Print Edition

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.

"No R&D development unit should be without it - Pliva"

"Our R&D really used this series publication" - Berlex.

Vol, Edition # and Pub. Year.

H/B Vol 7/Ed 18 - 2018
H/B Vol 7/Ed 19 - 2019
H/B Vol 7/Ed 20 - 2020
H/B Vol 7/Ed 21 - 2021
H/B Vol 7/Ed 22 - 2022
H/B Vol 7/Ed 23 - 2023
H/B Vol 7/Ed 24 - 2024

New Updated Edition Annually

Locum Publishers Clients
(Handbooks and Journals

Handbook Generic Development
Oral IR Suspensions

A Two Part Development To Final Production Handbook

Locum International Press

Volume 7 - (Complete Handbook in Two Parts)
of the 24 Volume Drug Development Series.

The Handbook of Pharmaceutical Generic Development is an essential workbook covering the full CMC/CTD & Bio and RA sections of normal Oral Suspension and Suspension for Reconstitution.

Part One with detailed commercial and state-of-the-art formula provides essential know-how technology on all aspects of; Development, Formulation, Dissolution, Stability Scale-up, Process Optimization & Qualification; Pivotal and large scale Validation batches; Analytical, cleaning and process validation; essential documentation and OGD regulatory know-how that is essential for a successful review for a FDA approval, saving queue-time and money.

An Essential Reference for Development Pharmacists, R&D Chemists, QA/QC and Regulatory personnel. Each and every document, protocol and procedure in Part I + II is expertly referenced to the appropriate module number in the CTD / e-CTD system thus providing a fully seamless and effortless integration into either US, EU and Asian application files and dossier. All IAGIM technology is purposely and uniquely dove-tailed in regulatory drug product applications -worldwide appliations made simple and precise.

Over five years in preparation and claimed as the world's most authoritative and definitive work available on oral dosage form drug development from a generic industry viewpoint. An Essential Reference for Development Pharmacists, R&D Chemists, QA/QC and Regulatory personnel.

Key development know-how on Oral Suspensions and Suspensions for Reconstitution directed to professional developers to understand the nuts-and-bolts on Generic ANDA Development to produce flawless files

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 965 492 004-2 / ISBN 965492005-0

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