GUIDELINES TO ACTR ON NONCLINICAL DATA: THAILAND

GUIDELINES TO ACTR ON NONCLINICAL DATA:

PARAMETERS Guideline /

Reference

1.0 PHARMACOLOGY

M3 Nonclinical Safety Studies for the Conduct of Human

Clinical Trials for Pharmaceuticals

ICH-M3

62 FR 62922

Safety Pharmacology Studies for Human Pharmaceuticals ICH-S7A

2.0 PHARMACOKINETICS

Pharmacokinetics: Guidance for Repeated Dose Tissue

Distribution Studies

ICH-S3B

Toxicokinetics: Guidance on The Assessment of Systemic

Exposure in Toxicity Studies

ICH-S3A

3.0 TOXICOLOGY

3.1 /3.2

􀂃 Single and Repeat Dose Toxicity

Single Dose Acute Toxicity Testing for Pharmaceuticals ICH-S4

61 FR 43934

Nonclinical Safety Studies for the Conduct of Human Clinical

Trials for Pharmaceuticals

ICH-M3

62 FR 62922

Duration of Chronic Toxicity Testing in Animals (Rodent and

Nonrodent)

ICH-S4A

3.3 􀂃 Genotoxicity

Specific Aspects of Regulatory Genotoxicity Tests for

Pharmaceuticals

ICH-S2A

A Standard Battery for Genotoxicity Testing of

Pharmaceuticals

ICH-S2B

3.4 􀂃 Carcinogenicity

Guidelines on the Need for Carcinogenicity Studies of

Pharmaceuticals

ICH-S1A

Testing for Carcinogenicity of Pharmaceuticals ICH-S1B

Dose Selection for Carcinogenicity Studies of

Pharmaceuticals

ICH-S1C

Dose Selection for Carcinogenicity Studies of

Pharmaceuticals: Addition of a Limit Dose and Related Notes

ICH-S1C(R)

3.5 􀂃 Reproductive Toxicity

Detection of Toxicity to Reproduction for Medicinal Products ICH-S5A

Detection of Toxicity to Reproduction for Medicinal Products:

Addendum on Toxicity to Male Fertility Studies

ICH-S5B (M)

􀂃 Biotechnology Products

Safety Studies for Biotechnological Products ICH-S6