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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
- Pliva
- Lek dd
- Ivax
-Teva

"...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

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 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.

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 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

Readership

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 personnel.

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

About Us
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.


Price: Locum International Catalog

All air shipping is 100% insured for loss or replacement. Shipping rates are: | Standard | Priority | Expedited.|




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