|
Can Micro Dosing trials replaces Preclinical Evaluation in future; a review
|
|
| Author:
|
AYACHIT SHREYAS, KRISHNA K L, DESAI SNEHA, E SWERNA, SEEMA MEHDI
|
| Abstract:
|
Micro dosing (MD) trial is a novelty approach in the clinical trial sector where the study design is understood by dosing micro quantities of drug in patients participating clinical trial. The present review introduces the concept of MD in the context of phases of clinical trial including the position of MD trials in the hierarchy of clinical trials. We have highlighted the ethics involved in MD trials, regulatory guidelines for conducting MD trials, study design of MD trials including methodology of MD trial. Various advantages and disadvantages are explained for better understanding of MD trails. This review may also help the readers in understanding the various aspects of the analytical methods involved in analyzing the plasma samples at microdosing. The various analytical tools involved in the clinical study are AMS, PET and LC-MS/MS. Understanding the future prospective of MD trails will open many avenues in the field of clinical trials and we are tried to shed the light upon it. Many more review are required to elucidate the detailed approaches and standard protocols involved in the MD trails as well as their merits and demerits.
|
| Keyword:
|
Microdosing, Clinical trials, MD trials, AMS, PET
|
| EOI:
|
-
|
| DOI:
|
https://doi.org/10.31838/ijpr/2021.13.02.189
|
| Download:
|
Request For Article
|
|
|