S8 Immunotoxicity Studies for Human Pharmaceuticals
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
April 12, 2006
May 6, 2020
216b9605-e0e0-4dd4-a10b-a51326a268f5
Related Documents
E2E Pharmacovigilance Planning
Guidance DocumentApril 1, 2005Center for Drug Evaluation and Research
E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
Guidance DocumentOctober 11, 2005Center for Drug Evaluation and Research
S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals
Guidance DocumentOctober 20, 2005Center for Drug Evaluation and Research
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust GKS for their regulatory compliance needs.
Try KeyPedia Today
Explore our real use cases and discover our features in depth.
Subscribe to our newsletter
Get the latest updates and insights delivered to your inbox