The opportunity to write a truly international guideline on statistics is a rare one indeed. In 1995, the Steering Committee of the International Conference on Harmonisation1 (ICH) took a decision which was of major importance to all medical statisticians involved in the development of new medicinal products. This decision was to add a guideline on statistical methodology (E9) to the collection...

List of abbreviations 4 Introduction 5 The history and development of the new guideline ICH Topic Q8 5 The contents and requirements according to the new guideline 9 Comparison of the current guideline ICH Q8 with the previous guideline 15 Comparison of both guidelines – a summary 28 The term Design Space-Integration into ICH Q8, Q9 and Q10 29 Requirements of the new guideline for the innovatin...

This Comment argues that the parties to the International Conference on Harmonization of Technical Requirements for Regulation of Pharmaceutical Drugs (ITCH) should adopt more specific guidelines for pediatric research than those included in its Good Clinical Practice Guidelines (ICH GCP), and analyzes their attempt to do so in the Draft Guideline on Pediatric Trials. Part I of this Comment out...

ICH S7B guideline regulates the in vitro IKr assay in combination with in vivo QT evaluation prior to first-in-human administration. This guideline has been recommended for adoption by the regulatory bodies of 3 regions (Japan, USA and EU). To support compound development through cardiovascular safety assessment, Charles River Preclinical Services, Edinburgh (PCS-EDI) has developed and operates...

Since the inception of the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) in 1990, six-party Expert Working Groups (EWG) have developed and revised numerous guidelines on preclinical safety evaluation (Table 1). The six parties to ICH represent the regulatory bodies and pharmaceutical manufacturing organizations in...

Objective (s): This study aimed at investigation of preparation and stability study of Mitomycin and Mitomycin loaded nanoliposems and efficacy of the combination of Mitomycin -loaded nanoliposomes and Curcumin versus Mitomycin in suppressing HTB-9 and L929 cell lines, in vitro.Materials and Methods: An HPLC method was validated based on Q2 (R1) International Conference on Harmonization (ICH) g...

The Guideline for Good Clinical Practice (GCP) of the International Conference of Harmonisation (ICH) is an international standard for the ethical and scientific quality of the designing, conducting, recording and reporting of trials that involve the participation of human subjects. Today, most regulators and funding agencies follow the ICH guidelines. These were drawn up by a small number of r...

Status Last revised February 1996 Previous titles/other references Validation of Virus Removal and Inactivation Procedures (III/8115/89) / CPMP/BWP/268/95 Additional Notes This guideline discusses the need for, and the contribution of, viral validation studies towards the viral safety of biological products, providing guidance on the design of a validation study including the choice of viruses ...

Since 1991 the European Medicines Agency (EMA, formerly EMEA) adopted the Guidelines of the International Conference onHarmonization (ICH) onGoodClinical Practice (GCP). In this regard, one European Union (EU) Guideline and three EU Directives are in force at present, that is, the E6/CPMP/ICH/135/95 GCP Guideline, Directive 2001/83/EC (Community Codex on Pharmaceuticals), Directive 2001/20/ EC ...