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International Journal
of Drug Development

JOURNAL SUBSCRIBERS

International .Journal of :
Generic Drugs
Drug Development
Drug R&D
Drug Formulation
Generic Form & Process
Drug cGMP
Drug Process Validation

Generic Registration


Editorial
Information
Vol.E1 Index 1996
Vol.E2 Index 1997
Vol.E3 Index 1998
Vol.E4 Index 1999
Vol.00 Index 2000
Vol.01 Index 2001
Vol.02 Index 2002
Vol.03 Index 2003
Vol.04 Index 2004
Vol.05 Index 2005
Vol.07 Index 2007
Vol.08 Index 2008
Vol.09 Index 2009
Vol.10 Index 2010
Vol.11 Index 2011
Vol.12 Index 2012-2013
Editorial Board
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The IAGIM Catalog

 

The Int. Journal Series
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 Information

International Journal of Drug Development

A forward looking peer reviewed journal that is relevant from the bench to the boardroom. Addresses the most up-to-date developments in CMC technology. An essential first read for drug development chemists and scientists working in CMCs area of NDAs and ANDAs. An excellent source of know-how information on the nuts-and-bolts of drug development.

Keep informed of the important regulations FDA will adopt this year so you can plan your drug development and manufacturing operations ahead of time.

Learn what the FDA inspectors expect you to do to get new drug product approved quickly. Keep on top of all trends related to the chemistry, manufacturing and controls in the drug development and manufacturing areas.

Stay current on PAI know-how, new regulations FDA is adopting this year and important changes to GMP regulations affecting your drug development and pivotal manufacture.

Model cleaning validation, process validation and analytical validation protocols and plans that have passed successful PAI reviews.

The Journal will save your sales division tens of thousands on lost sales by eradicating long CMC approval times with the Agency.

The Journal will speedup approval faster and reduce agency times by eradicating universal NDA-CMC / ANDA pitfalls.

The Journal dissects and analyzes common and unusual drug development and file submission faults and tell you how these hazards can be avoided to achieve a speedier and less expensive approval.

Subscribe to the Journal and we guarantee it will help you complete drug development faster, cheaper and almost error free with the FDAs regulators blessings.

The International Journal of Drug Development
Designed for pharmaceutical researchers in the NDA CMC (chemistry manufacture control) and Generic Drug Development sectors including detailed aspects of NDA/ANDA (bio/pivotal) and commercial validation batch manufacture. Reviews key CMC processes and products.

Regulatory know-how
Key know-how on CDER and OGDs expectations of the bio/pivotal batch manufacture highlighting side-by-side batch comparisons between bio/pivotal regulatory batch and commercial validation batches.

Full coverage
A comprehensive new forum filled with essential drug development data associated with CMC and on Generic Drug Development, manufacture, quality assurance and control.

Each issue targets a specific dosage form detailing developmental and scale-up topics. Each Journal issue contains material dedicated to the review of a specific dosage form and specific development and scale-up topics.

This Journal features drug development articles, technical reviews, procedural checklists, SOPs and Side-by-Side specification comparisons of all major dosage form parameters ranging from A (actives) to V (validation).

A primary source Journal to fill the ever changing information gap for CMC and Generic Drug Development. The Journal emphasizes a multidisciplinary approach between all key development and production departments.



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