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"
"what a pleasant surprise to our R&D
department -
Mallinckrodt.
Handbook Generic Development
Oral
Controlled Release 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 section interactions of a Extended or Modified Controlled Release
Oral Tablet or Caplet.
Advanced Development and process validation provide development,
master drug formulations, key processes, scale-up; process optimization
& qualification; stability; pivotal and final process validation Know-how
and protocols; PAI, analytical, cleaning and process validation with comprehensive
do's & don'ts check lists to eliminate common development faults.
An authoritative reference system for critical documentation and CTD know-how
that is essential for a successful first time FDA review and 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 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.
Allows management to 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
All air shipping
is 100% insured for loss or replacement. Shipping rates
are:
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| Priority | Expedited.|
Price:
Locum
International Catalog
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| Ready-To-Go Link | Handbook Series | Journal Index | Specialized Journals |
