Pharmaceutical Technology, Oct 2, 2009 - Pharmaceutical Technology

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Pharmaceutical Technology, Oct 2, 2009
Online Exclusives
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 , 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.
Special Report
Getting the Truth out of Dissolution Testing
By Maribel Rios
Industry, equipment vendors, and regulators are busy refining the precision and reliability of dissolution testing.
The Emerging Markets of the East
By Angie Drakulich
The countries of Central and Eastern Europe and the Commonwealth of Independent States are closing in on global pharmaceutical competition.
Peer-Reviewed Research
Formulation and Evaluation of Famotidine Floating Matrix Tablets
By J.A. Raval , M.M. Patel , Nai-Hong Li , J.K. Patel
The authors investigated the effects of formulation and processing parameters on floating matrix-controlled drug-delivery systems.
Verification Methods for 198 Common Raw Materials Using a Handheld Raman Spectrometer
By Robert L. Green , Robert Brush , Wayne Jalenak , Christopher D. Brown
Using handheld Raman spectroscopy, methods were developed and evaluated for 198 substances widely used as raw materials.
Special Section: Quality by Design
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 , Stephen P. Simmons , Nirdosh Jagota , Donald G. Esherick , 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 , Robert Lionberger , Michael C. Olson , Gordon Johnston , Gary Buehler , 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.
Ingredients Insider
Delivering the Results in Drug-Based Nanotechnology
By Patricia Van Arnum
New nanotechnology-based delivery systems offer promise in drug delivery, particularly for anticancer therapeutics.
Outsourcing Outlook
Sizing Up the CDMO Market
By Jim Miller
A new analysis highlights growth drivers and challenges for clinical supply-chain services.
Washington Report
New Leadership Seeks to Transform FDA
By Jill Wechsler
Strict enforcement, new rules, and organizational changes signal an activist tone.
Agent-In-Place
Sneaky and Suspicious
By Control, a senior compliance officer
Like life, the workplace also can have many surprises.
Articles
Technical Note: The Case for Supplier Qualification
By Irwin Silverstein, PhD
This article demonstrates that test results support the position of FDA on the importance of an appropriate supplier-qualification program.
Guest Editorial
Looking Ahead: The Pharmaceutical-Science Industry
By Patrick P. DeLuca
AAPS President offers hope and solutions for the industry's challenging future.
PhRMA's Stake in Reform
By Billy Tauzin
The nation's healtcare system needs an overhaul, but it has to be done right.
Statistical Solutions
Statistical Solutions: Square Root of (N) + 1 Sampling Plan
By Lynn D. Torbeck
Is the square root of (N) + 1 a statistically valid scheme?
Inside USP
Inside USP: Characterization of Heparin Products
By Anita Y. Szajek , Tina S. Morris
USP workshop participants support new methods to safeguard heparin products but desire international harmonization. This article contains bonus online-exclusive material.
Viewpoint
Progress Made on the Path to Biosimilars
By James C. Greenwood
BIO supports recent Congressional action toward a 12-year data exclusivity period for innovators.
News
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.
Industry Leaders: Q&A
Stephen Brown of Encap Drug Delivery
Brown discusses the latest industry developments and trends.
Pharma Capsules
Pharma Capsules
Brief pharmaceutical news items for October 2009.
In the Spotlight
In the Spotlight
Editors' Picks of Pharmaceutical Science & Technology Innovations

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