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Technical Forum: Disposable Chromatography
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| By
Amy Ritter
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PharmTech spoke with industry experts about the challenges of implementing disposable chromatography systems.
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Applying Quality by Design for Extended Release Hydrophilic Matrix Tablets
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| By
Ian A. Robertson
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Sandip B. Tiwari
,
Tim D. Cabelka
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This study examines the effect and interaction of variations in hypromellose physicochemical properties.
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Supplier Qualification
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Darcy Ewalt
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Tracy L. Cooper
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Frithjof Holtz
,
Irwin Silverstein, PhD
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This article provides a comparison of Rx-360, EXCiPACT and IPEA, available to pharmaceutical manufacturers for the purpose of auditing excipient suppliers and ensuring drug efficacy and patient safety.
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Early Development GMPs for Small-Molecule Specificiations: An Industry Perspective (Part V)
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| By
Michael Coutant
,
Zhihong Ge
,
James S. McElvain
,
Scott A. Miller
,
Dennis O'Connor
,
Frank Swanek
,
Michael Szulc
,
Mark D. Trone
,
Kirby Wong-Moon
,
Mehran Yazdanian
,
Peter Yehl
,
Shuhong Zhang
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IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development.
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A World without R&D
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| By
Angie Drakulich
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Will the next US President support the backbone of our industry?
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Report from India
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| By
Jane Wan
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Foreign firms struggle against stricter patent laws, but all is not lost.
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Regulation and Compliance Q&A on 483s
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Q&A with David Elder and Richard Wright of Strategic Compliance Consulting, PAREXEL International. Both Elder and Wright formerly served with FDA.
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Case Closed
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| By
Control, a senior compliance officer
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Only the strong survive when it comes to pharmaceutical packaging and shipping.
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In the Spotlight
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New product reviews for October 2012, featuring analytical equipment.
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New Era for Generic Drugs
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| By
Jill Wechsler
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The promise of the Generic Drug User Fee Amendments of 2012 is to end multiyear reviews of new generic drugs and the ever-growing queue of pending applications.
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Shifts in Pharma Capital Agendas
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| By
Andrew Forman
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The long-awaited patent cliff that has loomed in the pharmaceutical industry for years has arrived in earnest in 2012, with more than $40 billion in 2011 brand sales facing loss of exclusivity.
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Determining Potency of Preclinical Dose Formulations
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| By
Ashley Sanchez
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Melissa Whitsel
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Amy Smith
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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.
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FDA and the Importance of Confidentiality
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| By
David L. Rosen
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Recent news stories have reported that FDA scientists have been suspected of leaking confidential, commercial, and trade secret information to the media.
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