Main Content Widgets
Content Widget
Text
ICH has produced a comprehensive set of safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity. A recent breakthrough has been a non-clinical testing strategy for assessing the QT interval prolongation liability: the single most important cause of drug withdrawals in recent years.
Title
S1A - S1C Carcinogenicity Studies
Accordions
Title
S2 Genotoxicity Studies
Accordions
Title
S3A - S3B Toxicokinetics and Pharmacokinetics
Accordions
Title
S4 Toxicity Testing
Accordions
Title
S5 Reproductive Toxicology
Accordions
Title
S6 Biotechnological Products
Accordions
Title
S7A - S7B Pharmacology Studies
Accordions
Title
S8 Immunotoxicology Studies
Accordions
Title
S9 Nonclinical Evaluation for Anticancer Pharmaceuticals
Accordions
Title
S10 Photosafety Evaluation
Accordions
Title
S11 Nonclinical Paediatric Safety
Accordions
Title
S12 Non-clinical Biodistribution Considerations for Gene Therapy Products
Accordions
Title
S13 Nonclinical safety studies for Oligonucleotide-based Therapeutics
Accordions
Show page in full width
Off