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Promotes the development and sharing of practical drug development knowledge and technology by agency and industry experts alike.

The world's most definitive & authoritative current generic drug development series available.

"covers the entire FDA and OGD requirements and expectations and more
-Rhone-Polenc-Rorer"

".very successful ANDAs
achieved with this knowhow" - KRKA.

LOCUM INT. PRESS
Vol, Edition # and Pub. Year.

H/B Vol 12/Ed 14 - 2014
H/B Vol 12/Ed 15 - 2015
H/B Vol 12/Ed 16 - 2016
H/B Vol 12/Ed 17 - 2017
H/B Vol 12/Ed 18 - 2018
H/B Vol 12/Ed 19 - 2019
H/B Vol 12/Ed 20 - 2020

New Edition Annually

 

Handbook Generic Development
Oral DR Tablets
A Two Part Development To Final Production 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 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

All air shipping is 100% insured for loss or replacement. Shipping rates are | Standard | Priority | Expedited.


Price go to: Locum International Catalog



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