http://pharmtech.findpharma.com/pharmtech A publication providing practical information on pharmaceutical manufacturing. Content focuses on applied R&D technology, process control and computer-integrated manufacturing, biotechnology and technical management. 2008-11-21T02:27:33Z http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-Patheon-and-Solvias-Form-/ArticleStandard/Article/detail/567121?ref=25 Also, BASi opens European office in Warwickshire, UK; Acusphere's Howard Bernstein Resigns; More... 2008-11-20T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/472008/567121null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/Ranbaxy-Responds-to-US-Investigation/ArticleStandard/Article/detail/567067?ref=25 Ranbaxy Laboratories (Gurgaon, Haryana, India) responded to an investigation of violations at two of its manufacturing plants, according to a Reuters Health report. 2008-11-20T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/472008/567067null HTML http://pharmtech.findpharma.com/pharmtech/Regulation/New-Draft-Guidance-on-Process-Validation/ArticleStandard/Article/detail/567069?ref=25 The US Food and Drug issued a draft guidance on Tuesday, Nov. 18, titled Process Validation: General Principles and Practices for comment. The guidance is meant to serve as a revision to the 1987 Guideline on General Principles of Process Validation. 2008-11-20T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/472008/567069null HTML http://pharmtech.findpharma.com/pharmtech/Regulation/Civil-Money-Penalties-Increased/ArticleStandard/Article/detail/567068?ref=25 The US Food and Drug Administration issued a direct final rule last week to adjust for inflation the maximum civil money penalty amounts for various civil money penalty authorities under the agency's jurisdiction. 2008-11-20T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/472008/567068null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/Most-New-Drugs-Approved-Worldwide-Were-First-Marke/ArticleStandard/Article/detail/567065?ref=25 Although the number of annual new-drug approvals in the United States has steadily declined during the past ten years, pharmaceutical companies still prefer to introduce new products in the US first, according to a report published by the Tufts Center for the Study of Drug Development. 2008-11-20T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/472008/567065null HTML http://pharmtech.findpharma.com/pharmtech/Whitepapers/Investigating-the-confined-and-unconfined-flow-beh/ArticleStandard/Article/detail/566472?ref=25 Powders can exhibit very different behaviors depending on the conditions to which they are subjected during storage, handling or processing. This paper examines the mechanisms associated with powder flow, contrasting the way in which materials behave when confined and unconfined. Understanding this important aspect of behavior is a significant step towards knowledge-based processing, as advocated by QbD. 2008-11-17T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/472008/566472null REMOTE http://pharmtech.findpharma.com/pharmtech/Ingredients/FDA-Seizes-Tainted-Heparin-from-Celsus/ArticleStandard/Article/detail/565605?ref=25 US marshals seized 11 lots of heparin from Celsus Laboratories (Cincinnati, OH) at the request of the US Food and Drug Administration. 2008-11-13T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/462008/565605null HTML http://pharmtech.findpharma.com/pharmtech/News/ICH-Leaders-Meet/ArticleStandard/Article/detail/565606?ref=25 The Steering Committee and Expert Working Groups of the International Conference on Harmonization are meeting this week in Brussels to discuss current harmonization efforts. 2008-11-13T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/462008/565606null HTML http://pharmtech.findpharma.com/pharmtech/Regulation/Dingell-Aims-to-Boost-FDA-Funding/ArticleStandard/Article/detail/565608?ref=25 Rep. John Dingell (D-MI) plans to introduce the Food and Drug Globalization Act discussion draft as a bill early next year. 2008-11-13T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/462008/565608null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/Novo-Nordisk-to-Invest-400-Million-in-China/ArticleStandard/Article/detail/565604?ref=25 Novo Nordisk will invest nearly $400 million to build a new insulin plant in Tianjin, China. 2008-11-13T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/462008/565604null HTML http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-Amylin-AP-Pharma-Avigen-a/ArticleStandard/Article/detail/565672?ref=25 Also, Patheon opens new European headquarters, Cynvec appoints Frank D. Stonebanks president and CEO, more... 2008-11-13T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/462008/565672null HTML http://pharmtech.findpharma.com/pharmtech/Online+Only/November-2008-Editors-Picks-Products-from-ResistoP/ArticleStandard/Article/detail/565035?ref=25 PharmTech's monthly newsletter, Equipment & Processing Report, reviews the Editor's Picks for the November 2008 edition from ResistoPure and Millipore. 2008-11-12T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/462008/565035null HTML http://pharmtech.findpharma.com/pharmtech/Testing/Quality-Is-in-the-Eye-of-the-Inspection-System/ArticleStandard/Article/detail/565188?ref=25 Until recently, automated inspection of solid-dose pharmaceuticals was crude, expensive, slow, and difficult to change over. But technological advances have ushered in a new class of vision-inspection systems that is more effective and more commercially viable than older systems. 2008-11-12T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/462008/565188null HTML http://pharmtech.findpharma.com/pharmtech/Testing/A-Propitious-Period-for-PAT/ArticleStandard/Article/detail/565184?ref=25 PAT may reduce costs by helping companies control process variability, improve yields, reduce waste, and produce high-quality therapies consistently. Companies that have not yet embraced PAT may find its potential to reduce expenses a compelling argument in its favor during this time of financial difficulty. 2008-11-12T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/462008/565184null HTML http://pharmtech.findpharma.com/pharmtech/Whitepapers/Selecting-Magnetic-Equipment/ArticleStandard/Article/detail/564501?ref=25 When used properly, magnetic separation equipment can virtually eliminate ferrous metal contamination from dry or liquid products. This paper describes magnet materials and styles, and application considerations that are important to bear in mind during the selection process. It also provides an overview of different types of separation equipment. 2008-11-07T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452008/564501null REMOTE http://pharmtech.findpharma.com/pharmtech/Whitepapers/Protection-Through-Metal-Detection/ArticleStandard/Article/detail/564502?ref=25 This paper offers the reader a comprehensive look at state-of-the-art metal detectors. It describes the layout, performance characteristics, positioning techniques and operation and maintenance basics for today's metal detectors. 2008-11-07T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452008/564502null REMOTE http://pharmtech.findpharma.com/pharmtech/News/FDA-Requires-Side-Effects-Statement-on-Labeling/ArticleStandard/Article/detail/563389?ref=25 The US Food and Drug Administration has issued a final rule requiring the addition of a statement and toll-free number to the labeling of certain human drug products. 2008-11-06T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452008/563389null HTML http://pharmtech.findpharma.com/pharmtech/News/Supreme-Court-PhRMA-Present-Arguments-on-Preemptio/ArticleStandard/Article/detail/563383?ref=25 Arguments in the Supreme Court case Wyeth v. Levine have concluded, leaving both sides to wait possibly until early 2009 for a decision in a preemption case involving the misadministration of Wyeth's "Phenergan." 2008-11-06T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452008/563383null HTML http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-GSK-to-Acquire-Genelabs-T/ArticleStandard/Article/detail/563548?ref=25 Also, Sartorius Stedim Biotech GmbH to acquire Wave Biotech; AstraZeneca's John Patterson to retire; more... 2008-11-06T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452008/563548null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/FDA-Warns-Bayer-about-Marketing-Unapproved-Drugs/ArticleStandard/Article/detail/563385?ref=25 The US Food and Drug Administration sent Warning Letters to Bayer HealthCare (Morristown, NJ) about the company's "Bayer Women?s Low Dose Aspirin + Calcium" and "Bayer Aspirin with Heart Advantage" over-the-counter (OTC) products. 2008-11-06T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452008/563385null HTML http://pharmtech.findpharma.com/pharmtech/Ingredients/EMEA-Recommends-Rx-to-OTC-Switch-for-Orlistat/ArticleStandard/Article/detail/563392?ref=25 The European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use recommended that the status of GlaxoSmithKline's anti-obesity drug "Alli" (orlistat) be switched from prescription-only to nonprescription. 2008-11-06T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452008/563392null HTML http://pharmtech.findpharma.com/pharmtech/Outsourcing+Outlook/Minding-Your-Ps-and-Qs/ArticleStandard/Article/detail/562153?ref=25 As offshore savings decline, pharmaceutical companies still have a lot of work to do to reduce costs. 2008-11-05T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442008/562153null XML http://pharmtech.findpharma.com/pharmtech/Global-Pharmaceutical-Growth-Tempered-by-Lagging-U/ArticleStandard/Article/detail/562151?ref=25 Near-stagnant growth for the US pharmaceutical market, the rising influence of emerging markets and specialty products, and increased penetration of generic drugs are major issues for the global pharmaceutical market. 2008-11-05T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442008/562151null HTML http://pharmtech.findpharma.com/pharmtech/US-Biotech-Financing-Expected-to-Reach-Decade-Low-/ArticleStandard/Article/detail/562152?ref=25 Uncertain economic times crimp the financing flow into the US biotechnology industry. 2008-11-05T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442008/562152null HTML http://pharmtech.findpharma.com/pharmtech/Regulation+Article/Holey-Smoked-Fish-Flakes/ArticleStandard/Article/detail/564656?ref=25 Production problems come in all shapes, sizes, and ... species. 2008-11-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452008/564656null XML http://pharmtech.findpharma.com/pharmtech/Article/Trends-In-Foreign-Inspections/ArticleStandard/Article/detail/566180?ref=25 2008-11-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/462008/566180null XML http://pharmtech.findpharma.com/pharmtech/Ingredients/A-Fresh-Coat-Innovation-in-Excipients/ArticleStandard/Article/detail/564660?ref=25 Sophisticated excipient development, especially for coatings, is staying on top of new challenges and meeting expanding industry needs. 2008-11-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452008/564660/p46_flash.jpg XML http://pharmtech.findpharma.com/pharmtech/Regulation+Article/Report-from-India/ArticleStandard/Article/detail/564653?ref=25 The Indian government may soon monopolize its pharmaceutical industry to cut costs and improve healthcare, but the move is sounding off alarm bells with the companies whose drug products are under review. 2008-11-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452008/564653/onlineEX_main.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452008/564653null XML http://pharmtech.findpharma.com/pharmtech/Outsourcing+Outlook/Leading-European-CMOs-Consolidate-Market-Positions/ArticleStandard/Article/detail/564668?ref=25 Despite challenges, contract manufacturers in Europe are enjoying considerable success. 2008-11-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452008/564668null XML http://pharmtech.findpharma.com/pharmtech/Article/Bringing-Certainties-to-a-Burgeoning-Field/ArticleStandard/Article/detail/564652?ref=25 A well-balanced guide to industrial bioseparations provides valuable information. 2008-11-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452008/564652/onlineEX_main.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452008/564652null XML http://pharmtech.findpharma.com/pharmtech/Article/Trends-In-FDA-Enforcement-Actions/ArticleStandard/Article/detail/566179?ref=25 2008-11-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/462008/566179null XML http://pharmtech.findpharma.com/pharmtech/Inside+Standards/IPECs-New-Safety-Evaluation-Procedure-A-QampA-with/ArticleStandard/Article/detail/564671?ref=25 IPEC Chairman Dave Schoneker discusses current efforts toward facilitating regulatory reviews of new excipients. 2008-11-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452008/564671/onlineEX_main.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452008/564671null XML http://pharmtech.findpharma.com/pharmtech/Inside+Standards/USP-Metals-Testing-A-Workshop-Report/ArticleStandard/Article/detail/564667?ref=25 Attendees at a recent workshop endorsed new methods to detect metals in drugs, dietary supplements, and food ingredients. 2008-11-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452008/564667null XML http://pharmtech.findpharma.com/pharmtech/IT/Bringing-AAPS-to-You/ArticleStandard/Article/detail/564655?ref=25 Pharmaceutical Technology will feature video coverage of AAPS this month. 2008-11-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452008/564655null XML http://pharmtech.findpharma.com/pharmtech/IT/Quality-Counts/ArticleStandard/Article/detail/564654?ref=25 Pharma companies could benefit from the lessons learned in this fall's financial crisis. 2008-11-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452008/564654null XML http://pharmtech.findpharma.com/pharmtech/Article/Coming-Down-the-Pike-Chaperones/ArticleStandard/Article/detail/566184?ref=25 Molecules called "chaperones" facilitate correct protein folding. 2008-11-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/462008/566184null XML http://pharmtech.findpharma.com/pharmtech/Regulation+Article/FDA-Collaborates-on-Nanotechnology-Research/ArticleStandard/Article/detail/564672?ref=25 The US Food and Drug Administration seeks to understand nanotechnology better and exercise appropriate oversight over products that incorporate it. 2008-11-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452008/564672/onlineEX_main.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452008/564672null XML http://pharmtech.findpharma.com/pharmtech/Packaging+%26+Labeling+Article/Pharma-Capsules/ArticleStandard/Article/detail/564669?ref=25 Brief pharmaceutical news items for November 2008. 2008-11-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452008/564669null XML http://pharmtech.findpharma.com/pharmtech/Ingredients/Science-and-Technology-of-Bioadhesive-Based-Target/ArticleStandard/Article/detail/564665?ref=25 Novel hydrophobic bioadhesive polymers and dosage designs are now available to effectively achieve tailored release kinetics of a broad range of drugs to meet the clinical needs. 2008-11-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452008/564665null XML http://pharmtech.findpharma.com/pharmtech/Formulation+Article/Dendrimers-and-Topical-Drug-Delivery/ArticleStandard/Article/detail/564664?ref=25 This review provides an update of how dendrimer technology is being applied to the development of novel systems for various topical delivery applications. 2008-11-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452008/564664/p88_flash.jpg XML http://pharmtech.findpharma.com/pharmtech/Regulation+Article/Compendial-Issues-A-Position-Paper-on-The-Ideal-Ph/ArticleStandard/Article/detail/564666?ref=25 The authors propose the creation of a single, global, "ideal pharmacopeia." 2008-11-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452008/564666null XML http://pharmtech.findpharma.com/pharmtech/Ingredients+Insider/Exploring-Solid-State-Chemistry/ArticleStandard/Article/detail/564661?ref=25 Optimizing the solid form of a drug reaps scientific and technical awards. 2008-11-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452008/564661null XML http://pharmtech.findpharma.com/pharmtech/IT/RFID-versus-Barcode/ArticleStandard/Article/detail/564670?ref=25 Data capture needs to be fast and reliable...so which automatic identification technology is best? 2008-11-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452008/564670null XML http://pharmtech.findpharma.com/pharmtech/Ingredients/Orally-Disintegrating-Tablets/ArticleStandard/Article/detail/564662?ref=25 The authors examine the effectiveness of an excipient comprised of mannitol, polyvinyl acetate, and crospovidone using model actives loperamide hydrogen chloride and caffeine. 2008-11-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452008/564662/p66_flash.jpg XML http://pharmtech.findpharma.com/pharmtech/Ingredients/The-Effect-of-Mill-Type-on-Two-Dry-Granulated-Plac/ArticleStandard/Article/detail/564663?ref=25 The authors evaluate the effect of various mill types on particle-size distribution, flowability, tabletability, and compactibility. 2008-11-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452008/564663null XML http://pharmtech.findpharma.com/pharmtech/Regulation+Article/Report-From-China/ArticleStandard/Article/detail/564657?ref=25 With government support, China's pharmaceutical equipment sector is trekking ahead despite challenges regarding the country's overall perceived product quality. 2008-11-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452008/564657null XML http://pharmtech.findpharma.com/pharmtech/Article/In-the-Spotlight/ArticleStandard/Article/detail/564658?ref=25 Editors' Picks of Pharmaceutical Science & Technology Innovations 2008-11-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452008/564658null XML http://pharmtech.findpharma.com/pharmtech/Formulation+Article/Nanotechnology-Challenges-FDA-and-Manufacturers/ArticleStandard/Article/detail/564659?ref=25 Policymakers weigh new rules to ensure the safety and quality of drugs made with tiny particles. 2008-11-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452008/564659null XML http://pharmtech.findpharma.com/pharmtech/Regulation+Article/USP-lt1117gt-Microbial-Best-Laboratory-Practices-A/ArticleStandard/Article/detail/564642?ref=25 Scott Sutton discusses the current state of USP ‹1117› and USP's plans for future revisions. 2008-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452008/564642/onlineEX_main.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452008/564642null XML http://pharmtech.findpharma.com/pharmtech/Guidelines-for-Sourcing-amp-Management-eNewsletter/ArticleStandard/Article/detail/567417?ref=25 Guidelines for contributing articles to PharmTech's Sourcing & Management eNewsletter. 2008-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/472008/567417null PDF http://pharmtech.findpharma.com/pharmtech/Hallie-Forcinio/ArticleStandard/Article/detail/564992?ref=25 2008-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/462008/564992null HTML http://pharmtech.findpharma.com/pharmtech/Testing+Article/Freeze-Drying-with-Closed-Vials/ArticleStandard/Article/detail/564639?ref=25 The authors present an aseptic-filling process for freeze-dried liquids using the closed-vial technology. 2008-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452008/564639null XML http://pharmtech.findpharma.com/pharmtech/Guidelines-for-Short-Papers/ArticleStandard/Article/detail/567414?ref=25 Guidelines for writing short papers, technical notes and case studies. 2008-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/472008/567414null PDF http://pharmtech.findpharma.com/pharmtech/Article/Manufacturing-High-Potency-Drugs-Using-Isolators/ArticleStandard/Article/detail/564638?ref=25 The author discusses the key issues to consider when using isolators such as containment, protection of personnel, the efficiency of biodecontamination cycles, sterility assurance levels, barriers and their integrity, and environmental impact. 2008-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452008/564638null XML http://pharmtech.findpharma.com/pharmtech/Online+Exclusive/Comparison-of-Conventional-Cleanrooms-Restricted-A/ArticleStandard/Article/detail/564640?ref=25 A comparison of conventional cleanrooms, restricted access barrier systems, and isolators, shows the benefits of using isolators in high-potency drug manufacturing. 2008-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452008/564640/onlineEX_main.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452008/564640null XML http://pharmtech.findpharma.com/pharmtech/Testing+Article/Improving-the-Integrity-Test-Assurance-of-Multirou/ArticleStandard/Article/detail/564636?ref=25 The authors describe a novel approach for the integrity testing of large sterile filter systems such as multiround housings and describe a multipoint diffusion test capable of detecting minor failures. 2008-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452008/564636null XML http://pharmtech.findpharma.com/pharmtech/Testing+Article/Establishing-Material-Compatibility-Process-Condit/ArticleStandard/Article/detail/564637?ref=25 The authors explain the factors that can cause a failure in a bubble-point integrity test and what to consider when a product-specific bubble point must be defined. 2008-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452008/564637null XML http://pharmtech.findpharma.com/pharmtech/Guidelines-for-Authors/ArticleStandard/Article/detail/487041?ref=25 Guidelines for Authors contributing articles to PharmTech. Also, see guidelines for short papers, supplements, Sourcing & Management eNewsletter articles, and PharmTech's Media Kit. 2008-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/042008/487041null HTML http://pharmtech.findpharma.com/pharmtech/Guidelines-for-Supplements/ArticleStandard/Article/detail/567416?ref=25 Guidelines for writing articles for supplements. 2008-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/472008/567416null PDF http://pharmtech.findpharma.com/pharmtech/Guidelines-for-Authors/ArticleStandard/Article/detail/567413?ref=25 Guidelines for authors of contributed articles. 2008-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/472008/567413null PDF http://pharmtech.findpharma.com/pharmtech/Testing+Article/Guidelines-for-Selecting-Normal-Flow-Filters/ArticleStandard/Article/detail/564641?ref=25 Proper selection of normal flow filters leads to increased process efficiency from early phase product development through to full-scale biopharmaceutical production. 2008-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452008/564641/onlineEX_main.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452008/564641null XML http://pharmtech.findpharma.com/pharmtech/Jim-Miller/ArticleStandard/Article/detail/564821?ref=25 2008-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/462008/564821null HTML http://pharmtech.findpharma.com/pharmtech/Jill-Wechsler/ArticleStandard/Article/detail/564998?ref=25 2008-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/462008/564998null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/Merck-to-Cut-7200-Jobs/ArticleStandard/Article/detail/561858?ref=25 Merck plans to cut approximately 7200 positions as part of its 2008 restructuring plan, according to an Oct. 22 release focused on the company's third-quarter financial results. 2008-10-30T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442008/561858null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/Pfizer-and-Lilly-Pay-for-Marketing-Practices/ArticleStandard/Article/detail/561856?ref=25 Pfizer and Lilly recently resolved issues related to their marketing practices for certain products. 2008-10-30T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442008/561856null HTML http://pharmtech.findpharma.com/pharmtech/IT/FDA-Awards-NIPTE-119-M-for-QbD-Guidance-Project/ArticleStandard/Article/detail/561850?ref=25 The US Food and Drug Administration has awarded the National Institute for Pharmaceutical Technology and Education (NIPTE), a not-for-profit organization comprising 11 universities, a $1.19 million contract to develop quality by design (QbD) guidance elements for design space and scale-up of unit operations. 2008-10-30T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442008/561850null HTML http://pharmtech.findpharma.com/pharmtech/Regulation/GAO-Recommends-Ways-to-Improve-FDA-Foreign-Inspect/ArticleStandard/Article/detail/561857?ref=25 The US Government Accountability Office (GAO) released a report last week that examines and provides recommendations for the US Food and Drug Administration's foreign inspection process, including the agency's data management, inspection frequency, and oversight of problems identified during inspections. 2008-10-30T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442008/561857null HTML http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-Avid-Bioservices-Signs-Ma/ArticleStandard/Article/detail/561956?ref=25 Also, Maxygen looks to costs, jobs; Receptor BioLogix appoints Dale R. Pfost CEO; more... 2008-10-30T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442008/561956null HTML http://pharmtech.findpharma.com/pharmtech/News/FDA-Draft-Guidance-Reviews-Priority-Review-Voucher/ArticleStandard/Article/detail/560519?ref=25 The US Food and Drug Administration released a draft guidance that reviews the agency's plan to offer priority-review vouchers to companies developing new treatments for neglected tropical diseases. 2008-10-23T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/432008/560519null HTML http://pharmtech.findpharma.com/pharmtech/IT/Lawmakers-Question-FDA-About-DTC-Website/ArticleStandard/Article/detail/560518?ref=25 Rep. John D. Dingell (D-MI), chairman of the US House of Representatives Committee on Energy and Commerce, and Rep. Bart Stupak (D-MI), chairman of the Oversight and Investigations Subcommittee, sent letters to the US Food and Drug Administration, Shaw Science Partners, and EthicAd to request information about a new FDA website. 2008-10-23T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/432008/560518null HTML http://pharmtech.findpharma.com/pharmtech/Formulation/Pfizer-and-UCB-Form-New-Company-to-Speed-Drug-Disc/ArticleStandard/Article/detail/560507?ref=25 Pfizer and UCB formed a technology company named Cyclofluidic with the aim of accelerating the drug-discovery process. 2008-10-23T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/432008/560507null HTML http://pharmtech.findpharma.com/pharmtech/News/HHS-to-Open-Offices-Abroad-Starting-with-China/ArticleStandard/Article/detail/560505?ref=25 The US Department of Health and Human Services (HHS) will send the first Food and Drug Administration staff to China, India, Europe, and Latin America before the end of 2008. 2008-10-23T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/432008/560505null HTML http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-Novartis-to-Acquire-Nekta/ArticleStandard/Article/detail/560595?ref=25 Also, MedImmune opens Cambridge, UK, facility and makes reverse engineering pact with Omninvest; BD Medicine appoints Carol Adiletto VP of clinical and regulatory affairs; more... 2008-10-23T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/432008/560595null HTML http://pharmtech.findpharma.com/pharmtech/News/PharmTech-Followup-Pediatric-Cough-and-Cold-Medici/ArticleStandard/Article/detail/558960?ref=25 During the past several months, Pharmaceutical Technology has been covering the US Food and Drug Administration's rulemaking on over-the-counter (OTC) cough and cold medications for children. 2008-10-15T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/422008/558960null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/MedPAC-Recommends-Public-Disclosure-of-Payments-to/ArticleStandard/Article/detail/558963?ref=25 At a public meeting, the Medicare Payment Advisory Commission (MedPAC) discussed its recommendation that Congress establish a national database to publicly reveal financial relationships between physicians and the pharmaceutical industry. 2008-10-15T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/422008/558963null HTML http://pharmtech.findpharma.com/pharmtech/Article/October-2008-Editors-Picks-Products-from-Cognex-an/ArticleStandard/Article/detail/558326?ref=25 PharmTech's monthly newsletter, Equipment & Processing Report, reviews the Editor's Picks for the October 2008 edition from Cognex and W.L. Gore and Associates. 2008-10-15T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/422008/558326null HTML http://pharmtech.findpharma.com/pharmtech/News/FDAs-Recruitment-Troubles-Real/ArticleStandard/Article/detail/558961?ref=25 The lack of appropriate financial resources for the US Food and Drug Administration's growing global agenda has been a pertinent topic of late?and now appropriate staffing has become a large concern. 2008-10-15T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/422008/558961null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/PharmTech-Followup-Fluoroquinolone-Antibiotics/ArticleStandard/Article/detail/558951?ref=25 FDA has completed its labeling updates to fluoroquinolone antimicrobial drugs. 2008-10-15T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/422008/558951null HTML http://pharmtech.findpharma.com/pharmtech/Ingredients/Congress-Probes-FDAs-Inspection-Process-of-Actavis/ArticleStandard/Article/detail/558946?ref=25 John Dingell (D-MI), chairman of the US House Committee on Energy and Commerce and Bart Stupak (D-MI), chairman of that committee's Subcomittee on Oversight and Investigations, directed a letter to US Food and Drug Administration Commissioner Andrew C. von Eschenbach to request further information regarding FDA's process for inspecting manufacturing facilities of the generic drug manufacturer Actavis following several product recalls by the company. 2008-10-15T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/422008/558946null HTML http://pharmtech.findpharma.com/pharmtech/Article/Keeping-It-Together-Reducing-Powder-Segregation-in/ArticleStandard/Article/detail/558361?ref=25 Vacuum-conveying technology is commonly used in the pharmaceutical industry to move materials through the processing line, blend ingredients in various solutions, and handle tablets. The vacuum conveying of powders and granules, however, must be performed properly to avoid segregation, the separation of ingredients that results in an uneven mixture. 2008-10-15T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/422008/558361null HTML http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-DSM-Anti-Infectives-to-Cl/ArticleStandard/Article/detail/559086?ref=25 Also, Millipore opens new membrane-casting manufacturing facility in Ireland; Surface Logix appoints Keith Dionne president, CEO, and a member of the board; more... 2008-10-15T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/422008/559086null HTML http://pharmtech.findpharma.com/pharmtech/Article/Using-Software-to-Integrate-MES-and-ERP-Systems/ArticleStandard/Article/detail/558359?ref=25 Integrating MES with enterprise resource planning (ERP) systems can bring companies greater control over production than before and make manufacturing processes more flexible. 2008-10-15T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/422008/558359null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/SPL-Now-Only-Acceptable-Format-for-CBER-Original-S/ArticleStandard/Article/detail/558937?ref=25 According to a July 11, 2008 memorandum posted by the Center for Biologics Evaluation and Research, starting Oct. 15, Health Level 7 structured product labeling in XML (extensible markup language) will be the only acceptable presentation in electronic format for the submission of content of labeling that CBER can process, review, and archive. 2008-10-15T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/422008/558937null HTML http://pharmtech.findpharma.com/pharmtech/Ingredients/EFCG-and-IPEC-Europe-Establish-an-Excipient-Certif/ArticleStandard/Article/detail/557375?ref=25 The European Fine Chemicals Group (EFCG) and the International Pharmaceutical Excipents Council of Europe (IPEC Europe) announced the formation of  a European Pharmaceutical Excipients Certification Project to develop advocacy and stakeholder management in Europe and to give advice to two European working teams as part of an effort to develop a certification program for manufacturers and distributors of pharmaceutical excipients. 2008-10-09T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412008/557375null HTML http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-Azopharma-Expands-Analyti/ArticleStandard/Article/detail/557698?ref=25 Also, Merck & Co. discontinues development of its obesity drug taranabant; Synthetech names Frederic Farkas director of manufacturing; more... 2008-10-09T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412008/557698null HTML http://pharmtech.findpharma.com/pharmtech/News/Decision-Delayed-for-Pediatric-Cough-and-Cold-Meds/ArticleStandard/Article/detail/557362?ref=25 The US Food and Drug Administration?s Center for Drug Evaluation and Research (CDER) held a public meeting on Oct. 2 to discuss over-the-counter (OTC) cough and cold medications for pediatric use. 2008-10-09T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412008/557362null HTML http://pharmtech.findpharma.com/pharmtech/Ingredients/Senate-Introduces-Bill-for-Country-Of-Origin-Label/ArticleStandard/Article/detail/557377?ref=25 A bill that would require country-of-origin labeling for active and inactive ingredients for all prescription and over-the-counter pharmaceuticals was introduced in the US Senate last week. 2008-10-09T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412008/557377null HTML http://pharmtech.findpharma.com/pharmtech/News/ePedigree-Requirements-to-Take-a-Few-More-Years/ArticleStandard/Article/detail/557376?ref=25 The electronic pedigree mandate for prescription drugs has been delayed again. California Gov. Arnold Schwarzenegger signed legislation that delays ePedigree implementation until 2015. 2008-10-09T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412008/557376null HTML http://pharmtech.findpharma.com/pharmtech/IT/Lawmakers-Investigate-Irregular-FDA-Contract/ArticleStandard/Article/detail/557365?ref=25 Rep. John D. Dingell (D-MI), chairman of the US House of Representatives Committee on Energy and Commerce, and Rep. Bart Stupak (D-MI), the chairman of the Oversight and Investigations Subcommittee, sent a letter to the US Department of Health and Human Services (HHS), questioning the US Food and Drug Administration?s use of agency resources to hire an outside public-relations firm to create a positive public image of the agency. 2008-10-09T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412008/557365null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/Lilly-to-Acquire-ImClone-for-65-billion/ArticleStandard/Article/detail/557373?ref=25 Under a definitive merger agreement, Eli Lilly and Company will acquire ImClone Systems, Inc. (New York) in a cash tender offer of approximately $6.5 billion. 2008-10-09T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412008/557373null HTML http://pharmtech.findpharma.com/pharmtech/iSourcing-and-Managementi-Launches-Community-of-Ex/ArticleStandard/Article/detail/552063?ref=25 Leading professionals join the community of experts panel of Sourcing and Management. 2008-10-08T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/392008/552063null HTML http://pharmtech.findpharma.com/pharmtech/Outsourcing+Outlook/Big-Deals/ArticleStandard/Article/detail/552070?ref=25 Summer deals struck by Novartis and Lilly point to an evolution in contract services. 2008-10-08T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/392008/552070null XML http://pharmtech.findpharma.com/pharmtech/REACHs-Impact-on-the-Pharmaceutical-Industry/ArticleStandard/Article/detail/552045?ref=25 The pharmaceutical industry faces compliance with the REACH regulation, the European Union's regulation on chemicals and their safe use. Fully understanding the requirements, achieving compliance, and developing strategies for working with suppliers are key for avoiding interruption of the supply chain. 2008-10-08T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/392008/552045null HTML http://pharmtech.findpharma.com/pharmtech/Ricerca-Biosciences-in-Expansion-Mode/ArticleStandard/Article/detail/552068?ref=25 Buoyed by increased demand for pharmaceutical outsourcing services, Ricerca Biosciences proceeds with an expansion plan. 2008-10-08T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/392008/552068null HTML http://pharmtech.findpharma.com/pharmtech/IT/Integration-the-Easy-Way/ArticleStandard/Article/detail/557195?ref=25 Pharmaceutical companies want software vendors to make integrating manufacturing execution systems and enterprise resource planning systems easier. 2008-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412008/557195/onlineEX_main.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412008/557195null XML http://pharmtech.findpharma.com/pharmtech/IT/Complex-Science/ArticleStandard/Article/detail/557180?ref=25 Advancements add yet another challenge for industry's already overextended regulatory body. 2008-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412008/557180null XML http://pharmtech.findpharma.com/pharmtech/Regulation+Article/Are-You-Ready-for-REMS/ArticleStandard/Article/detail/557194?ref=25 A book offers a detailed introduction to the new area of risk evaluation and mitigation strategies. 2008-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412008/557194/onlineEX_main.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412008/557194null XML http://pharmtech.findpharma.com/pharmtech/IT/Pharma-Capsules/ArticleStandard/Article/detail/557192?ref=25 Brief pharmaceutical news items for October 2008. 2008-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412008/557192null XML http://pharmtech.findpharma.com/pharmtech/Ingredients/Effect-of-Binder-Type-and-Binder-Level-on-the-Prop/ArticleStandard/Article/detail/557187?ref=25 The authors studied the effect of the combination of binders on the flow and compressibility characteristics of the agglomerates of binary combination of lactose and dibasic calcium phosphate dihydrate. 2008-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412008/557187null XML http://pharmtech.findpharma.com/pharmtech/Outsourcing+Outlook/Minding-Your-Ps-and-Qs/ArticleStandard/Article/detail/557191?ref=25 As offshore savings decline, pharmaceutical companies still have a lot of work to do to reduce costs. 2008-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412008/557191null XML