Int. Journal of Drug Registration
Covering Solid, Semisolid, Liquid & Sterile Dosage
Dosage Forms.

Locum International Press.
Each volume contains eight issues per year.

The International Journal of Generic Drug Registration
A specialist pharmaceutical journal covering essential documents, layout & critucal aspects of Generic Drug Registration.

Designed for both regulatory affairs and pharmaceutical research manger in ANDA CMC (chemistry manufacture control) and drug development. Including detailed aspects of ANDA (bio/pivotal) and commercial validation batch manufacture.
Reviews in great detail (on a page-for-page) and key CMC documents and drug product parameters. Highlights precisely what the OGD expect to see in an ANDA.

A forward looking peer reviewed journal that is relevant from the bench to the boardroom. Addresses the most up-to-date developments on key legal issues (sections 1 to 5) in the FDA application. Expert reviews and tips from past and present OGD review chemists.

An essential first read for RA and drug development chemists and scientists working in CMC arena of NDAs. An excellent source of know-how information on the nuts-and-bolts of today's drug development regulatory guidences.

Regulatory know-how
Key know-how on CDER 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 development 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 development and scale-up 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 development and Generic Drug Registration. The Journal highlights a multidisciplinary approach between all key development 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 / CD)
$1999.00 - Corporate multiple-user license - (print + CD edition maximizes distribution and readership for multiple pharma campus).

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