Available: Print or CD
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.
"Thanks - a superb book "-
-Nortons-Ivax
The drug development series made us rethink
our development techniques - Lek dd.
"No development unit should be without it
-Pliva"
LOCUM INT. PRESS
Standard & Advanced Edition # and Pub. Year
H/B Vol 10 -2010
H/B Vol 11 -2011
H/B Vol 12 -2012
H/B Vol 13-2013
H/B Vol 14-2014
H/B Vol 15-2015
H/B Vol 16-2016
H/B Vol 17-2017
H/B Vol 18-2018
H/B Vol 19-2019
New Edition Annually
Print or electronic. Licenced or unlicenced.
Printable or read only e-editions.
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Handbook Generic Development
Oral IR &
Chew Tablets
A
Two Part Development Handbook
Locum International Press.
Volume 21 (Development
Volume in Two Parts)
24 Volume Drug Development Series
This Handbook of Pharmaceutical Generic Development is a practical
hand-on workbook covering the essential aspects on the drug development
for single dose Oral Tablets. It promotes the development and sharing
of practical drug development knowledge and solid dose technology from
government agency and industry experts alike. Table of Contents for
both US and EU eCTD and CTD modules.
Each product specific handbook focuses exclusively on single dosage
form and in essence informs and guides the product developer (a) what
exactly must be done (b) once it is completed how to write and format
the raw data (c) what the agency expects to see in each section and
(d) what the developer must not leave out.
Each and every agency guideline and development requirement is thoroughly
dealt with in a step-by-step manner in order to avoid the pitfalls occurring
during product development. Includes all ANDA forms and Guidelines on
CD
SEAMLESS
INTEGRATION
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.
Essential development and submission know-how on immediate release
Oral Tablets for professional developers to understand the nuts-and-bolts
on Generic ANDA Development with a high-tech detailed integrated development
ANDA know-how for quick approval of ANDA files.
Specific Additional Titles Available: - Bupropion, Buspirone, Diclofenac,
Famotidine, Felodipine, Nabumetone, Naproxin, Piroxicam, Tamoxifen,
Ticlopidine, Trazodone plus other titles.
Complete Volume ~1800 pp fully
illustrated with diagrams,
graphs, tables in b/w & color.
Available on the web and
in print (soft or spiral cover)
or via CD ROM.
ISBN: 0793-8632
/ 0793-8640
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International Catalog
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