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.

"Very satisfactory - a truly excellent series"- LEK dd.

Handbook Generic Development
Oral IR Capsules
A Two Part Development Handbook

Locum International Press.

Volume 02 - (Complete Handbook in Two Parts)
of the 24 Volume Drug Development Series.

This definitive Handbook of Pharmaceutical Generic Development is an essential workbook and reference covering the full development, formulation, CMC, RA and legal sections for a single dose capsule ANDA development project.

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.

This Handbook of Pharmaceutical Generic Development is a practical hand-on workbook covering the practical hands-on development for single dose oral capsules. It promotes the development and sharing of practical drug development knowledge and solid dose technology from government agency and industry experts alike.

Complete development know-how and common error erdication with detailed commercial and state-of-the-art formula provides essential capsule technology know-how on all aspects of; Development, Formulation, Dissolution, stability, Scale-up, Process Optimization & Qualification; Pivotal and large scale Validation batches; Analytical, cleaning and process validation; essential documentation and OGD regulatory know-how that is essential for a successful review for a FDA approval, saving queue-time and money.

Essential development know-how on Oral Capsules for professional developers to understand the nuts-and-bolts on Generic ANDA drug development to produce flawless files

Complete Volume in two parts 1690-1850 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 additinal optional license)

ISBN: 0793-8731 / 0793-8722

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Price: Locum International Catalog

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