Drug Metabolism in Drug Design and Development Basic Concepts and Practice

TABLE 7.1 Selected ICH and the US FDA guidances relevant to drug metabolism
and drug–drug interaction studies.

Regulatory guidance ICH FDA

Toxicokinetics S3A––Toxicokinetics:
the assessment of
systemic exposure in
toxicity studies, (ICH,
1995A)
Use of
radioactive
drugs

CFR Title 21, Part 361.1––
Radioactive drugs for certain
research Uses (FDA, 2005a)
Safety
assessment of
metabolites

S1C––Dose selection

for carcinogenicity

studies of

pharmaceuticals

(ICH, 1995b)

Carcinogenicity study
protocol submissions
(FDA, 2002)
Safety testing of drug metabolites
(FDA, 2005b)
Drug
interactions

Drug metabolism/drug
interaction studies in
the drug development
process: studiesin vitro(FDA, 1997)
In vivometabolism/drug
interaction studies––
study design, data analysis, and
recommendations
for dosing and labeling (FDA, 1999)
Drug interaction
studies––study design,
data analysis, and
implications for dosing
and labeling (FDA, 2006a)
Analytical
method

Q3B(R) - Impurities

in new drug substances

(ICH, 2006)

Bioanalytical method

validation (ICH, 1997b)

Q2(R1) - Validation of
analytical procedures:
text and methodology
(ICH, 2005)
Quality and
compliance

E6––Good clinical

practice: consolidated

guidance (ICH, 1997)

Good laboratory

practice for nonclinical

laboratory. CFR 21,

Part 58 (FDA, 2003d)

Part 11, Electronic

records; electronic

signaturesscope and

application (FDA, 2003c)

REGULATORY GUIDANCES RELEVANT TO DRUG METABOLISM 205