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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 Drug Development
Process Validation
A Four Part Development Handbook

Locum International Press

Volume 14 - (Parts 1 to 4)
of the 24 Volume Drug Development Series.


This comprehensive four part Handbook of Pharmaceutical Generic Development volume is an updated, modern, practical, hand-on workbook covering the complete product development know-how of pharmaceutical validation and common error eradication from IQ/OQ/PQ through analytical, cleaning, optimization, scale-up, process qualification to end-product commercial process validation of full size marketing batch lots, covering the major pharma dosage forms.

This complete volume provide development, formulation, optimization, scale-up, process qualification; pivotal and final end-product validation batches; analytical, cleaning and commercial process validation; essential documentation, pivotal and commercial protocols, validation reports and drug development regulatory know-how that is essential for a successful review for a generic drug approval, saving both development dollars and lengthy queue-time

Designed to specifically eliminate the potential risks and common process omissions in drug development chain from start to finish of the development, analytical and manufacturing process. Claimed as the world's most authoritative and definitive work available on oral, liquid and sterile dosage form drug development from a generic industry viewpoint

Essential development know-how on all aspects of Process Validation for professional developers to understand the complete nuts-and-bolts of Generic CTD / ANDA / EU development including high-tech detailed working modules and systems for targeting fault-free approval of CTD/ANDA/EU modules and documents

Complete Volume ~1800 pp fully illustrated with diagrams, graphs, tables in b/w & color.

ISSN 0793 7601 / 0793-8802

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Price: Locum International Catalog






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