FDA - Guidance on Tacrolimus

Contains Nonbinding Recommendations
Guidance on Tacrolimus

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic.
It does not create or confer any rights for or on any person and does not operate to bind FDA or the
public. You can use an alternative approach if the approach satisfies the requirements of the
applicable statutes and regulations. If you want to discuss an alternative approach, contact the Office
of Generic Drugs.
Active ingredient: Tacrolimus
Form/Route: Capsule/Oral
Recommended studies: 2 studies
1.
Type of study: Fasting Design: Single-dose, two-treatment, two-period crossover in-vivo
Strength: 5 mg
Subjects: Healthy males and nonpregnant females, general population.
Additional Comments:
_______________
2.
Type of study: Fed Design: Single-dose, two-treatment, two-period crossover in-vivo
Strength: 5 mg
Subjects: Healthy males and nonpregnant females, general population.
Additional comments:
_______________
Analytes to measure (in appropriate biological fluid): Tacrolimus in whole blood.
Bioequivalence based on (90% CI): Tacrolimus
Waiver request of in-vivo testing: 0.5 mg and 1 mg, based on (i) acceptable bioequivalence studies on the 5 mg strength, (ii) proportional similarity of the formulations across all strengths, and (iii) acceptable in vitro dissolution testing of all strengths.
Dissolution test method and sampling times:
Please note that a Dissolution Methods Database is available to the public at the OGD website at http://www.accessdata.fda.gov/scripts/cder/dissolution/. Please find the dissolution information for this product at this website. Please conduct comparative dissolution testing on 12 dosage units each of all strengths of the test and reference products. Specifications will be determined upon review of the application.
Finalized Sep 2009

abrir aquí:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM181006.pdf