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 anywhere.
"Your truly unique and excellent series - Ranbaxy"
"very comprehensive indeed" - Biochemie
Handbook Generic Development
SOPs
& e-SOPs
A Three Part Development Handbook
Locum International Press
Volume 06 (Complete
Handbook in Three Parts)
of the 24 Volume Drug Development Series.
Print + Electronic Standard Operating Procedures.
Available in Print or CD for immediate in-house use. Working examples
provided on how to convert development SOPs into your own customised
research-based-development system that meet all international regulatory
guides, guidelines and regulatory requirements.
350+ e-SOPs™ can be edited to meet your development units own in-house
needs. Designed for Generic and NDA use.
e-SOPs provide Development, Decision Trees,
Formulation, Scale-up, Process Optimization & Qualification; pivotal
and final large scale validation batches; analytical, cleaning and process
validation; essential documentation and generic regulatory know-how
that is essential for a successful product development and a speedy
FDA approval, saving queue-time and development dollars.
Essential information for Development Pharmacists, R&D Chemists, QA
and Regulatory personnel. Allows management to understand the nuts and
bolts on Generic CTD/ANDA and EC Development and filing in the most
cost effective way.
Complete
Volume in three parts 1790-1850 pp. Parts 1, 2 and 3 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 additinal optional license).
ISSN 0793
7641
All
air shipping is 100% insured for loss or replacement. Shipping rates
are:
| Standard | Priority | Expedited.|
Price:
Locum
International Catalog
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