Medical devices or pharmaceutical combination products used in combination with drugs, the adsorption of drugs during clinical use will directly affect the therapeutic effect of drugs, that is, effectiveness, especially for drugs administered at low doses, thereby posing a potential risk to patients.

In addition to leachable vs leachable studies, such medical devices should be evaluated scientifically and specifcally for compatibility studies of drugs and devices, including: pharmacocompatibility studies, drug adsorption studies, in vitro release studies, etc.

(1) Drug compatibility study: extractability, leachables of the material and the assessment of risks due to their interactions to the quality and functionality of the drug product to be used.

(2) Drug adsorption study: the change of drug concentration to characterize the adsorption rate as well as to carry out the study of drug quality change for the drug solution.

(3) In vitro release study of drugs: Test of in vitro release rate and release amount of drugs performed by medical device for drug combination.