Description
Formas posológicas orales sólidas de liberación inmediata Cambios de escala y posteriores a la aprobación: documentación química, de fabricación y controles, de pruebas de disoluciónin vitroy bioequivalenciain vivo
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
1scope of the guidance document
Stakeholders
1Entity responsible for submitting the NDA
Regulatory Context
Regulatory Activities
3Recommendations for pharmaceutical sponsors of abbreviated antibiotic drug applications.
Abbreviated New Drug Application
New Drug Application
Document Types
2mecanismo de notificación para cambios de Nivel 2
mecanismo de notificación para cambios de Nivel 1
Attributes
1característica del fármaco que afecta el nivel de cambio
Technical Details
Substances
1componentes no activos de la formulación
Testing Methods
1Statistical method to compare dissolution profiles
Processes
2pruebas de liberación del fármaco
Scale-up manufacturing process change
Clinical Concepts
1estudios en sujetos humanos para comparar absorción
Standards & References
External Standards
1United States Pharmacopeia standards for compendial drug substances; confirming conformance to the application-approved specification and USP
Related CFR Sections (4)
- 21CFR310.3§ 310.3 Definitions and interpretations.
As used in this part:Read full regulation →
- 21CFR314.3§ 314.3 Definitions.
(a) The definitions and interpretations contained in section 201 of the Federal Food, Drug, and Cosmetic Act apply to those terms when used in this part and part 320 of this chapter .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 →
- 21CFR314.70§ 314.70 Supplements and other changes to an approved NDA.
(a) Changes to an approved NDA.Read full regulation →
Related MFDS Guidelines
Korean regulatory guidelines covering similar topics
See Also (8)
- 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)
- Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products (Status: Draft)
- 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)
- 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)
- Environmental Assessment of Human Drug and Biologics Applications: Guidance for Industry (Status: Final)
- Drug Master Files for Bulk Antibiotic Drug Substances: Guidance for Industry (Status: Final)
- Applications Covered by Section 505(b)(2) (Status: Draft)