International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Draft Consensus Guideline

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Ich Harmonised Tripartite Guideline Genotoxicity : a Standard Battery for Genotoxicity Testing of Pharmaceuticals

Protecting the rights of pediatric research subjects in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

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...

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Ich Harmonised Tripartite Guideline Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility S5(r2)

Bioanalytical method validation

A syntetic discussion on bioanalytical methods validation is presented from the point of view of regulatory documents, scientific articles and books. The validation parameters are described, together with an example of validation methodology applied in the case of chromatographic methods used in bioanalysis, taking in account to the recent Food and Drug Administration (FDA) guidelines and docum...

High Throughput Screening using Membrane Chromatography

Fig. 1: Steps during process development. HTPD as a first step can help to generate a large knowledge space and improve process understanding. That advances the quality-by-design concept regarding the FDA’s (Food and Drug Administration) initiative “PharmaceuticalcGMPs for the 21 century” and ICH International Conference on Harmonisation of technical requirements for the registration of pharmac...