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
Vol, Edition # and Pub. Year.

H/B Vol 21/Ed 16 - 2016
H/B Vol 21/Ed 17 - 2017
H/B Vol 21/Ed 18 - 2018
H/B Vol 21/Ed 19 - 2019
H/B Vol 21/Ed 20 - 2020
H/B Vol 21/Ed 21 - 2021
H/B Vol 21/Ed 22 - 2022
H/B Vol 21/Ed 23 - 2023
H/B Vol 21/Ed 24 - 2024

New Edition Annually

Locum Publishers Clients
(Handbooks and Journals

Handbook Generic Development
Oral IR & Chew Tablets

A Two Part Development To Final Production 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 applications 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 in print (soft or spiral cover)

ISBN: 0793-8632 / 0793-8640
All aircourier shipping is 100% insured for loss/damage. Shipping rates are: | Standard | Priority | Expedited.|

Price: Locum International Catalog




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