Description
This guidance provides recommendations to pharmaceutical sponsors on methods to document in vivo bioequivalence of topical dermatologic corticosteroids, hereinafter referred to as topical corticosteroids.
Scope & Applicability
Product Classes
5Guidance for industry on in vivo bioequivalence for these products.; Subject of the bioequivalence guidance; Guidance title and subject of bioequivalence studies; Guidance title and subject of the bioequivalence study; The guidance pertains to bioequivalence establishment for these products.
The biological product to which a biosimilar is compared
Product being compared in the bioequivalence study
Development of a dose-response relationship for a topical corticosteroid; Actual times will depend upon the time of dosing and the topical corticosteroid being studied; Product applied to treated sites in the study
Class labeling for topical corticosteroids states that occlusive film may be used.
Stakeholders
9Target audience for the guidance
The study population required for the I/S potential evaluation.
Evaluable subjects who met the dose duration-response criterion
Entity required to file Form 1095-C
FDA personnel who view the application
Evaluable subject who meets dose duration-response criteria
Subject who shows the skin blanching response
Entity responsible for submitting applications under section 524B
only 'responders' should be included in the study
Regulatory Context
Attributes
10Method to control the dose of topical corticosteroid delivered; variable (DD) in the data tables ranging from 0.25 to 6 hours
Requirement for a proper confidence interval and meeting bioequivalence requirements
Criterion defined in Section V(H)(1)(c) for subject evaluability
Chromameter measurement used for skin color assessment
Dose duration selected as 4.0 hours for the pivotal study
Dose duration selected as 1.0 hour for the pivotal study
Maximum induction effect
Type of health coverage required to be offered
Dose corresponding to half the maximal vasoconstrictor response.; The dose duration to be used in the pivotal study
Area under the effect curve calculation for skin blanching.; Area under the effect curve used to measure pharmacodynamic responses; Area Under the Effect Curve calculated using the trapezoidal rule; Area Under the Effect Curve used as the response measure for baseline-adjusted and untreated control site-corrected data.
Related CFR Sections (1)
- 21CFR10.90§ 10.90 Food and Drug Administration regulations, recommendations, and agreements.
(a) Regulations. FDA regulations are issued in the Federal Register under § 10.40 or § 10.50 and codified in the Code of Federal Regulations. Regulations may contain provisions that will be enforced as legal requirements, or which are intended only as guidance documents and recommendations, or both.Read full regulation →
See Also (8)
- Metaproterenol Sulfate and Albuterol Metered Dose Inhalers In Vitro (Status: Final)
- CVM GFI #57 Preparation and Submission of Veterinary Master Files (Status: Final)
- SUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation (Status: Final)
- Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo Use (Status: Final)
- Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use: Guidance for Industry (Status: Final)
- Final In Vivo Bioavailability-Bioequivalence Studies- Analytical (Status: Final)
- Bioresearch Monitoring Technical Conformance Guide (Status: Final)
- Data Integrity for In Vivo Bioavailability and Bioequivalence Studies (Status: Draft)