.com/pharmtech/IT/In-the-Spotlight/ArticleStandard/Article/detail/763942?contextCategoryId=40943&ref=25 New product reviews for March 2012. 2012-03-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/102012/763942null XML http://www.pharmtech.com/pharmtech/Standards+%26+Regulation/Total-Recall/ArticleStandard/Article/detail/763931?contextCategoryId=40943&ref=25 In a world where product recalls can mean the end of a company, all batches must be perfect. 2012-03-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/102012/763931null XML http://www.pharmtech.com/pharmtech/Peer-Reviewed+Research/Evaluating-Impurities-in-Drugs-Part-II-of-III/ArticleStandard/Article/detail/763932?contextCategoryId=40943&ref=25 In Part II of a three-part article, the authors examine impurities from chiral molecules, polymorphic contaminants, and genotoxic impurities. 2012-03-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/102012/763932/PT0212_46_95012107_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/102012/763932null XML http://www.pharmtech.com/pharmtech/Analytics/Genotoxic-Impurities-A-QampA-with-Amgens-Bo-Shen/ArticleStandard/Article/detail/763934?contextCategoryId=40943&ref=25 Genotoxic impurities and how to identify them and control for them have been a concern for several years in the pharmaceutical manufacturing industry. Pharmaceutical Technology spoke with Bo Shen, PhD, principal scientist at Amgen and chair of the AAPS Pharmaceutical Trace Impurities Focus Group, to gain insight on key challenges. 2012-03-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/102012/763934null XML http://www.pharmtech.com/pharmtech/Standards+%26+Regulation/In-the-Spotlight/ArticleStandard/Article/detail/757444?contextCategoryId=40943&ref=25 New product reviews for February 2012. 2012-02-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757444null XML http://www.pharmtech.com/pharmtech/Standards+%26+Regulation/Shipping-with-the-Enemy/ArticleStandard/Article/detail/757442?contextCategoryId=40943&ref=25 A nickel's worth of free advice to the competition could come at the expense of your bottom line. 2012-02-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757442null XML http://www.pharmtech.com/pharmtech/Peer-Reviewed+Research/Evaluating-Impurities-in-Drugs-Part-I-of-III/ArticleStandard/Article/detail/757445?contextCategoryId=40943&ref=25 In Part I of a three-part article, the authors discuss what constitutes an impurity and the potential sources of impurities in APIs and finished drug products. 2012-02-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757445/PT0212_46_95012107_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757445null XML http://www.pharmtech.com/pharmtech/Outsourcing/Report-from-India/ArticleStandard/Article/detail/757454?contextCategoryId=40943&ref=25 The Asian nation is strategizing to take the lead over its regional competitors in pharmaceutical exports. 2012-02-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757454/PT0212_16_101884043_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757454null XML http://www.pharmtech.com/pharmtech/Outsourcing/Report-from-Europe/ArticleStandard/Article/detail/754382?contextCategoryId=40943&ref=25 The European Union market takes steps toward continuous processing and modular facilities. 2012-01-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/532011/754382/PT0112_18_73829699_web_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/532011/754382null XML http://www.pharmtech.com/pharmtech/Standards+%26+Regulation/All-Systems-Slow/ArticleStandard/Article/detail/754375?contextCategoryId=40943&ref=25 Technology may expedite operations, but the absence of the human element could cost dearly. 2012-01-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/532011/754375null XML http://www.pharmtech.com/pharmtech/Editor%27s+Picks/December-2011-Editors-Picks-Products-from-Banner-E/ArticleStandard/Article/detail/752606?contextCategoryId=40943&ref=25 PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the December 2011 edition from Banner Engineering and Eriez. 2011-12-21T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/512011/752606null HTML http://www.pharmtech.com/pharmtech/Online+Only/Moving-from-a-Reactive-to-a-Systemic-Approach-to-M/ArticleStandard/Article/detail/752605?contextCategoryId=40943&ref=25 Risk assessment is not a new concept to the pharmaceutical industry, but lately the phrase has become a mantra. A systemic, science-based way to manage risk is becoming essential to meeting the spirit and letter of FDA requirements. 2011-12-21T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/512011/752605null HTML http://www.pharmtech.com/pharmtech/Ingredients/Views-from-Pharma-Leaders-A-Year-in-Review-and-a-L/ArticleStandard/Article/detail/751296?contextCategoryId=40943&ref=25 Drug shortages, supply-chain security, generic-drug incursion, and flexible manufacturing models are some of the issues shaping the bio/pharma industry. 2011-12-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/492011/751296/PT1211_Cover_120-x-90_web_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/492011/751296null XML http://www.pharmtech.com/pharmtech/Ingredients/PQRI-Case-Study-8-Internal-GMP-Audit-Program/ArticleStandard/Article/detail/751282?contextCategoryId=40943&ref=25 The last in a series of eight case studies from the Product Quality Research Institute focuses on internal GMP audits. 2011-12-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/492011/751282/PT1211_PQRICaseStudy8_web_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/492011/751282/onlineEX_main.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/492011/751282null XML http://www.pharmtech.com/pharmtech/Ingredients/PQRI-Case-Study-6-Packaging-Line-GMP-Optimization/ArticleStandard/Article/detail/751292?contextCategoryId=40943&ref=25 The sixth in a series of eight case studies from the Product Quality Research Institute focuses on packaging line GMP optimization. 2011-12-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/492011/751292/PT1211_47_Case-Study-05-Table-2-Example-Frequency-Categories_web_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/492011/751292null XML http://www.pharmtech.com/pharmtech/Ingredients/PQRI-Case-Study-7-PackOut-Remedies-to-Minimize-Con/ArticleStandard/Article/detail/751283?contextCategoryId=40943&ref=25 The seventh in a series of eight case studies from the Product Quality Research Institute focuses on packout remedies. 2011-12-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/492011/751283/PT1211_PQRICaseStudy7_web_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/492011/751283/onlineEX_main.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/492011/751283null XML http://www.pharmtech.com/pharmtech/Statistical+Solutions/Out-of-Specification-Sample-Size-Confusion/ArticleStandard/Article/detail/751289?contextCategoryId=40943&ref=25 Precedents set in the historic Barr case continue to raise questions over suitable sample-size criteria. 2011-12-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/492011/751289null XML http://www.pharmtech.com/pharmtech/Outsourcing/Buzz-Off-the-Product/ArticleStandard/Article/detail/751299?contextCategoryId=40943&ref=25 Cleanliness is crucial, even if zapping and trapping is necessary to reduce product contamination. 2011-12-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/492011/751299null XML http://www.pharmtech.com/pharmtech/Ingredients/The-Employment-Outlook-Brightens/ArticleStandard/Article/detail/751286?contextCategoryId=40943&ref=25 Readers react to the economic turmoil of the past year and look longingly forward to 2012. 2011-12-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/492011/751286/PT1211_32_103772148_web_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/492011/751286null XML http://www.pharmtech.com/pharmtech/IT/Easy-on-the-Alcohol/ArticleStandard/Article/detail/747438?contextCategoryId=40943&ref=25 Careful mixing during a product's distillation can help avert trouble from a strong concoction. 2011-11-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/452011/747438null XML http://www.pharmtech.com/pharmtech/Ingredients/Water-Intrusion-Test-Integration/ArticleStandard/Article/detail/747432?contextCategoryId=40943&ref=25 The authors describe the operational qualification of test accuracy with regard to temperature drift using a thermal-compensation algorithm on several freeze dryers. 2011-11-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/452011/747432null XML http://www.pharmtech.com/pharmtech/In+the+Spotlight/In-the-Spotlight/ArticleStandard/Article/detail/747439?contextCategoryId=40943&ref=25 New product reviews for November 2011. 2011-11-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/452011/747439null XML http://www.pharmtech.com/pharmtech/Ingredients/PQRI-Case-Study-5-Nonsterile-Facility-Cleaning-Req/ArticleStandard/Article/detail/747435?contextCategoryId=40943&ref=25 The fifth in a series of eight case studies from the Product Quality Research Institute focuses on nonsterile facility cleaning requirements. 2011-11-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/452011/747435null XML http://www.pharmtech.com/pharmtech/Analytics/Protein-Sensitivity-to-Tungsten/ArticleStandard/Article/detail/747422?contextCategoryId=40943&ref=25 The authors investigate the effect of low pH and ionic strength on aggregation using turbidity measurements and size-exclusion–high-performance liquid chromatography. 2011-11-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/452011/747422null XML http://www.pharmtech.com/pharmtech/IT/Addressing-Elemental-Impurity-Limits-with-ICPndash/ArticleStandard/Article/detail/747421?contextCategoryId=40943&ref=25 The US Pharmacopeia (USP) proposes to lower the maximum permissible limits of trace elements in pharmaceuticals and recommends that impurities be measured through automated instrumentation-based methods. The proposed regulations specify inductively coupled plasma–mass spectrometry (ICP–MS) and inductively coupled plasma–optical emission spectrometry (ICP–OES) as the techniques of choice. This article discusses the benefits of ICP–MS and ICP–OES for the accurate detection of trace elements in pharmaceutical products, in compliance with the proposed USP chapters. 2011-11-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/452011/747421null XML http://www.pharmtech.com/pharmtech/IT/NMR-Reaction-Monitoring-as-a-Process-Analytical-Te/ArticleStandard/Article/detail/747428?contextCategoryId=40943&ref=25 The authors describe the benefits of nuclear magnetic resonance (NMR) compared with traditional monitoring techniques. They also discuss how NMR reaction monitoring provides a new process analytical technology tool for industry. 2011-11-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/452011/747428null XML http://www.pharmtech.com/pharmtech/Analytics/Under-Continuous-Consideration/ArticleStandard/Article/detail/746099?contextCategoryId=40943&ref=25 Continuous manufacturing is increasingly noted as an important long-term objective for the pharmaceutical industry. PTE talks with Tim Freeman, Director of Operations at Freeman Technology, about some of the central issues involved in this transition, as well as the supporting role of relevant analytical technology. 2011-11-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/442011/746099null XML http://www.pharmtech.com/pharmtech/Analytics/The-Causes-and-Implications-of-Glass-Delamination/ArticleStandard/Article/detail/747427?contextCategoryId=40943&ref=25 This article focuses on the history of glass delamination and methods that detect it, both from a compendial and a research perspective. 2011-11-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/452011/747427null XML http://www.pharmtech.com/pharmtech/Analytics/Inhaled-Product-Characterization/ArticleStandard/Article/detail/747424?contextCategoryId=40943&ref=25 The authors discuss the analysis of the resulting data, focusing on methods for the calculation of mass median aerodynamic diameter, one of the metrics routinely used for comparative testing. 2011-11-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/452011/747424null XML