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 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

A 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.
A
uthoritative 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.

Readership
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 personnel.

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

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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