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.
"This softgel handbook is truly a unique and excellent authoritative
reference source - Ranbaxy"
"simply the best reference we've got" - RP Scherer
Handbook Generic Development
Soft
Gelatin Capsules
A Two Part Development Handbook
Locum International Press
Volume 05 -
(Complete Handbook in Two Parts)
of the International 24 Volume Drug Development Series
SGC Handbook
provides essential SG capsule technology know-how on all aspects of development,
pre-formulation, final formulation, scale-up, process optimization &
process qualification; pivotal and large scale validation batches; analytical,
cleaning and process validation; essential documentation, protocols, checklists,
flowcharts and key SOPS designed in compliance with international regulatory
know-how that is essential for a successful review for a EU / FDA / ICH
/ Asian product development and approval, saving valuable queue-time and
costly development dollars.
The Handbook of Pharmaceutical Generic Development is an essential A to
Z SGC workbook covering modern technological advances, do's and don'ts,
lastest SGC development technology, complete analytical methology, production
CMC / CTD modules and sections for a single dose Soft Gelatin Capsule
CTD / ANDA development project up to and including full size large-scale
commercial production batchlots.
Critical and key development know-how on Oral Soft Gelatin Capsule for
advanced developers to understanding international compliance management
and the nuts-and-bolts on Generic SGC Development and manufacture maximizing
your detailed and comprehensive high-tech FDA-EU-ICH working knowledge
of Soft Gelatin Capsule know-how and particle engineering technologies
for better drug performance (including nanodosage forms)
Complete
Volume in two parts 1890-2000 pp. Part 1 and 2 fully illustrated and annotated
with diagrams, flow charts, formula, graphs, spectra, side-by-side comparisons,
tables in b/w & color. Available in print (spiral soft cover opens
flat) or via digital CD (multi-users require additinal optional license)
ISBN: 0793-8675
/ 0793-8683
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International Catalog
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