Promotes the development and sharing of practical drug
development knowledge and sterile technology by agency and industry experts
alike.
The world's most definitive & authoritative current generic drug development
series available.
"the best handbook money can buy today - Berk" / KRKA.
Handbook Generic Development
SOPs
& e-SOPs
A Three Part Development Handbook
Locum Press Edition International..
Volume 06 (Complete
Handbook in Three Parts)
of the 24 Volume Drug Development Series.
Print + Electronic Standard Operating Procedures.
Available on CD or in print 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 two parts 1690-1850 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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| Ready-To-Go Link | Handbook Series | Journal Index | Specialized Journals |
