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Available: Print or CD
Promotes the development and sharing of practical drug
development knowledge and technology by agency and industry experts alike.
The world's most definitive & authoritative current generic drug development
series available.
"No development unit should be without it -Pliva"
"packed with know-how and very useful protocols...
-AstraZeneca.
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Handbook Generic Development
Oral
CR Tablets
A Two Part Development
Handbook
Locum International Press
Volume 10 -
(Complete Handbook in Two Parts)
of the International 24 Volume Drug Development Series
Handbook of Pharmaceutical Generic Development is a fully comprehensive
practical hands-on workbook covering modern drug development and the full
CTD/ANDA section interactions of a Extended or Modified Controlled Release
Oral Tablet or Caplet. Table of Contents for both US and EU eCTD and CTD
modules.
Handbook volume provides an
outstanding authoritative and definative reference for critical documentation
(including updated patent and exclusivity information) and OGD regulatory
know-how that is essential for a successful first time review and agency
approval, saving months of queue-time and market place sales.
Each and every regulatory guideline is covered in clear detail providing
a development protocol for a totally omission-free file submission.
Designed to specifically eliminate the potential risks and common process
omissions that occur during the drug development and validation process.
Widely claimed as the world's most authoritative and definitive work available
on specific dosage form drug development from a both a generic and innovative
industry viewpoint.
An essential reference for development pharmacists, R&D Chemists, QA/QC
and regulatory personnel.
Allows management to fully understand the nuts and bolts on Generic ANDA
development and filing and how to get to the market place - quickly and
on time.
Complete
Volume in two parts 1890-2000 pp. Part 1 and 2 fully illustrated and annotated
with diagrams, flow charts, formula, graphs, spectra, 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)
ISSN:
0793-8772 / 0793-8780
Price:
Locum
International Catalog
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Link | Handbook Series | Journal
Index | Specialized Journals
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