Handbook Generic Development
Sterile Eye Preparations
A Two Part Development Handbook

Locum International Press

Volume 08 - (Complete Handbook in Two Parts)
of the 24 Volume Drug Development Series

This Handbook volume provide development, pre and final formulation, scale-up process qualification; pivotal to final validation commercial batches; Analytical development, cleaning and process validation;

Essential documentation and US/EU deveopment regulatory know-how that is essential for a successful review for a product approval, saving queue-time and money.

Essential development know-how on EYE Preparations for professional innovative and generic drug developers to understand the practical nuts-and-bolts on Generic ANDA DEVELOPMENT with a high-tech detailed ANDA formulations and commercial processes.

This comprehensive Handbook of Pharmaceutical Generic Development is a practical hand-on authoritative work book covering the development to validation modules of CTD/ANDA sections for Sterile EYE Preparations namely ophthalmic drops, solutions and suspensions.

Promotes the development and sharing of practical drug development knowledge and sterile technology by agency and industry experts alike.

Complete Volume 1690-1850 pp for 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: 0793-8701 / 0793-8705

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Price: Locum International Catalog

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