Study Set Content:
Q4-Q4B
PHARMACOPOEIAS
Q5A-Q5E
QUALITY OF BIOTECHNOLOGICAL PRODUCTS
Q6A-Q6B
SPECIFICATIONS
Q7
GOOD MANUFACTURING PRACTICE
Q8
PHARMACEUTICAL DEVELOPMENT
Q9
QUALITY RISK MANAGEMENT
Q10
PHARMACEUTICAL QUALITY SYSTEM
Q11
DEVELOPMENT AND MANUFACTURE OF DRUG SUBSTANCES
ICH has produced a comprehensive set
of safety Guidelines to uncover potential
risks like
carcinogenicity, genotoxicity
and reprotoxicity.
A recent breakthrough has been a
nonclinical testing strategy for assessing
the(blank) the single most important cause of drug
withdrawals in recent years.
QT interval prolongation liability
S1A-S1C
CARCINOGENICITY STUDIES
S2
GENOTOXICITY STUDIES
S3A-S3B
TOXICOKINETICS AND PHARMACOKINETICS
S4
TOXICITY TESTING
S5
REPRODUCTIVE TOXICOLOGY
S6
BIOTECHNOLOGICAL PRODUCTS
S7A-S7B
PHARMACOLOGY STUDIES
S8
IMMUNOTOXICOLOGY STUDIES
S9
NONCLINICAL EVALUATION FOR ANTICANCER PHARMACEUTICALS
S10
PHOTOSAFETY EVALUATION
