Business · 10/05/2018

FDA Releases Guidance on Toxicokinetics and Microsampling Techniques

The FDA has released a guidance document titled "S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies: Focus on Microsampling--Questions and Answers" prepared by the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. This Q&A guidance aims to clarify the use of microsampling techniques in toxicokinetic studies.