Fingolimod hydrochloride 盐酸芬戈莫德.docVIP

精品资料 精品资料 PAGE / NUMPAGES 精品资料 Contains Nonbinding Recommendations Draft Guidance on Fingolimod Hydrochloride This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA, or the Agency) on this topic.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: Fingolimod hydrochloride Capsule; oral Dosage Form; Route: Recommended Studies: Two studies 1. Type of study: Fasting Design: Single-dose, two-treatment, two-period crossover in vivo Strength: EQ 0.5 mg Base Subjects: Males and non-pregnant, non-lactating females, general population Additional comments: 1. Ensure adequate washout periods between treatments in the crossover studies due to its long terminal elimination half-life. Consider using a parallel study design due to its long half-life. For long half-life drug products with low intra- subject variability in distribution and clearance, an AUC truncated to 72 hours may be used in place of AUC or AUC . For either a crossover or parallel study, sample 0-t 0-∞ collection time should be adequate to ensure completion of gastrointestinal transit of the drug product and absorption of the drug substance. Collect sufficient blood samples in the bioequivalence (BE) studies to adequately characterize the peak concentration (Cmax) and time to reach peak concentration (Tmax). 2. The study protocols and informed consent documents should include adequate information pertaining to the warnings and precautions as described in the approved drug label. 2. Type of study: Fed Design: Single-dose, two-treatment,