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 anywhere.
"truly excellent formulation know-how -Teva (on Paracetamol technology)
LOCUM INT. PRESS
Vol, Edition # and Pub. Year.
H/B Vol 4/Ed 14 - 2014
H/B Vol 4/Ed 15 - 2015
H/B Vol 4/Ed 16 - 2016
H/B Vol 4/Ed 17 - 2017
H/B Vol 4/Ed 18 - 2018
H/B Vol 4/Ed 19 - 2019
H/B Vol 4/Ed 20 - 2020
New Edition Annually.
Locum Publishers Clients
(Handbooks and Journals
Handbook Generic Development
Oral IR Liquids
Two Part Development To Final Production Handbook
Locum International Press
Volume 4 - (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
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
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
Allows management to understand the nuts and bolts on Generic development
and filing in the most cost effective way. A complete training model for
Development pharmacists, R&D chemists and scientists in pharmaceutical
companies and university departments, in the areas of innovative, new
drugs and generic drug development, QA / QC. validation and regulatory
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)
0793-0077 / 0793-0079
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