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Packaging Goes Green
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| By
Hallie Forcinio
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Pharmaceutical companies get ideas for sustainable packaging from other industries.
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How to Develop a Practical (and Compliant) Vendor Qualification Program
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| By
Nancy Cafmeyer
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Jonathan M. Lewis
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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.
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CROs and CMOs Go Further East
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| By
Angie Drakulich
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Contract research organizations such as Covance are heading further east through Europe.
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Multinational Firms Stake Claims
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| By
Angie Drakulich
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This article is part of a Special Report on the Emerging Markets of The East, October 2009
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Standard-Setting Bodies Engage Russia
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| By
Angie Drakulich
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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
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| By
Angie Drakulich
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Officials from the US Food and Drug Administration discuss best practices for applying quality-by-design concepts. This article contains bonus online-exclusive material.
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Global Regulatory Submissions for QbD: Wyeth's Experience in the CMC Pilot
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| 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
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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.
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Equivalence by Design for Advanced Dosage Forms and Drug Products
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| By
Mei-Ling Chen
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FDA has been encouraging drug sponsors to use a systematic approach such as quality-by-design principles for pharmaceutical development.
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The Relevance of Continuous Solid Oral Dosage Processing and NIR Spectroscopy In Meeting the Needs of QbD and PAT
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Thomas S. Chirkot
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The author discusses control strategies via near infrared instrumentation for continuous mixing, granulation, drying, and extrusion with a more focused detail on mixing.
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Quality by Design for Generic Drugs
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| 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
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The authors relay the outcome of a two-day workshop that brought together regulators and generic-drug industry representatives.
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Question-Based Review: An FDA Reviewer's Perspective
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David J. Skanchy
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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.
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Building a Framework for Quality by Design
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Ronald D. Snee
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The author describes the framework needed to implement QbD and achieve the deeper process understanding that is fundamental to QbD.
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Academia Tackles QbD Science: NIPTE Carries out FDA Grant and Educational Initiatives
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| By
Angie Drakulich
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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
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| By
Jim Miller
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A new analysis highlights growth drivers and challenges for clinical supply-chain services.
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Sneaky and Suspicious
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| By
Control, a senior compliance officer
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Like life, the workplace also can have many surprises.
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Inside USP: Characterization of Heparin Products
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| By
Anita Y. Szajek
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Tina S. Morris
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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
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| By
A. Nair
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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
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Editors' Picks of Pharmaceutical Science & Technology Innovations
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