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                Guidances | Drugs

Guidances | Drugs

                        Product-Specific Guidances for Generic Drug Development
          Guidance Snapshot Pilot Home
          Drugs
          Guidance, Compliance, & Regulatory Information
          Guidances | Drugs
          Spanish Language GuidancesGuidances | Drugs Spanish Language Guidances
  
  	
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    Print**Disclaimer**:  These documents have undergone review by our Spanish speaking reviewers but not editing. The English version of the document is considered the official guidance on the topic.  All CDER guidances can be found at Guidances (Drugs).**Bioavailability/Bioequivalence**Guía para la Industria:  Pruebas de disolución de formas de dosificación oral sólidas de liberación inmediata.  English version: Dissolution Testing of Immediate ReleaseGuía para la Industria:  Formas de dosificación oral de liberación prolongada: elaboración, evaluación y aplicación de correlaciones in vitro/in vivo. English version: Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations. (Issued 9/97)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.    (Issued 11/1995, Posted 8/24/2001).  English version:  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.SUPAC-MR: Formas posológicas orales sólidas de liberación modificada Cambios en escala y posteriores a la aprobación: química, fabricación y controles; pruebas de disolución in vitro y documentación de bioequivalencia in vivo.   (Issued 9/1997, Posted 8/24/2001).  English version:  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.**Electronic Submissions**Presentaciones Regulatorias en Formato Electrónico - Registro de Establecimientos Farmacéuticos y Listado de Fármacos (May 2009).  English version: Providing Regulatory Submissions in Electronic Format - Drug Establishment Registration and Drug Listing**Good Manufacturing Practice**Normas de Buenas Practica Clinicas (BPC)   English version:   E6 Good Clinical Practice:  Consolidated Guideline.   (Issued 4/96)

                                                                                  Content current as of:
      03/12/2018Guidances | Drugs

          
                        Product-Specific Guidances for Generic Drug Development
          Guidance Snapshot Pilot
 
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