Dissolution Testing of Immediate Release Solid Oral Dosage Forms

Description

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Dissolution Testing of Immediate Release Solid Oral Dosage Forms.'' The purpose of this guidance document is to provide general recommendations for dissolution testing, approaches for setting dissolution specifications related to biopharmaceutic characteristics of the drug substance, statistical methods for comparing dissolution profiles, and a process to help determine when dissolution testing is sufficient to grant a waiver for an in vivo bioequivalence study. This guidance document also provides recommendations for dissolution tests to help ensure continuous drug product quality and performance after certain postapproval manufacturing changes.

Scope & Applicability

Regulatory Context

• 21CFR314.94§ 314.94 Content and format of an ANDA.

  ANDAs are required to be submitted in the form and contain the information required under this section. Three copies of the ANDA are required, an archival copy, a review copy, and a field copy. FDA will maintain guidance documents on the format and content of ANDAs to assist applicants in their prepRead full regulation →

• 21CFR320.24§ 320.24 Types of evidence to measure bioavailability or establish bioequivalence.

  (a) Bioavailability may be measured or bioequivalence may be demonstrated by several in vivo and in vitro methods. FDA may require in vivo or in vitro testing, or both, to measure the bioavailability of a drug product or establish the bioequivalence of specific drug products. Information on bioequivRead full regulation →

• 21CFR314.50§ 314.50 Content and format of an NDA.

  NDAs and supplements to approved NDAs are required to be submitted in the form and contain the information, as appropriate for the particular submission, required under this section. Three copies of the NDA are required: An archival copy, a review copy, and a field copy. An NDA for a new chemical enRead full regulation →

• 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 →

• ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions (Status: Final)
• Guía para la Industria: Pruebas de disolución de formas de dosificación oral sólidas de liberación inmediata. (Status: Final)
• Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products: Guidance for Industry (Status: Final)
• Q5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products; Availability (Status: Final)
• Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (Status: Draft)
• Labeling OTC Human Drug Products Updating Labeling in RLDs and ANDAs (Status: Final)
• Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products: Draft Guidance for Industry (Status: Draft)
• Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAs (Status: Draft)