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Pharmaceutical Technology-10-02-2009
Pharmaceutical Technology
Pharmaceutical Technology, October 2009 Issue (PDF)
October 02, 2009
Issue PDF
33
10
Getting the Truth Out of Dissolution Testing
Looking Ahead: The Pharmaceutical-Science Industry
October 02, 2009
Guest Editorial
33
10
AAPS President offers hope and solutions for the industry's challenging future.
Statistical Solutions: Square Root of (N) + 1 Sampling Plan
October 02, 2009
Statistical Solutions
33
10
Is the square root of (N) + 1 a statistically valid scheme?
Formulation and Evaluation of Famotidine Floating Matrix Tablets
October 02, 2009
Peer-Reviewed Research
33
10
The authors investigated the effects of formulation and processing parameters on floating matrix-controlled drug-delivery systems.
Report From: India
October 02, 2009
News
33
10
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.
The Emerging Markets of the East
October 02, 2009
Special Report
33
10
The countries of Central and Eastern Europe and the Commonwealth of Independent States are closing in on global pharmaceutical competition.
New Leadership Seeks to Transform FDA
October 02, 2009
Washington Report
33
10
Strict enforcement, new rules, and organizational changes signal an activist tone.
Quality by Design for Generic Drugs
October 02, 2009
Special Section: Quality by Design
33
10
The authors relay the outcome of a two-day workshop that brought together regulators and generic-drug industry representatives.
Getting the Truth out of Dissolution Testing
October 02, 2009
Special Report
33
10
Industry, equipment vendors, and regulators are busy refining the precision and reliability of dissolution testing.
Technical Note: The Case for Supplier Qualification
October 02, 2009
Articles
33
10
This article demonstrates that test results support the position of FDA on the importance of an appropriate supplier-qualification program.
Verification Methods for 198 Common Raw Materials Using a Handheld Raman Spectrometer
October 02, 2009
Peer-Reviewed Research
33
10
Using handheld Raman spectroscopy, methods were developed and evaluated for 198 substances widely used as raw materials.
Progress Made on the Path to Biosimilars
October 02, 2009
Viewpoint
33
10
BIO supports recent Congressional action toward a 12-year data exclusivity period for innovators.
PhRMA's Stake in Reform
October 02, 2009
Guest Editorial
33
10
The nation's healtcare system needs an overhaul, but it has to be done right.
Sneaky and Suspicious
October 02, 2009
Agent-In-Place
33
10
Like life, the workplace also can have many surprises.
In the Spotlight October 2009
October 02, 2009
In the Spotlight
33
10
Editors' Picks of Pharmaceutical Science & Technology Innovations
Delivering the Results in Drug-Based Nanotechnology
October 02, 2009
Ingredients Insider
33
10
New nanotechnology-based delivery systems offer promise in drug delivery, particularly for anticancer therapeutics.
Equivalence by Design for Advanced Dosage Forms and Drug Products
October 02, 2009
Special Section: Quality by Design
33
10
FDA has been encouraging drug sponsors to use a systematic approach such as quality-by-design principles for pharmaceutical development.
Global Regulatory Submissions for QbD: Wyeth's Experience in the CMC Pilot
October 02, 2009
Special Section: Quality by Design
33
10
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.
Sizing Up the CDMO Market
October 02, 2009
Outsourcing Outlook
33
10
A new analysis highlights growth drivers and challenges for clinical supply-chain services.
The Relevance of Continuous Solid Oral Dosage Processing and NIR Spectroscopy In Meeting the Needs of QbD and PAT
October 02, 2009
Special Section: Quality by Design
33
10
The author discusses control strategies via near infrared instrumentation for continuous mixing, granulation, drying, and extrusion with a more focused detail on mixing.
Critical Challenges to Implementing QbD: A Q&A with FDA
October 02, 2009
Special Section: Quality by Design
33
10
Officials from the US Food and Drug Administration discuss best practices for applying quality-by-design concepts. This article contains bonus online-exclusive material.
CROs and CMOs Go Further East
October 02, 2009
Online Exclusives
33
10
Contract research organizations such as Covance are heading further east through Europe.
Inside USP: Characterization of Heparin Products
October 02, 2009
Inside USP
33
10
USP workshop participants support new methods to safeguard heparin products but desire international harmonization. This article contains bonus online-exclusive material.
Academia Tackles QbD Science: NIPTE Carries out FDA Grant and Educational Initiatives
October 02, 2009
Special Section: Quality by Design
33
10
A review of NIPTE's core projects and its plans for training-and retraining-the pharmaceutical industry.
How to Develop a Practical (and Compliant) Vendor Qualification Program
October 02, 2009
Online Exclusives
33
10
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.
Standard-Setting Bodies Engage Russia
October 02, 2009
Online Exclusives
33
10
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.
Building a Framework for Quality by Design
October 02, 2009
Special Section: Quality by Design
33
10
The author describes the framework needed to implement QbD and achieve the deeper process understanding that is fundamental to QbD.
Multinational Firms Stake Claims
October 02, 2009
Online Exclusives
33
10
This article is part of a Special Report on the Emerging Markets of The East, October 2009
Packaging Goes Green
October 02, 2009
Online Exclusives
33
10
Pharmaceutical companies get ideas for sustainable packaging from other industries.
Q&A with Stephen Brown, Chief Operating Officer of Encap Drug Delivery
October 02, 2009
Industry Leaders: Q&A
33
10
Brown discusses the latest industry developments and trends.
Question-Based Review: An FDA Reviewer's Perspective
October 02, 2009
Special Section: Quality by Design
33
10
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.