Handbook Generic Development
Semisolids Topical
A Two Part Development Handbook

Locum International Press

Volume 03 - (Complete Handbook in Two Parts)
of the 24 Volume Drug Development Series.

Handbook of Pharmaceutical Generic Development Series.
Authoritative and advanced development of a semisolids topical with side-by-side explanation notes and lists of development do's and don'ts for fast track product development. TOC for US and EU eCTD and CTD.

Explains how to convert ANDAs to EC format and how to build a fault-free global regulatory file from pre-formulation to final submission. Edition Handbook devoted to Generic Drug Development from pre-formulation to regulatory submission and first commercial batch production.

Written in two user-friendly complementary handbooks (Part I & II), with a unique modular format and data layout formula excipients checklists and validation protocols of all types- ideal for pharmaceutical scientists.

The world's most authoritative ANDA Development know-how with full explanation notes dovetailing side-by-side with Part One.
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Who this book is for:
This handbook of Pharmaceutical Generic Development is an essential workbook for the full CMS development and all RA sections of a fault free ANDA. Essential reading for Development Pharmacists, R&D Chemists, QA and Regulatory personnel.

Allows management to understand the nuts and bolts on Generic ANDA development and filing in the most cost effective way. A complete training model for pharmaceutical graduates.

Complete Volume in two parts 1690-1850 pp. Part 1 and 2 fully illustrated with diagrams, flow charts, graphs, side-by-side comparisons, tables in b/w & color. Available in print (spiral soft cover) or (via digital CD multi-users require additinal optional license)

ISBN: 0793-2012 / 0793-2015

Price: Locum International Catalog

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