Promotes the development and sharing of practical
drug development knowledge and technology by agency and industry experts
The world's most definitive & authoritative current generic drug
development series available.
"Thanks - a superb book "-
The drug development series
made us rethink our development techniques - Lek
"No development unit should be without it
LOCUM INT. PRESS
Vol, Edition # and Pub. Year.
H/B Vol 1/Ed 14 - 2014
H/B Vol 1/Ed 15 - 2015
H/B Vol 1/Ed 16 - 2016
H/B Vol 1/Ed 17 - 2017
H/B Vol 1/Ed 18 - 2018
H/B Vol 1/Ed 19 - 2019
H/B Vol 1/Ed 20 - 2020
New Edition Annually.
Locum Publishers Clients
(Handbooks and Journals
Handbook Generic Development
Oral Imediate Release Tablets
A Two Part Development To Final Production Handbook
Locum International Press
Volume 1 - (Complete
Handbook in Two Parts)
of the 24 Volume Drug Development Series.
This Handbook of Pharmaceutical Generic Development is a practical hands-on
workbook covering the essential drug development for single dose Oral
It promotes the development and sharing of practical drug development
knowledge and solid dose technology from government agency and industry
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 CTD/ANDA forms and modules
An Essential Reference for Development Pharmacists, R&D Chemists, QA/QC,
Production 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 CTD/NDA Development with a high-tech detailed integrated
development know-how for quick approval of product files.
Specific Additional modules: - Bupropion, Buspirone, Diclofenac, Famotidine,
Felodipine, Nabumetone, Naproxin, Piroxicam, Tamoxifen, Ticlopidine,
Trazodone plus other titles.
Volume in two parts 1790-1850 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 additional license) ISBN:
0793-8632 / 0793-8640
Locum International Press are one of the world leading
scientific R&D publishers offering an exceptional range of peer
reviewed journals, handbooks, book databases and publishing services
to the pharmaceutical science community. We also offer a large and comprehensive
range of product specific generic handbooks to the pharmaceutical generic
drug and innovative drug R&D community.
All air shipping is 100% insured for
loss or replacement. Shipping rates
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