Available: Print

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.

Note: Strongly recommended for innovative drug development, highlighting all common tips and traps of experienced drug developers.

"Thanks - a superb book "-

The drug development series made us rethink our development techniques - Lek dd.

"No development unit should be without it -Pliva"

Vol, Edition # and Pub. Year.

H/B Vol 2/Ed 19 - 2019
H/B Vol 2/Ed 20 - 2020
H/B Vol 2/Ed 21 - 2021
H/B Vol 2/Ed 22 - 2022
H/B Vol 2/Ed 23 - 2023
H/B Vol 2/Ed 24 - 2024
H/B Vol 2/Ed 25 - 2025

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 IR Tablets.
It promotes the development and sharing of practical drug development knowledge and solid dose technology from government agency and industry experts alike.

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 and guidelines

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.

Complete 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

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

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