Description
Oficina de Adiestramiento y ComunicacionesDivisión de la Gerencia de ComunicacionesThe Drug Information Branch, HFD-2105600 Fishers LaneRockville, MD 20857(Tel) 301-827-4573(Internet)Guidance (Drugs)
Scope & Applicability
Product Classes
1Guía para la industria sobre productos de liberación prolongada (ER)
Regulatory Context
Attributes
1Fármacos con menos de una diferencia doble entre concentraciones tóxicas y eficaces
Related CFR Sections (3)
- 21CFR320.33§ 320.33 Criteria and evidence to assess actual or potential bioequivalence problems.
The Commissioner of Food and Drugs shall consider the following factors, when supported by well-documented evidence, to identify specific pharmaceutical equivalents and pharmaceutical alternatives that are not or may not be bioequivalent drug products.Read full regulation →
- 21CFR320.1§ 320.1 Definitions.
The definitions contained in § 314.3 of this chapter apply to those terms when used in this part.Read full regulation →
- 21CFR210.3§ 210.3 Definitions.
(a) The definitions and interpretations contained in section 201 of the act shall be applicable to such terms when used in this part and in parts 211 , 225 , and 226 of this chapter .Read full regulation →
See Also (8)
- Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations (Status: Final)
- SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation: Guidance for Industry (Status: Final)
- ANDAs:Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls Information: Guidance for Industry (Status: Final)
- Individual Product Bioequivalence Recommendations for Specific Products (Status: Final)
- Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations (Status: Draft)
- 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)
- Formas posológicas orales sólidas de liberación inmediata Cambios de escala y posteriores a la aprobación: documentación química, de fabricación y controles, de pruebas de disolución in vitro y bioequivalencia in vivo. (Status: Final)
- SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation: Guidance for Industry (Status: Final)