IAGIM - Drug Development Association

Available: Print

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.

"very satisfactory - a truly excellent series"- LEK dd.

"the most comprehensive reference works in our research library" - KRKA.

Vol, Edition # and Pub. Year.

H/B Vol 3/Ed 19 - 2019
H/B Vol 3/Ed 20 - 2020
H/B Vol 3/Ed 21 - 2021
H/B Vol 3/Ed 22 - 2022
H/B Vol 3/Ed 23 - 2023
H/B Vol 3/Ed 24 - 2024
H/B Vol 3/Ed 25 - 2025

New Updated Edition Annually.

Locum Publishers Clients
(Handbooks and Journals

Handbook Generic Development
Semisolids Topical

A Two Part Development Handbook
Creams / Gels / Ointments

Locum International Press

Volume 3 - (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.
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 2000 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 Go to: Locum International Catalog

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