Available: Print or CD.
Promotes the development and sharing of practical
drug development knowledge and sterile technology by agency and industry
experts alike.
The world's most definitive & authoritative current generic drug development
series available anywhere.
Handbook Generic Development
Sterile
Injections
A
Two Part Development Handbook
Locum International Press
Volume 20 -
(Complete Handbook in Two Parts)
of the International 24 Volume Drug Development Series
This advanced Handbook of Pharmaceutical Generic Development (in two parts)
covers the key essential aspects of the development, formulation and manufacture
of sterile injections. It promotes the development and sharing of practical
drug development knowledge and sterile dose technology from government
agency and industry experts alike.
Covering pharmaceutical drug development by providing hands-on easy-to-understand
current know-how for the sterile product development, formulation, container
closure, scale-up, process optimisation and qualification, Sterile GMP,
aseptic procedures, stability, pivotal and comercial validation procedures
of sterile batch lots (Aqueous and lyophilized) with supporting SOPs,
protocols and checklists at every development and processing stage.
Includes IQ, OQ, PQ and equipment validation and comprehensive validation
checklists up to end-process validation, analytical, cleaning and process
validation, critical and essential documentation peppered with extensive
legal and regulatory know-how that is essential for a first time successful
review for a FDA approval, saving queue-time and lost market sales.
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)
ISSN 0793-8762 / 0793-8766
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for loss/damage.
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