S3B Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
March 1, 1995
April 24, 2020
05507ee5-4516-40d8-9c89-68fe4835e9fd
Related Documents
E1A The Extent of Population Exposure to Assess Clinical Safety: For Drugs Intended for Long-term Treatment of Non-Life-Threatening Conditions
Guidance DocumentMarch 1, 1995Center for Drug Evaluation and Research
M5International Conference on Harmonisation; Draft Guidance on M5 Data Elements and Standards for Drug Dictionaries
Guidance DocumentSeptember 6, 2005Center for Drug Evaluation and Research
E12A Principles for Clinical Evaluation of New Antihypertensive Drugs
Guidance DocumentAugust 9, 2000Center 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