Handbook Generic Development
Oral IR Liquids
A Two Part Development Handbook

Locum International Press

Volume 04 - (Complete Handbook in Two Parts)
of the 24 Volume Drug Development Series.

Handbook of Pharmaceutical Generic Development Series.
Authoritative fully integrated oral liquid handbook clarifying each document required to construct a successful CTD/ANDA 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 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 - ideal for pharmaceutical scientists. It promotes the development and sharing of practical drug development knowledge and liquid dose technology from government agency and industry experts alike.

The world's most authoritative Generic Development know-how with full explanation notes dovetailing side-by-side with agency guidelines

Who this book is for:
This handbook of Pharmaceutical Generic Development is an essential workbook for the full CMC 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 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: 0793-0077 / 0793-0079

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Price: Locum International Catalog

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