Int. Journal of Generic Drug Registration
Covering Solid, Semisolid, Liquid
& Sterile Dosage
Locum International Press.
Each volume contains eight issues per year.
The International Journal of Generic Drug Registration
A specialist pharmaceutical journal covering all 22 ANDA Sections, 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. Sectors
(1- 22) including detailed aspects of ANDA (bio/pivotal) and commercial
validation batch manufacture.
Reviews in great detail (on a page-for-page) all 22 ANDA Sections 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 ANDA 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.
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.
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
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
80 - 95 pp illustrated
b/w & color
Subscription Option Availability Print/CD/PDF via e-mail/Online
$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).