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