Pharmaceutical Technology-09-02-2007

Pharmaceutical Technology

Supplements to the PQRI Workshop Results

September 02, 2007

Online Exclusives

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Appendix: definitions and regulations, Federal Food, Drug, and Cosmetic Act; Appendix: definitions and regulations, Title 21 Code of Federal Regulations; Appendix: definitions and regulations, Compliance Policy Guides

Pharma Capsules

September 02, 2007

Pharma Capsules

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News and Views

The Challenges and Opportunities in ICH Q10

September 02, 2007

Online Exclusives

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Jason Kamm, managing consultant with Tunnell Consulting discusses the challenges and opportunities for pharmaceutical manufacturers in ICH Q10, the draft guidance on pharmaceutical quality systems issued by the International Conference on Harmonization.

Revolution in Progress

September 02, 2007

Articles

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How the Indian pharmaceutical sector is reinventing itself

Profiles in Biotechnology, Standards, Machinery, Innovation, Global Know-how, Strategies, and Expansion

September 02, 2007

Articles

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In a nation of more than 1 billion people, the importance of vaccines goes beyond healthcare-it is a matter of national security. Armed with this belief and a philanthropic vision that most Indians could be protected against hepatitis, DT–Polio, and other afflictions, Dr. Varaprasad Reddy entered the nascent Indian biotechnology sector in 1992 and has since managed to threaten the monopoly of large laboratories. That year, the Hepatitis B vaccine cost $33 per shot, and yet some families were subsisting on less than $1 a day. Meanwhile, India was importing only 180,000 doses per year.

Useful Contacts

September 02, 2007

Articles

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Useful Contacts

Joint Position Paper on Pharmaceutical Excipient Testing and Control Strategies

September 02, 2007

Articles

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This article presents collaborative positions among excipient manufacturers, drug product manufacturers, and members of the US Pharmacopeia on key issues pertaining to the control of pharmaceutical excipients stemming from a recent Pharmaceutical Quality Research Institute workshop.

Let's Get Publishing

September 02, 2007

This Time Around

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When it comes to research, the United States scientific community is still way ahead of the game, but we're not sharing our findings as often as we should. According to a new National Science Foundation (NSF) report, the number of science and engineering articles by US-based authors published in major peer-reviewed journals has plateaued.

In The Field

September 02, 2007

In the Field

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US and China Crack Down on Regulation after SFDA Chief Executed; Xcellerex Receives US Grant for Biopharmaceutical Production; New FDA Guidance on Polymorphic Compounds in Generic Drugs; Comment Periods Open for ICH Q10 and Biologics Guidelines