Handbook Generic Development
Oral IR Capsules
A Two Part Development Handbook

Locum International Press

Volume 02 - (Complete Handbook in Two Parts)
of the International 24 Volume Drug Development Series

This definitive annually updated Handbook of Pharmaceutical Generic Development is an essential workbook and reference workbook covering the RA sections for a single dose capsule ANDA development project. It promotes the development and sharing of practical drug development knowledge and solid dose technology from government agency and industry experts alike. TOC for US and EU eCTD and CTD.

Each product specific handbook focuses exclusively on single dosage form and in essence informs and guides the product developer (a) what exactly must be done (b) once it is completed how to write and format the raw data (c) what the agency expects to see in each section and (d) what the developer must not leave out.

Each and every agency guideline and development requirement is thoroughly dealt with in a step-by-step manner in order to avoid the common and unusual pitfalls occurring during routine product development, scale-up and final end-roduct validation including all aspects of analytical and production development.

Provides extensive Drug Development know-how in the CTD/ANDA development with detailed commercial and state-of-the-art formula and comprehensive process instructions. Complete legal format and key example forms and explanations on patents and exclusivity sectors.

Key documentation and OGD regulatory know-how that is essential for a successful review for a FDA approval, saving queue-time and money. Essential development know-how on Oral Capsules for professional developers to understand the nuts-and-bolts on Generic CTD/ANDA Development to produce flawless files for submission.

Complete Volume in two parts 1690-1850 pp. 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 opens flat) or via digital CD (multi-users require additinal optional license)

ISBN: 0793-8655 / 0793-8653

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Price: Locum International Catalog

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