Pharmaceutical Technology, Aug 1, 2007 - Pharmaceutical Technology

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Pharmaceutical Technology, Aug 1, 2007
Articles
Evaluating Supply and Demand Patterns for Contract Biologics Manufacturing
By William Downey , Lynne Sopchak
The authors analyze the supply–demand trends for contract biologics manufacturing and the strategies of pharmaceutical and biotechnology companies and their suppliers in the value chain.
Project Management and CMO–Sponsor Relations
By Sandra A. Lueken
Using basic project management tools and ideas in the transfer process saves time and money and ensures high success rates.
Preparing Documentation to Support Clinical Supply Manufacture
By Peggy A. Krotzer
This article is written to assist clinical manufacturing representatives at pharmaceutical companies who are faced for the first time with outsourcing the manufacture of clinical supplies. The author describes the identification, writing, and execution of documents required to support the contract manufacture of products for clinical studies.
The Role of Risk Analysis in Expanding Business Activities
By Maurizio Battistini
Risk management is essential in any successful outsourcing partnership. The author outlines the steps toward identifying, understanding, and controlling risk in key manufacturing areas.
Dynamics of India's Life Sciences Outsourcing Industry
By Nailesh A. Bhatt
The tightening of intellectual property rights in India under GATT/TRIPS was a crucial inflection point for pharmaceutical outsourcing in India.
Recovery of Precious Metals in Spent Process Catalysts
By Kevin Beirne
Catalysts are important tools in the synthesis of active pharmaceutical ingredients. Recovery of precious-metal catalysts from a pharmaceutical manufacturing process is a factor in cost control and environmental compliance.
Strong Demand versus Strained Capacity
By Jim Miller
A booming market may be stressing the service-delivery system.
From The Editor
From Boon to Bubble?
By Michelle Hoffman
Infrastructure must be in place before jumping into outsourcing.

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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
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More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
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