Handbook Generic Development
Oral IR &
Chew Tablets
A
Two Part Development Handbook
Locum International Press.
Volume 21 (Development
Volume in Two Parts)
24 Volume Drug Development Series
This Handbook of Pharmaceutical Generic Development is a practical
hand-on workbook covering the essential aspects on the drug development
for single dose Oral Tablets. It promotes the development and sharing
of practical drug development knowledge and solid dose technology from
government agency and industry experts alike. Table of Contents for
both US and EU eCTD and CTD modules.
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 ANDA forms and Guidelines on
CD
Essential development and submission know-how on immediate release
Oral Tablets for professional developers to understand the nuts-and-bolts
on Generic ANDA Development with a high-tech detailed integrated development
ANDA know-how for quick approval of ANDA files.
Specific Additional Titles Available: - Bupropion, Buspirone, Diclofenac,
Famotidine, Felodipine, Nabumetone, Naproxin, Piroxicam, Tamoxifen,
Ticlopidine, Trazodone plus other titles.
Complete Volume ~1800 pp fully
illustrated with diagrams,
graphs, tables in b/w & color.
Available on the web and
in print (soft or spiral cover)
or via CD ROM.
ISBN: 0793-8632
/ 0793-8640
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