ICH SAFETY GUIDELINES

0
752
WhatsApp D. Pharma Group Join Now
Telegram D. Pharma Group Join Now
Telegram Group Latest Pharma Jobs Join Now
Telegram B. Pharma Group Join Now
Telegram Medicine Update Group Join Now
WhatsApp B. Pharma/ GPAT Channel Join Now

In order to identify potential dangers including carcinogenicity, genotoxicity, and reprotoxicity, ICH has created a thorough set of safety guidelines. A non-clinical testing approach for determining the QT interval prolongation liability—the leading factor in drug withdrawals in recent years—has made significant strides recently.

S1A – S1C: Carcinogenicity Studies

S1A: Guideline on the need for carcinogenicity studies of pharmaceuticals

S1B: Testing for Carcinogenicity of Pharmaceuticals.

S1C (R2): Dose Selection for Carcinogenicity Studies of Pharmaceuticals.

S2: Genotoxicity Studies

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

S3A – S3B: Toxicokinetic and Pharmacokinetics

S3A: Note for guidance on toxicokinetics: The assessment of systemic exposure In toxicity studies

S3B: Pharmacokinetics: Guidance for repeated dose tissue distribution studies

S4: Toxicity Testing

S4: Duration of chronic toxicity testing in animals (rodent and non rodent Toxicity testing)

S5: Reproductive Toxicity

S5(R2): Detection of toxicity to reproduction for medicinal products & Toxicity to male fertility.

S5 (R4): Maintenance EWG Revision of S5 guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals.

S6: Biotechnological Products

S6(R1): Preclinical safety evaluation of biotechnology – Derived pharmaceuticals

S7A-S7B: Pharmacology Studies

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: Immunotoxicology Studies

S8: Immunotoxicity studies for human pharmaceuticals.

S9: Nonclinical Evaluation for Anticancer Pharmaceuticals.

S10: Photosafety Evaluation of Pharmaceuticals.

S11: Nonclinical Paediatric Safety

S11: Nonclinical safety testing in Support of Development of Paediatric Medicines.

S12: Nonclinical Biodistribution Considerations for Gene Therapy Products.

LEAVE A REPLY

Please enter your comment!
Please enter your name here