Handbook Generic Development
Oral DR Tablets
Two Part Development To Final Production Handbook
Locum International Press.
Volume 12 -
(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 state-of-the-art development for the full ANDA development
sections required for a Oral DR Tablet (Spay Granulation Enteric Coated
Delayed Release). Table of Contents for both US and EU eCTD and CTD modules.
Part Two (Technical Development) provide
practical key documentation and OGD regulatory know-how that is essential
for a successful review for a FDA approval, saving queue-time and money.
Designed to specifically eliminate the potential risks and process omissions
in drug development and claimed as the world's most authoritative and
definitive work available on oral dosage form drug development from a
generic industry viewpoint.
An Essential Reference for Development Pharmacists, R&D Chemists, QA/QC
and Regulatory personnel.
Master Formula and detailed step-by-step processes are current US and
EU commercial generic drug product leaders. Essential development and
submission know-how on Delayed Release Oral Tablets for professional generic
developers to understand the nuts-and-bolts on Generic ANDA development
with a high-tech detailed working commercial ANDA know-how for quick approval
of ANDA files.
Volume 800-850 pp for Part 1 and 2 fully
diagrams, graphs, tables in b/w & color
All air shipping is 100% insured for loss or replacement.
Shipping rates are | Standard
| Priority | Expedited.
Price go to: Locum
| Handbook Series | Journal
Index | Specialized Journals