§ 320.1 Definitions

The definitions contained in § 314.3 of this chapter apply to those terms when used in this part.

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FDA guidance that cites § 320.1

• Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application 29 May 2026
• Statistical Approaches to Establishing Bioequivalence 29 May 2026
• CVM GFI #171 - Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Containing Active Pharmaceutical Ingredients Considered to Be Soluble in Aqueous Media 16 Jun 2023
• Regulatory Classification of Pharmaceutical Co-Crystals 15 Feb 2018
• Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations draft 18 Mar 2014
• Individual Product Bioequivalence Recommendations for Specific Products 10 Jun 2010
• ANDAs:Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls Information: Guidance for Industry 9 Jul 2007
• Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action draft 3 Apr 2003
• Applications Covered by Section 505(b)(2) draft 8 Dec 1999
• Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations 1 Sept 1997
• Guía para la Industria:  Formas de dosificación oral de liberación prolongada: elaboración, evaluación y aplicación de correlaciones in vitro/in vivo

Amendment history

Federal Register documents that created or amended this section.

• 42 FR 1648 7 Jan 1977
• 81 FR 69658 6 Oct 2016