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.

"No development unit should be without it -Pliva"

"packed with know-how and very useful protocols... -AstraZeneca.

Handbook Generic Development
Oral CR Tablets
A Two Part Development Handbook

Locum International Press


Volume 10 - (Complete Handbook in Two Parts)
of the International 24 Volume Drug Development Series

Handbook of Pharmaceutical Generic Development is a fully comprehensive practical hands-on workbook covering modern drug development and the full CTD/ANDA section interactions of a Extended or Modified Controlled Release Oral Tablet or Caplet. Table of Contents for both US and EU eCTD and CTD modules.

Handbook volume provides an outstanding authoritative and definative reference for critical documentation (including updated patent and exclusivity information) and OGD regulatory know-how that is essential for a successful first time review and agency approval, saving months of queue-time and market place sales.

Each and every regulatory guideline is covered in clear detail providing a development protocol for a totally omission-free file submission.

Designed to specifically eliminate the potential risks and common process omissions that occur during the drug development and validation process. Widely claimed as the world's most authoritative and definitive work available on specific dosage form drug development from a both a generic and innovative industry viewpoint.

An essential reference for development pharmacists, R&D Chemists, QA/QC and regulatory personnel.

Allows management to fully understand the nuts and bolts on Generic ANDA development and filing and how to get to the market place - quickly and on time.

Complete Volume in two parts 1890-2000 pp. Part 1 and 2 fully illustrated and annotated with diagrams, flow charts, formula, graphs, spectra, side-by-side comparisons, tables in b/w & color. Available in print (spiral soft cover opens flat) or via digital CD (multi-users require additinal optional license)

ISSN: 0793-8772 / 0793-8780

Price: Locum International Catalog

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