Handbook Generic Development
Oral Imediate Release Tablets
A Two Part Development Handbook

Locum International Press

Volume 01 - (Complete Handbook in Two Parts)
of the 24 Volume Drug Development Series.

This Handbook of Pharmaceutical Generic Development is a practical hands-on workbook covering the essential drug development for single dose Oral IR Tablets.
It promotes the development and sharing of practical drug development knowledge and solid dose technology from government agency and industry experts alike.

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 pitfalls occurring during product development. Includes all CTD/ANDA forms and modules and guidelines

Essential development and submission know-how on immediate release Oral Tablets for professional developers to understand the nuts-and-bolts on Generic CTD/NDA Development with a high-tech detailed integrated development know-how for quick approval of product files.

Specific Additional modules: - Bupropion, Buspirone, Diclofenac, Famotidine, Felodipine, Nabumetone, Naproxin, Piroxicam, Tamoxifen, Ticlopidine, Trazodone plus other titles.

Complete Volume in two parts 1790-1850 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) or via digital CD (multi-users require additional license)

ISBN: 0793-8632 / 0793-8640

Price: Locum International Catalog

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