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
"No development unit should be without it -Pliva"
"packed with know-how and very useful protocols...
LOCUM INT. PRESS
Vol, Edition # and Pub. Year.
H/B Vol 10/Ed 18 - 2018
H/B Vol 10/Ed 19 - 2019
H/B Vol 10/Ed 20 - 2020
H/B Vol 10/Ed 21 - 2021
H/B Vol 10/Ed 22 - 2022
H/B Vol 10/Ed 23 - 2023
H/B Vol 10/Ed 24 - 2024
New Updated Edition Annually
Handbook Generic Development
Two Part Development To Final Production Handbook
Locum International Press
Volume 10 -
(Complete Handbook in Two Parts)
of the International 24 Volume Drug Development Series
Handbook of Pharmaceutical Generic Development is a fully comprehensive
practical hands-on workbook covering modern drug development and the full
CTD/eCTD section interactions of a Extended or Modified Controlled Release
Oral Tablet or Caplet. Table of Contents for both US and EU eCTD and CTD
Handbook volume provides an
outstanding authoritative and definative reference for critical documentation
(including updated patent and exclusivity information) and OGD regulatory
know-how that is essential for a successful first time review and agency
approval, saving months of queue-time and market place sales.
Each and every regulatory guideline is covered in clear detail providing
a development protocol for a totally omission-free file submission.
Designed to specifically eliminate the potential risks and common process
omissions that occur during the drug development and validation process.
Widely claimed as the world's most authoritative and definitive work available
on specific dosage form drug development from a both a generic and innovative
An essential reference for development pharmacists, R&D Chemists, QA/QC
and regulatory personnel.
Allows management to fully understand the nuts and bolts on Generic ANDA
development and filing and how to get to the market place - quickly and
Volume in two parts 1890-2000 pp. Part 1 and 2 fully illustrated and annotated
with diagrams, flow charts, formula, graphs, spectra, side-by-side comparisons,
tables in b/w & color. Available in print (spiral soft cover opens
flat) or via digital CD (multi-users require additinal optional license).
Split volume attract a 25% handling and broken volume charge to split
the two part volume.
0793-8772 / 0793-8780
Price go to : Locum
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