Available as a electronic
publication on CD or printed
hard copy..

Handbook Generic Development
Master Formula & Processes

Locum International.

Volume 17 - (Ten Parts)
24 Volume Drug Development Series

This unique 10 part Series in the Handbook of Pharmaceutical Generic Development provides in each part, up to ten individual state-of-the-art real life commercial master formulations together with the full manufacturing process.

Title 17 allows researchers to view key formula and process data and then upgrade to the full database of the Title 21 CMC Ready-To-Go Production Dossiers.

All key processing and control details highlighted. Title 21 CMC are authoritatively written in a practical hands-on manner by pharma industry experts to the level of both FDA and MCA commercially approved manufacturing processes.

Formula and processes in the series are currently in actual production in the US or EU or both. Product and process specifications and quantities are exact commercial amounts.

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 appliations made simple and precise.

Total CD series is available as a complete ten part volume of 10 CDs with illustrated diagrams, graphs, tables in b/w/color. ISBN: 0793-6643

| Ready-To-Go Link | Handbook Series | Journal Index | Specialized Journals |