International Conference on harmonisation of technical requirements for registration of pharmaceutic

International Conference on harmonisation of technical requirements for registration of pharmaceutic

Info iconThis preview shows pages 1–4. Sign up to view the full content.

View Full Document Right Arrow Icon

Info iconThis preview has intentionally blurred sections. Sign up to view the full version.

View Full DocumentRight Arrow Icon

Info iconThis preview has intentionally blurred sections. Sign up to view the full version.

View Full DocumentRight Arrow Icon
This is the end of the preview. Sign up to access the rest of the document.

Unformatted text preview: 1 INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE P RECLINICAL S AFETY E VALUATION OF B IOTECHNOLOGY-D ERIVED P HARMACEUTICALS S6 Recommended for Adoption at Step 4 of the ICH Process on 16 July 1997 by the ICH Steering Committee This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA. 1 P RECLINICAL S AFETY E VALUATION OF B IOTECHNOLOGY-D ERIVED P HARMACEUTICALS ICH Harmonised Tripartite Guideline Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 16 July 1997, this guideline is recommended for adoption to the three regulatory parties to ICH TABLE OF CONTENTS 1. Introduction .............................................................................................................. 1 1.1 Background .......................................................................................................... 1 1.2 Objectives............................................................................................................. 1 1.3 Scope..................................................................................................................... 1 2. Specification of the Test Material........................................................................ 2 3. Preclinical Safety Testing...................................................................................... 2 3.1 General principles ............................................................................................... 2 3.2 Biological activity/pharmacodynamics ............................................................... 3 3.3 Animal species/model selection........................................................................... 3 3.4 Number/gender of animals.................................................................................. 4 3.5 Administration/dose selection............................................................................. 4 3.6 Immunogenicity................................................................................................... 5 4. Specific Considerations.......................................................................................... 5 4.1 Safety pharmacology ........................................................................................... 5 4.2 Exposure assessment .......................................................................................... 6 4.2.1 Pharmacokinetics and toxicokinetics ........................................................ 6 4.2.2 Assays ......................................................................................................... 6 4.2.3 Metabolism ................................................................................................. 7 4....
View Full Document

This note was uploaded on 01/01/2012 for the course PHAR 6010 taught by Professor Mullis during the Spring '11 term at University of Georgia Athens.

Page1 / 13

International Conference on harmonisation of technical requirements for registration of pharmaceutic

This preview shows document pages 1 - 4. Sign up to view the full document.

View Full Document Right Arrow Icon
Ask a homework question - tutors are online