Bioequivalence and Bioavailability Forum

Dear Cmaxsant!

❝ Common sense: […] appropriate precaution to avoid degradation while dosing…

Dosing? Have you read the linked posts (f.i. #752 and #2883)? Unless you are admin­is­tering a drug as a slow infusion from a transparent bottle this should not be an issue.

❝ …/sampling & analysis.

Sampling: What would you guess is the entry-depth of light into whole blood?
Problems (may) start once you separated plasma/serum and during analysis. But this has to be validated anyway.

❝ My concern is that many drugs are light sensitive, but they may have less sensitive (may negligible) - that can be justify by performing stability study analytically, even then do we need to perform the study in Light sensitive environment ??

If you have validated your method from sampling to the final analysis, act accordingly. Sometimes no light protection is sufficient and sometimes only at specific steps (e.g., handling stock solu­tions and extracts). In my experience light protection in the clinical phase is like cracking a nut with a sledgehammer.