Handbook Generic Development
Oral IR / CR / MR / DR / Chew Tablets
A Four Part Development Handbook
All Tablet dosage forms - COMBO PACK

Locum International Press.

Volume 14 (IR / Chew / CR / MR / DR)
24 Volume Drug Development Series

Availability Print & CD ROM

A new combined four part drug development volume from the word's most authoritative and acclaimed drug development publishers.Published at two levels
Volume 14 and Vol 16 which includes added development reports and expert reports

This major Handbook of Pharmaceutical Drug Development is a practical hand-on workbook covering all aspects of drug development in immediate, chew, modified and delayed release oral tablets. Designed for pharmaceutical and analytical development researchers who need to know all aspect of drug development including analytical, production, cleaning and key hands-on details of process and product validation.

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.

Pharmaceutical drug development modern cost effective technology providing current know-how for the initial development steps through formulation, dissolution, scale-up, process optimization and qualification; stability, pivotal (bio) and final end product validation batches; including analytical, cleaning and process validation. SOPs, checklists, Do's and Don'ts and flowcharts included.

Critical and essential documentation including legal and regulatory know-how that is essential for a first time successful review for a generic approval, saving months of development time and lost market sales.

Essential development and submission know-how covering immediate and extended/delayed release oral tablets for the professional drug developer to fully understand the nuts-and-bolts of all forms of tablet drug development with a high-tech integrated formulation charts, unique and advanced developmental procedures, active and excipient formulation charts, procedural flowcharts, decision trees, comparative tables, development and validation SOPs, protocols, checklists and much more.

Complete Volume +1800 pp for Part 1 to 4 fully illustrated with diagrams, graphs, tables in b/w & color as a complete volume of four parts.

ISSN: 0793-7763 / 0793-7764

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Price: Locum International Catalog

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

AVAILABILITY
a) Print
b ) Electronic CD - Read only (single user)
c ) Electronic CD - Print (Corporate user)
and may be
d ) Electronic CD - Licenced (Corporate user)
e ) Electronic CD - Unlicenced (Corporate user)