Pertinence of microsampling in various nonclinical and clinical studies: the ICH perspective
Londhe V & Rajadhyaksha M | Bioanalysis, 14(17), 1137-1139, (2022)
Keywords: • 3R • dried blood spot • dried matrix methods • ICH • microsampling • toxicokinetic
For a potential new drug candidate, it is mandatory to pass through a series of assessments related to safety, efficacy and quality before it is administered in humans.
The ICH is continuously bringing together regulatory authorities and the pharmaceutical industry to confer on various scientific and technical aspects of drug registration. The aim of harmonization is achieved through different guidelines which fall under four different categories: quality, safety, efficacy and multidisciplinary. The ICH takes into consideration the recommendations shared by regulators and industry experts. These guidelines are constantly reviewed and revised to include current scientific advances and social attention.
