Handbook of Pharmaceutical Drug Development
Process Validation
A Four Part Development Handbook

Locum International Press

Volume 23 - (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, hands-on workbook covering the complete product development know-how of pharmaceutical validation from A to Z 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 12 major pharma dosage forms with checklists covering eradication of common validation error. Detailed coveragr of Tablets IR, CR, DR, MR; Capsules IR ER, SR and SGC; Oral Liquids; Oral Suspensions (liquid + reconstituted); Semisolids (creams/ointments/gels); Sterile Ophthalmic/Nasal Preparations, and Sterile Injections

This complete four part volume provides development reports, formulation optimization, scale-up, process qualification protocols (all dosage forms); pivotal protocol 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. A wide and comprehensive set all dosage form protocols with results and flowcharts

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, semisolid and sterile dosage form drug development from a generic and innovative industry viewpoint

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.

Essential development know-how on all aspects of Process Validation for professional developers to understand the complete nuts-and-bolts of both Innovative and 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. Table of Contents.

ISSN 0793 7601 / 0793-8802

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