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 technology.

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.

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 drug regulatory data associated with CMC and on Generic Drug development, manufacture, quality assurance and control.

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 departments.

80 - 95 pp illustrated b/w & color
Subscription Option Availability Print/CD/PDF or Online Drop Box

$1499.00 - Print Edition (single-user airmail print edition worldwide)
$1699.00 - Corporate single license single pharma campus - (Print / CD)
$1999.00 - Corporate multiple-user license - (print + CD edition maximizes distribution and readership for multiple pharma campus).

USA volume starts annually in March - Euro in June & Pacific Rim in September.

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