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CDSCO BABE guidelines
34 pages
Published by
amit545
GUIDELINES FOR
BIOAVAILABILITY &
BIOEQUIVALENCE STUDIES
Central Drugs Standard Control Organization,
Directorate General of Health Services,
Ministry of Health & Family Welfare,
Government of India,
New Delhi.
(March 2005)
These...
[More]
GUIDELINES FOR
BIOAVAILABILITY &
BIOEQUIVALENCE STUDIES
Central Drugs Standard Control Organization,
Directorate General of Health Services,
Ministry of Health & Family Welfare,
Government of India,
New Delhi.
(March 2005)
These guidelines should be read in conjunction with Schedule Y to the Drugs and
Cosmetic Rules, GCP Guidelines issued by CDSCO, Ministry of Health and
Family Welfare, GLP and the Ethical Guidelines for Biomedical research on
human subjects issued by Indian Council of Medical Research.
All provisions
described in above documents shall appropriately apply to the conduct of
bioavailability and bioequivalence studies.
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Tags
bioavailability,
bioequivalence,
clinical,
control,
design,
documentation,
drug,
drugs,
guidelines,
modified,
products,
release,
standard,
studies,
study,
subjects,
vitro
Putman Media, Control Design, design and manufacture of machinery, industrial machine, Manufacturing, Equipment, Machinery, machine, industrial, manufacturer, Engineering,
Pub. on
Feb. 11th 2011
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