Levothyroxine Sodium Tablets - In Vivo Pharmacokinetic and Bioavailability Studies and In Vitro Dissolution Testing

Description

This guidance is intended to assist sponsors of new drug applications (NDAs) for levothyroxine sodium tablets who wish to conduct in vivo pharmacokinetic and bioavailability studies and in vitro dissolution testing for their products. Information from these studies would generally be submitted in section 6 of an NDA. Sponsors who wish to use approaches other than those recommended in this guidance should discuss their plans with the FDA prior to preparing an NDA.

Scope & Applicability

Regulatory Context

• 21CFR320.22§ 320.22 Criteria for waiver of evidence of in vivo bioavailability or bioequivalence.

  (a) Any person submitting a full or abbreviated new drug application, or a supplemental application proposing any of the changes set forth in § 320.21(c) , may request FDA to waive the requirement for the submission of evidence measuring the in vivo bioavailability or demonstrating the in vivo bioeqRead full regulation →

• Guía para la Industria: Pruebas de disolución de formas de dosificación oral sólidas de liberación inmediata. (Status: Final)
• Dissolution Testing of Immediate Release Solid Oral Dosage Forms (Status: Final)
• Variations in Drug Products that May Be Included in a Single ANDA (Status: Final)