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Int. Journal of Process
Validation
Covering Solid, Semisolid &
Liquid Dosage Forms
Locum International
Press.
Each volume
contains eight issues per year.
The International Journal of Process Validation
A specialist pharmaceutical journal covering aspects on pharmaceutical
process validation, protocols and interpretation of validation test results.
Designed for pharmaceutical validation units in the NDA/ANDA CMC (chemistry
manufacture control) and drug development sectors including detailed aspects
of NDA/ANDA (bio/pivotal) and commercial validation batch manufacture.
Reviews key IQOQ, HVAC, Water, Analytical, Cleaning and Process Validation
and drug product specifications and range limits, through standardized
optimization and qualifications studies.
A forward looking peer reviewed journal that is relevant from the bench
to the boardroom. Addresses the most up-to-date developments in CMC technology.
An essential first read for drug development chemists and scientists
working in CMC arena of NDAs and ANDAs. An excellent source of know-how
information on the nuts-and-bolts of today's drug development pipeline.
Regulatory know-how
Key know-how on CDER and OGDs expectations of the bio/pivotal batch manufacture
highlighting side-by-side batch comparisons between bio/pivotal regulatory
batch lots and commercial validation batches.
Full coverage
A comprehensive new forum filled with essential process validation data
associated with CMC and Generic Drug Development, manufacture, analytical
and cleaning procedures.
Each issue targets a specific dosage form detailing developmental and
scale-up topics. Each Journal issue contains material dedicated to the
review of a specific dosage form and specific development and scale-up
topics.
This Journal features process validation articles, written technical protocols
and Validation Checklists, SOPs and Side-by-Side specification comparisons
of all major dosage form parameters ranging from A (Analytical)
to V (FP Validation).
A primary source journal to fill the ever changing information gap for
CMC and Generic Drug Validation. The Journal highlights a multidisciplinary
approach between all key development, engineering and production departments.
Subscription Option Availability Print
$1499.00 - Print Edition (single-user airmail print edition worldwide)
$1699.00 - Corporate single license single pharma campus - (Print)
$1999.00 - Corporate multiple-user license - (print + CD edition maximizes
distribution and readership for multiple pharma campus).
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