Available: Print or CD.

Handbook Generic Development
Sterile Injections
A Two Part Development Handbook

Locum International Press.

Volume 20 - (Complete Handbook in Two Parts)
of the International 24 Volume Drug Development Series

This advanced drug debelopment Handbook of Pharmaceutical Generic Development (presented in two parts) covers the key essential aspects of the development, formulation and manufacture of sterile injections. It promotes the development and sharing of practical drug development knowledge and sterile dose technology from government agency and industry experts alike.

Covering pharmaceutical drug development by providing hands-on easy-to-understand current know-how for the sterile product development, formulation, container closure, scale-up, process optimisation and qualification, Sterile GMP, aseptic procedures, stability, pivotal and comercial validation procedures of sterile batch lots (Aqueous and lyophilized) with supporting SOPs, protocols and checklists at every development and processing stage.

Includes IQ, OQ, PQ and equipment validation and comprehensive validation checklists up to end-process validation, analytical, cleaning and process validation, critical and essential documentation peppered with extensive legal and regulatory know-how that is essential for a first time successful review for a FDA approval, saving queue-time and lost market sales.

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 0793-8754 / 0793-8744

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Price: Locum International Catalog

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