Available: Print or CD
Promotes the development and sharing of
practical drug development knowledge and technology by agency and industry
experts alike.
The world's most definitive & authoritative current generic drug
development series available.
"Very satisfactory - a truly excellent series"-
LEK dd.
"The most comprehensive reference
works in our reference library" - KRKA.
LOCUM INT. PRESS
Standard & Advanced Edition # and Pub. Year
H/B Vol 10 -2010
H/B Vol 11 -2011
H/B Vol 12 -2012
H/B Vol 13-2013
H/B Vol 14-2014
H/B Vol 15-2015
H/B Vol 16-2016
H/B Vol 17-2017
H/B Vol 18-2018
H/B Vol 19-2019
New Edition Annually
Print or electronic. Licenced or unlicenced.
Printable or read only e-editions.
Handbook Generic Development
Semisolids
Topical
A Two Part Development Handbook
Locum International Press
Volume 03
- (Complete Handbook in Two Parts)
of the International 24 Volume Drug Development Series
Handbook of Pharmaceutical Generic Development - Complete coverage from
pre-formulation of Generic CTD/ ANDA to final FDA filing - detailing more
than 150 key product development steps. Developmental Checklists clarify
the key Generic issues that the FDA routinely address during CTD/ANDA
file review and pre-approval inspection.
Checklists dovetail with Guidelines on a key Standard Operating Procedure
detailing real-life examples from A (actives) to V (validation). Packed
with hands-on Charts, Diagrams SOPs, Summaries, Tables and guidelines.
Describes over 150 drug development steps.
Each development stage is supplemented with unique Checklists and specific
key Development SOPs.
Who this book is for: This handbook of Pharmaceutical Generic Development
is an essential workbook for the full CTD/CMC and eCTD development and
all modules required for of a fault free generic development.
Product Development know-how provides development, formulation, diffusion
profiles, stability, full specifications, process optimization & qualification,
scale-up, pivotal batch, technical transfer documentation, analytical
cleaning and commercial batch-size process validation.
Inter-linked with legal and regulatory know-how that is essential for
a successful review for a FDA approval, saving queue-time and money.
Essential reading for Development Pharmacists, R&D Chemists, QA and regulatory
personnel. Allows management to understand the nuts and bolts on Generic
ANDA development and filing in the most cost effective way. A complete
training model for pharmaceutical graduates
Complete
Volume in two parts 1690-1850 pp. Part 1 and 2 fully illustrated with
diagrams, flow charts, graphs, side-by-side comparisons, tables in b/w
& color. Available in print (spiral soft cover open flat) or via digital
CD (multi-users require additinal optional license)
ISBN: 0793-8676
/ 0793-8689
Price: Locum
International Catalog
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