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| Packaging Goes Green
| | | By
Hallie Forcinio
| | | Pharmaceutical companies get ideas for sustainable packaging from other industries.
| | | How to Develop a Practical (and Compliant) Vendor Qualification Program
| | | By
Nancy Cafmeyer
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Jonathan M. Lewis
| | | This article introduces the "Q.U.E.S.T." approach for vendor qualification, a practical and compliant methodology for pharmaceutical and biopharmaceutical companies to qualify vendors and hence make well-informed purchasing-related decisions.
| | | CROs and CMOs Go Further East
| | | By
Angie Drakulich
| | | Contract research organizations such as Covance are heading further east through Europe.
| | | Multinational Firms Stake Claims
| | | By
Angie Drakulich
| | | This article is part of a Special Report on the Emerging Markets of The East, October 2009
| | | Standard-Setting Bodies Engage Russia
| | | By
Angie Drakulich
| | | As the pharmaceutical industry moves further into Central and Eastern Europe and the Commonwealth of Independent States, several standard-setting and regulatory bodies are also increasing collaboration in the region, particularly in Russia.
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| Critical Challenges to Implementing QbD: A Q&A with FDA
| | | By
Angie Drakulich
| | | Officials from the US Food and Drug Administration discuss best practices for applying quality-by-design concepts. This article contains bonus online-exclusive material.
| | | Global Regulatory Submissions for QbD: Wyeth's Experience in the CMC Pilot
| | | By
Thirunellai G. Venkateshwaran
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Stephen P. Simmons
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Nirdosh Jagota
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Donald G. Esherick
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Patricia Foti Mann
| | | Representatives of one pilot program participant, Wyeth, outline the experiences and lessons learned for implementing a science- and risk-based approach to drug-development and manufacturing.
| | | Equivalence by Design for Advanced Dosage Forms and Drug Products
| | | By
Mei-Ling Chen
| | | FDA has been encouraging drug sponsors to use a systematic approach such as quality-by-design principles for pharmaceutical development.
| | | The Relevance of Continuous Solid Oral Dosage Processing and NIR Spectroscopy In Meeting the Needs of QbD and PAT
| | | By
Thomas S. Chirkot
| | | The author discusses control strategies via near infrared instrumentation for continuous mixing, granulation, drying, and extrusion with a more focused detail on mixing.
| | | Quality by Design for Generic Drugs
| | | By
Lawrence X. Yu
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Robert Lionberger
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Michael C. Olson
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Gordon Johnston
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Gary Buehler
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Helen Winkle
| | | The authors relay the outcome of a two-day workshop that brought together regulators and generic-drug industry representatives.
| | | Question-Based Review: An FDA Reviewer's Perspective
| | | By
David J. Skanchy
| | | The author analyzes, from an agency perspective, whether question-based review has improved product quality or made the review process easier for regulators or for industry.
| | | Building a Framework for Quality by Design
| | | By
Ronald D. Snee
| | | The author describes the framework needed to implement QbD and achieve the deeper process understanding that is fundamental to QbD.
| | | Academia Tackles QbD Science: NIPTE Carries out FDA Grant and Educational Initiatives
| | | By
Angie Drakulich
| | | A review of NIPTE's core projects and its plans for training-and retraining-the pharmaceutical industry.
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| Sizing Up the CDMO Market
| | | By
Jim Miller
| | | A new analysis highlights growth drivers and challenges for clinical supply-chain services.
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| Sneaky and Suspicious
| | | By
Control, a senior compliance officer
| | | Like life, the workplace also can have many surprises.
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| Inside USP: Characterization of Heparin Products
| | | By
Anita Y. Szajek
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Tina S. Morris
| | | USP workshop participants support new methods to safeguard heparin products but desire international harmonization. This article contains bonus online-exclusive material.
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| Report From: India
| | | By
A. Nair
| | | Pharmaceutical companies in India have had a hold on the biotechnology sector for many years, and they're not about to let the follow-on biologics market pass them by.
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| In the Spotlight
| | | Editors' Picks of Pharmaceutical Science & Technology Innovations
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Speed, Resolution, Reproducibility, Flexibility, Durability: Unmatched in sample throughput & data precision, Shimadzu's Prominence Ultrafast LC (UFLC) delivers data without compromise. Learn more.
Processing & Packaging Online Auction - November 24th, 2009 - 9-4 ET
DJS Enterprises - Since 1991 buying and selling high quality, reasonably priced New, Used and Reconditioned Process and Packaging Equipment for the Pharmaceutical, Vitamin, Food and Confectionery Industries.
Buy new and used pharmaceutical equipment, used process equipment and laboratory equipment at LabX. Auctions, classifieds, and post FREE wanted ads to locate equipment.
Swagelok® DR series valve design saves space, minimizes entrapment, extends diaphragm life. See how.
Applying E-Commerce to Support Discovery and Development of Medicines: Key Lessons and Learnings Tuesday, December 15 @ 11:00 a.m. ET
Million Dollar Biotech & Pharmaceutical Equipment Online Auctions