Nitric Oxide Model for Inhaled Corticosteroid Dose呼出气一氧化氮吸入糖皮质激素剂量模型课件.pptVIP

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Nitric Oxide Model for Inhaled Corticosteroid Dose呼出气一氧化氮吸入糖皮质激素剂量模型课件.ppt

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Nitric Oxide Model for Inhaled Corticosteroid Dose呼出气一氧化氮吸入糖皮质激素剂量模型课件

Exhaled Nitric Oxide Model for Inhaled Corticosteroid Dose-response Badrul A. Chowdhury, MD, PhD Director Division of Pulmonary and Allergy Products US Food and Drug Administration, Rockville, MD Outline of the Presentation Comments on asthma and relevant regulatory framework Challenges in developing generic inhaled corticosteroids Exhaled nitric oxide to determine bioequivalence of inhaled corticosteroids Study using exhaled nitric oxide to show inhaled corticosteroid dose-response Asthma Chronic inflammatory disease of the airway Infiltration of mast cells, eosinophils, and lymphocytes Recurrent episodes of wheezing, coughing, and shortness of breath Airway hyperresponsiveness Widespread, variable, and reversible airflow obstruction Increased exhaled nitric oxide Drug Development NDA process: Sec. 505 (d) of FDC Act Adequate manufacturing and controls to ensure identity, strength, quality, and purity (QUALITY) Safety under conditions of labeled use (SAFETY) Substantial evidence of efficacy under conditions of labeled use (EFFICACY) ANDA process: Sec. 505 (j) of FDC Act Same active ingredients as listed drug Same strength, route, and dosage form as listed drug Bioequivalence to listed drug Same labeling as listed drug Exceptions for exclusivity claims Generic Drug Development Demonstration of bioequivalence (BE) to the reference listed drug is critical to the approval of a generic drug BE means “the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives become available at the site of drug action when administered at the same molar dose under similar conditions” [21 CFR 320.1(e)] Challenges in Demonstrating BE for Inhaled Corticosteroids (ICS) For drugs that reach their site of action through the systemic circulation, BE is demonstrated by drug concentration in a relevant biologic fluid, such as blood For orally inhaled drugs intended for