KKBiotech Forum :
Biotechnologist Paving the Path for the young.
It is mandatory to test the drug metabolism and toxicity on in-vitro Hepatocytes models from various populations majorly Asian and Caucasian donors. The advantage is not only using non-animal models for testing but directly doing the test in-vitro using human live hepatocytes and kidney epithelial cells which have been cryopreserved and Skin tissues obtained from human donors.
It is mandatory to provide data of Drug-Drug interactions and Transporters studies using the in vitro models such as on Hepatocytes and Kidney epithelial cell lines. Skin based formulation must be tested by skin penetration studies as recommended by OECD guidelines of 428 (https://www.oecd-ilibrary.org/environment/test-no-428-skin-absorption-in-vitro-method_9789264071087-en).