Good Clinical Practice eRegs & Guides provides a
reference to key US FDA Guides and regulations via your electronic reader. An
excellent way to access the reference documents on your e-reader. No need to
carry paper books and you can search for key terms.

In this issue you will find:

ICH - Safety Guidelines S1A – S9

S1A Guideline on the Need for Carcinogenicity
Studies

S1B Testing for Carcinogenicity of
Pharmaceuticals

S1C(R2) Dose Selection for Carcinogenicity
Studies of Pharmaceuticals

S2(R1) Guidance on Genotoxicity Testing and Data
Interpretation for Pharmaceuticals Intended for Human Use

S3A Note for Guidance on Toxicokinetics: The
Assessment of Systemic Exposure in Toxicity Studies

Pharmacokinetics: Guidance for Repeated Dose
Tissue Distribution Studies

S4 Duration of Chronic Toxicity Testing in
Animals (Rodent and Non Rodent Toxicity Testing)

S5(R2) Detection of Toxicity to Reproduction for
Medicinal Products & Toxicity to Male Fertility

S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived
Pharmaceuticals

S7A Safety Pharmacology Studies For Human
Pharmaceuticals

S7B The Non-Clinical Evaluation of the Potential
for Delayed Ventricular Repolarization (QT Interval Prolongation) By Human
Pharmaceuticals

S8 Immunotoxicity Studies for Human
Pharmaceuticals

S9 Nonclinical Evaluation for Anticancer
Pharmaceuticals