Toxicology Studies for Inhaled and Nasal Delivery.
This review examines issues related to the toxicological testing of pharmaceuticals delivered by the inhalation or nasal route. The purpose of the toxicology studies is to conduct studies in animals that will aid the assessment of the safety of these agents delivered to patients. Inhalation toxicology studies present some unique issues because the dosing method differs from more standard administration methods such as oral or injection administration. Also, dose determination issues are more complex, particularly for inhalation administration since it is often difficult to determine the amount of material delivered to the lung both for patients and in animal toxicology studies.
RK Wolff - Safety Consulting Inc, Fort Myers, Florida 33907, United States.
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Wolff
D000280:Administration, Inhalation; D000281:Administration, Intranasal / Q000009:adverse effects*; D000336:Aerosols / Q000009:adverse effects* / Q000633:toxicity*; D000818:Animals; D004305:Dose-Response Relationship, Drug; D006801:Humans; D019570:Inhalation Exposure / Q000009:adverse effects; D023421:Models, Animal; D059085:Nasal Sprays; D018675:Toxicity Tests
D000336:Aerosols; D059085:Nasal Sprays
MMAD; aerosols; excipients; inhalation toxicology; inhaled pharmaceutical; lung; nasal; pulmonary; respiratory tract toxicity