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LOCUM INT. PRESS
Standard & Advanced Edition # and Pub. Year

H/B Vol 10 -2010
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H/B Vol 17-2017
H/B Vol 18-2018
H/B Vol 19-2019

New Edition Annually
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Handbook Generic Development
Oral IR & Chew Tablets
A Two Part Development Handbook

Locum International Press.

Volume 21 (Development volume in Two Parts)
24 Volume Drug Development Series

This Handbook of Pharmaceutical Generic Development is a practical hand-on workbook covering the essential key aspects on development for single dose Oral IR and Chew Tablets. It promotes the development and sharing of practical drug development knowledge and solid dose technology from government agency and industry experts alike.

Designed to specifically eliminate the potential risks and process omissions in drug development and claimed as the world's most authoritative and definitive work available on oral dosage form drug development from a generic industry viewpoint.

SEAMLESS INTEGRATION
An Essential Reference for Development Pharmacists, R&D Chemists, QA/QC and Regulatory personnel. Each and every document, protocol and procedure in Part I + II is expertly referenced to the appropriate module number in the CTD / e-CTD system thus providing a fully seamless and effortless integration into either US, EU and Asian application files and dossier. All IAGIM technology is purposely and uniquely dove-tailed in regulatory drug product applications -worldwide appliations made simple and precise.

Complete development know-how and common error erdication c overs pharmaceutical drug development provide current know-how for the development, formulation, dissolution tips and traps, scale-up, process qualification; stability, pivotal and final validation batches; analytical, cleaning and process validation; critical documentation and OGD regulatory know-how that is essential for a first time successful review for a FDA approval, saving queue-time and market sales.

Essential development and submission know-how on Immediate Release Oral Tablets for professional developers to understand the nuts-and-bolts on generic ANDA DEVELOPMENT with a high-tech detailed integrated development ANDA for quick approval of ANDA files

Specific Additional Titles IR and Chew Tablets Available:- Bupropion, Buspirone, Diclofenac, Famotidine, Felodipine, Nabumetone, Naproxin, Piroxicam, Tamoxifen, Ticlopidine, Trazodone plus other titles.

Complete Volume ~1800 pp fully illustrated with diagrams, graphs, tables in b/w & color. Available on the web and in print (soft or spiral cover) or via CD ROM.

ISBN: 0793-8632 / 0793-8640

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Price: Locum International Catalog

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