Microdosing

Microdosing, or micro-dosing, involves the administration of sub-therapeutic doses of drugs to study their effects in humans, aiming to gather preliminary data on safety, pharmacokinetics, and potential therapeutic benefits without producing significant physiological effects. This is called a "Phase 0 study" and is usually conducted before clinical Phase I to predict whether a drug is viable for the next phase of testing. Human microdosing aims to reduce the resources spent on non-viable drugs and the amount of testing done on animals. [1]

Less commonly, the term "microdosing" is also sometimes used to refer to precise dispensing of small amounts of a drug substance (e.g., a powder API) for a drug product (e.g., a capsule)[2] and, when the drug substance also happens to be liquid, this can potentially overlap what is termed microdispensing. For example, psychedelic microdosing.[3]

  1. ^ Burt T, Young G, Lee W, Kusuhara H, Langer O, Rowland M, et al. (November 2020). "Phase 0/microdosing approaches: time for mainstream application in drug development?". Nature Reviews. Drug Discovery. 19 (11): 801–818. doi:10.1038/s41573-020-0080-x. PMID 32901140.
  2. ^ Tablets & Capsules, March 2009. "Micro-dosing equipment fills niche in R&D, clinical trial materials".
  3. ^ Gregoire C (13 January 2016). "Everything You Wanted to Know About Microdosing (But Were Afraid to Ask)". The Huffington Post.