International Journal of Drug Development
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 CMCs area of NDAs and ANDAs. An excellent source
of know-how information on the nuts-and-bolts of drug development.
Keep informed of the important regulations FDA will adopt this year
so you can plan your drug development and manufacturing operations ahead
Learn what the FDA inspectors expect you to do to get new drug product
approved quickly. Keep on top of all trends related to the chemistry,
manufacturing and controls in the drug development and manufacturing
Stay current on PAI know-how, new regulations FDA is adopting this year
and important changes to GMP regulations affecting your drug development
and pivotal manufacture.
Model cleaning validation, process validation and analytical validation
protocols and plans that have passed successful PAI reviews.
The Journal will save your sales division tens of thousands on lost
sales by eradicating long CMC approval times with the Agency.
The Journal will speedup approval faster and reduce agency times by
eradicating universal NDA-CMC / ANDA pitfalls.
The Journal dissects and analyzes common and unusual drug development
and file submission faults and tell you how these hazards can be avoided
to achieve a speedier and less expensive approval.
to the Journal and we guarantee it will help you complete drug development
faster, cheaper and almost error free with the FDA’s regulators blessings.
The International Journal of Drug Development
Designed for pharmaceutical researchers in the NDA CMC (chemistry manufacture
control) and Generic Drug Development sectors including detailed aspects
of NDA/ANDA (bio/pivotal) and commercial validation batch manufacture.
Reviews key CMC processes and products.
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 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 and Generic Drug Development. The Journal emphasizes a multidisciplinary
approach between all key development and production departments.