Comment from Anonymous
AnonymousSupportIndividual
Summary: The commenter suggests that the draft guidance should require more specific details regarding cell culture medium composition, serum batch numbers, and solvent control justifications. They also advocate for including studies from both male and female donors to ensure accurate results unless a drug is specifically for one sex.
The cell culture medium composition, including the batch number, and not the number. The serum, including any potential interference with the NAM, along with the batch and lot numbers, should also be provided.
The selection of solvent control should also be justified and included in all the experiments.
All studies should be performed on both male and female donors of the cells to obtain an accurate estimate of the results (of course, not in cases where a drug is only intended for the female or male population).