Available: Print or CDD
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.
Handbook Drug Development
Process Validation
A Four Part Development
Handbook
Locum International Press
Volume
14 - (Parts
1 to 4)
of the 24 Volume Drug Development Series.
This comprehensive four part Handbook of Pharmaceutical Generic Development
volume is an updated, modern, practical, hand-on workbook covering the
complete product development know-how of pharmaceutical validation and
common error eradication from IQ/OQ/PQ through analytical, cleaning, optimization,
scale-up, process qualification to end-product commercial process validation
of full size marketing batch lots, covering the major pharma dosage forms.
This complete volume provide development,
formulation, optimization, scale-up, process qualification; pivotal and
final end-product validation batches; analytical, cleaning and commercial
process validation; essential documentation, pivotal and commercial protocols,
validation reports and drug development regulatory know-how that is essential
for a successful review for a generic drug approval, saving both development
dollars and lengthy queue-time
Designed to specifically eliminate the potential risks and common process
omissions in drug development chain from start to finish of the development,
analytical and manufacturing process. Claimed as the world's most authoritative
and definitive work available on oral, liquid and sterile dosage form
drug development from a generic industry viewpoint
Essential development know-how on all aspects of
Process Validation for professional developers to understand the
complete nuts-and-bolts of Generic CTD / ANDA / EU development including
high-tech detailed working modules and systems for targeting fault-free
approval of CTD/ANDA/EU modules and documents
Complete Volume ~1800 pp
fully illustrated
with diagrams, graphs, tables in b/w & color.
ISSN 0793
7601 / 0793-8802
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