Handbook Generic Development
Oral DR Tablets
A Two Part Development Handbook

Locum International Press.

Volume 12 - (Complete Handbook in Two Parts)
of the 24 Volume Drug Development Series

This Handbook of Pharmaceutical Generic Development is a practical hands-on workbook covering state-of-the-art development for the full ANDA development sections required for a Oral DR Tablet (Spay Granulation Enteric Coated Delayed Release). Table of Contents for both US and EU eCTD and CTD modules.

Part Two (Technical ANDA Development) provide practical key documentation and OGD regulatory know-how that is essential for a successful review for a FDA approval, saving queue-time and money.

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.
An Essential Reference for Development Pharmacists, R&D Chemists, QA/QC and Regulatory personnel.

Master Formula and detailed step-by-step processes are current US and EU commercial generic drug product leaders. Essential development and submission know-how on Delayed Release Oral Tablets for professional generic developers to understand the nuts-and-bolts on Generic ANDA development with a high-tech detailed working commercial ANDA know-how for quick approval of ANDA files.

Complete Volume 800-850 pp for Part 1 and 2 fully illustrated with diagrams, graphs, tables in b/w & color

ISSN: 0793-7456 / 0793-7764

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