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"-
- Lek dd
"...handbooks are simply state-of-the-art"
know-how - Nortons UK.
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 Immediate Release Tablets
A Two Part Development To Final Production Handbook
Volume 1 (Complete
Handbook in Two Parts)
of the 24 Volume Drug Development Series
This Handbook of Pharmaceutical Generic Development is a practical hand-on
workbook covering the essential drug development for single dose Oral
IR Tablets. It promotes the development and sharing of practical drug
development knowledge and solid dose technology from government agency
and industry experts alike.
Designed to specifically eliminate the potential risks and common process
omissions in drug development 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. 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 dossiers.
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 dovetailed in regulatory drug product applications
-worldwide applications made simple and precise.
Complete development know-how and common error eradication covers
pharmaceutical drug development and provides current know-how for the
development, formulation, dissolution, tips and traps, scale-up, process
qualification; stability, pivotal and final validation batches; analytical,
cleaning and process validation; critical documentation and OGD regulatory
know-how that is essential for a first time successful review for a
CTD approval, saving queue-time and market sales.
Essential development and submission know-how on Immediate Release Oral
Tablets for professional generic developers to understand the nuts-and-bolts
on generic ANDA development with a high-tech detailed integrated development
for quick approval of CTD/ANDA files
Development pharmacists, R&D chemists and scientists in pharmaceutical
companies and university departments, in the areas of innovative, new
drugs and generic drug development, QA / QC. validation and regulatory
Specific Additional modules:- Bupropion, Buspirone,
Diclofenac, Famotidine, Felodipine, Nabumetone, Naproxin, Piroxicam,
Tamoxifen, Ticlopidine, Trazodone plus other titles.
Complete Volumes standard and advanced
1850-1950 pp fully illustrated with diagrams, Flow charts, graphs, tables
in b/w & color. 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
are: | Standard
| Priority | Expedited.|
Link | Handbook Series | Journal
Index | Specialized Journals