Int. Journal of Generic Registration
Locum International Press.
Issues Numbers 1 - 8
Each volume contains eight issues per year.
The International Journal of Generic Drug Registration
A specialist pharmaceutical journal covering aspects on Generic Drug Registration.
Designed for pharmaceutical researchers in the ANDA CMC (chemistry manufacture
control) and drug development sectors including detailed legal aspects
of ANDA (bio/pivotal) and end-product commercial validation batch manufacture.
Reviews key CMC processes and drug product parameters needed for filing.
A forward looking peer reviewed journal that is relevant from the bench
to the boardroom. Addresses the most up-to-date developments in CMC regulatory
An essential first read for drug development chemists and regulatory
scientists working in the CMC arena of ANDAs. An excellent source of know-how
information on the nuts-and-bolts of today's drug development regulatory
and legal requirements.
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.
A comprehensive new forum filled with essential drug regulatory data associated
with CMC and on Generic Drug development, manufacture, quality assurance
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 agency requirements from
development, scale-up and validation topics.
This Journal features drug development articles, technical reviews, procedural
checklists, SOPs and Side-by-Side specification comparisons of all major
dosage form parameters ranging from A (actives) to V (validation).
A primary source journal to fill the ever changing information gap for
CMC and Generic Drug Registration. The Journal highlights a multidisciplinary
regulatory approach between the various key development and production
80 - 95 pp illustrated
b/w & color
Subscription - Print
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