The world's most definitive & authoritative current generic drug development
"No R&D development unit should be without it - Pliva"
"Our R&D really used this series publication" - Berlex.
LOCUM INT. PRESS
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
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
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
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)
965 492 004-2 / ISBN 965492005-0
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