Preparation safety
The safety test of the preparation mainly includes irritation, anaphylaxis and hemolytic test, which refers to the local toxicity (such as irritation and local anaphylaxis, etc.) and/or systemic toxicity (such as systemic anaphylaxis and hemolytic, etc.) of the drug preparation administered through the skin, mucosa, cavity, blood vessels and other non-oral routes, and is an integral part of the preclinical safety evaluation.
Category: Non-clinical safety evaluation
Medicines for human purposes
Preparation safety
The safety test of the preparation mainly includes irritation, anaphylaxis and hemolytic test, which refers to the local toxicity (such as irritation and local anaphylaxis, etc.) and/or systemic toxicity (such as systemic anaphylaxis and hemolytic, etc.) of the drug preparation administered through the skin, mucosa, cavity, blood vessels and other non-oral routes, and is an integral part of the preclinical safety evaluation.
Irritation test
Vascular irritation test
Muscle irritation test
Skin irritation test
Mucosal irritation test: eye irritation test, nasal drops and inhalants irritation test, vaginal irritation test, rectal irritation test, oral drug irritation test, ear drops irritation test
Allergic test (guinea pig, rat, mouse) :
Active whole body allergy test
Passive skin allergy test
Active skin allergy test
Guinea pig Buehler Test (BT)
Guinea pig Maximization Test (GPMT)
Skin photoallergic reaction test
Hemolysis test: in vitro hemolysis test, in vivo hemolysis test
