FDA 硫酸羟氯喹的产品特定指南：通用药物开发的产品特定指南.pdfVIP

Contains Nonbinding Recommendations Guidance on Hydroxychloroquine Sulfate This guidance represents the current thinking of the Food and Drug Administration (FDA, or the Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the Office of Generic Drugs. Active Ingredient: Hydroxychloroquine sulfate Dosage Form; Route: Tablet; oral Recommended Studies: Two options: Biopharmaceutics Classification System (BCS)- based biowaiver or in vivo study I. BCS Class 3-based biowaiver option: A waiver request of in vivo testing for this product may be considered provided that the appropriate documentation regarding high solubility, very rapid dissolution,1 and the test product formulation is qualitatively the same and quantitatively very similar as detailed in the Guidance for Industry: Waiver of In Vivo Bioavailability and Bioequivalence for Immediate- Release Solid Oral Dosage Forms Based on the Biopharmaceutics Classification System is submitted in the application. A decision regarding the acceptability of the waiver request will be made upon assessing the data submitted in the application. II. In vivo bioequivalence study option: 1. Type of study: Fasting Design: Single-dose, two- treatment, randomized, parallel in vivo Strength: 200 mg Subjects: Males and non-pregnant, non-lactating females, general population Additional comments: None _______________________________________________________________________ 2. Type of study: Fed Design: Singl