Biblioteca

All documents

VICH/IN/13/015 - Concept Paper from FDA for the revision of VICH Anthelmintics GLs
Concept Papers

August 2013

Descargar VICH/IN/13/015 - Concept Paper from FDA for the revision of VICH Anthelmintics GLs


VICH/IN/10/014-Final - Concept Paper from IFAH-Europe for the revision of VICH GL3 (R)
Concept Papers

August 2013

Descargar VICH/IN/10/014 - draft 3 - Draft VICH Concept Paper from IFAH-Europe for the revision of VICH GL3 (R)


VICH/10/057-fin-rev - Concept Paper for the Establishment of an Electronic Standards Implementation of Adverse Event Reports Expert Working Group
Concept Papers

October 2010

Descargar VICH/10/057-fin-rev - VICH Concept Paper for the Establishment of an Electronic Standards Implementation of Adverse Event Reports Expert Working Group


VICH/IN/10/012 - VICH Bioequivalence: The VICH blood level BE Guideline: Summary of TF Perspectives
Concept Papers

June 2010

Descargar VICH/IN/10/012 - VICH Bioequivalence: The VICH blood level BE Guideline: Summary of TF Perspectives


VICH/10/050 - VICH Bioequivalence: Concept Paper on the establishment of an Expert Working Group to elaborate the requirements to demonstrate bioequivalence of veterinary pharmaceuticals by blood level studies
Concept Papers

July 2010

Descargar VICH/10/050 - VICH Bioequivalence: Concept Paper on the establishment of an Expert Working Group to elaborate the requirements to demonstrate bioequivalence of veterinary pharmaceuticals by blood level studies


VICH/IN/09/002-rev - Draft Concept Paper for the Harmonisation of the Target Animal Batch Safety Test for immunological veterinary medicinal products
Concept Papers

February 2009

Descargar VICH/IN/09/002-rev - Draft Concept Paper for the Harmonisation of the Target Animal Batch Safety Test for immunological veterinary medicinal products


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