Biblioteca

All documents

VICH/IN/09/001 - Concept Paper on the proposed initiative to develop VICH guidance for studies that would establish an Acute Reference Dose for veterinary drug residues in food
Concept Papers

January 2009

Descargar VICH/IN/09/001 - VICH Revised Concept Paper on the proposed initiative to develop VICH guidance for studies that would establish an Acute Reference Dose for veterinary drug residues in food


VICH/IN/09/003 - Concept Paper on the Establishment of an Expert Working Group to Elaborate the Requirements to Demonstrate Bioequivalence
Concept Papers

January 2009

Descargar VICH/IN/09/003 - Concept Paper on the Establishment of an Expert Working Group to Elaborate the Requirements to Demonstrate Bioequivalence


VICH/IN/08/022-rev - Concept Paper requesting Revision of the GL 36
Concept Papers

December 2008

Descargar VICH/IN/08/022-rev - VICH Concept Paper requesting Revision of the GL 36


VICH/IN/08/020 - Concept Paper that proposes to revise GL33, General Approach to Animal Testing, to include References to the 3Rs Principle
Concept Papers

December 2008

Descargar VICH/IN/08/020 - VICH Concept Paper that proposes to revise GL33, General Approach to Animal Testing, to include References to the 3Rs Principle


VICH/IN/07009 - Proposal for a Concept Paper of VICH Bioequivalence Guideline for the Registration of Animal Products
Concept Papers

September 2007

Descargar VICH/IN/07009 - Proposal for a Concept Paper of VICH Bioequivalence Guideline for the Registration of Animal Products


VICH/13/063-dr2 - Draft 2 Concept Paper from the ESI EWG for the revision of VICH GL42
Concept Papers

July 2013

Descargar VICH/13/063


VICH/IN/07003 - IFAH-Europe Concept Paper on Electronic Presentation of Regulatory Documents
Concept Papers

July 2007

Descargar VICH/IN/07003 - IFAH-Europe Concept Paper on Electronic Presentation of Regulatory Documents


VICH/20/041-Final - Concept Paper for the adoption of ICH Q7: Good Manufacturing Practice for active pharmaceuticals ingredients
Concept Papers

November 2020

Descargar VICH/20/041-Final


VICH/17/025-Final - Concept Paper for a general guideline on pharmaceutical combination products
Concept Papers

March 2017

Descargar VICH/17/025-Final