Question

how useful is microdosing in the drug development process. Under which circumstances should it be used and what information can it provide that a regular/traditional IND cannot provide? please include references

Answer 1

  Microdosing: a screening test for New Medical Entities (NMES): Microdosing will act as a screening test for drug candidates (NMEs) and allow only pharmacokinetically promising compounds to go further in clinical trial and thus will have significant role in reducing animal use. And thus, time, money and efforts that would have been wasted in further development of compounds with suboptimal PK can be utilized in constructive manner. The fundamental concept of Microdosing is that under conditions of pharmacokinetic dose proportionality, pharmaco- kinetic data obtained at lower doses can be used to predict PK at higher doses.

appplications of microdosing

Impact on animal use

Impact on financial aspect

Impact on Human Exposure:

Discovery of Endogenous Biomarker

Application in Oncology

For further details check the references given below

1 Hague J: Microdosing: A New Approach to Clinical Drug Development. Innovation in Clinical Trials 2004; 10-14.

2. Pradnya Shinde:

MICRODOSING: A NEW STRATEGY FOR DRUG DEVELOPMENT PROCESS.