1. The impact of FDA and EMEA guidelines on drug development in relation to Phase 0 trials
2. European Medicines Agency (EMA). Position paper on non‐clinical safety studies to support clinical trials with a single microdose.http://www.iaa-ams.co.jp/img_bsnss/MD1.pdfPublished 2004. Accessed May 10 2019.
3. US Food and Drug Administration (FDA). Guidance for industry investigators and reviewers: Exploratory IND studies.https://www.fda.gov/media/72325/downloadPublished 2006. Accessed May 10 2019.
4. European Medicines Agency (EMA). ICH M3 (R2): Note for guidance on non‐clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals.https://www.ema.europa.eu/en/documents/scientific-guideline/ich-m-3-r2-non-clinical-safety-studies-conduct-human-clinical-trials-marketing-authorization_en.pdfPublished 2009. Accessed May 10 2019.
5. Phase‐0/microdosing studies using PET, AMS, and LC‐MS/MS: a range of study methodologies and conduct considerations. Accelerating development of novel pharmaceuticals through safe testing in humans—a practical guide;Burt T;Expert Opin Drug Deliv,2016