Formulation Safety

The safety tests for pharmaceutical formulations primarily include irritation, sensitization, and hemolytic tests. These tests evaluate the toxicity—such as local irritation and local allergic reactions—that may occur at the site of administration when a drug formulation is administered via non-oral routes, including through the skin, mucous membranes, body cavities, and blood vessels, as well as any systemic toxicity—such as systemic allergic reactions and hemolysis—that may arise from systemic exposure. These tests are an integral part of preclinical safety evaluation.

Formulation Safety

Formulation Safety

The safety tests for pharmaceutical formulations primarily include irritation, sensitization, and Hemolysis tests. These tests evaluate the toxicity—such as local irritation and local allergic reactions—that may occur at the site of administration when a drug formulation is administered via non-oral routes, including through the skin, mucous membranes, body cavities, and blood vessels, as well as any systemic toxicity—such as systemic allergic reactions and hemolysis—that may arise from systemic exposure. These tests are an integral part of preclinical safety evaluation.

 

Irritation test

Vascular Irritation Test

Muscle Irritation Test

Skin Irritation Test

Mucosal Irritation Tests: Ocular Irritation Test, Irritation Test for Nasal Drops and Inhalants, Vaginal Irritation Test, Rectal Irritation Test, Oral Medication Irritation Test, Ear Drop Irritation Test

 

Allergy testing (guinea pigs, rats, mice):

Active Systemic Anaphylaxis Test

Passive Cutaneous Anaphylaxis Test

Active Cutaneous Anaphylaxis Test

Guinea Pig Buehler Test

Guinea Pig Maximization Test

Skin Photoallergenicity Test

 

Hemolysis test:

In Vitro Hemolysis Test

In Vivo Hemolysis Test (Animal Model)