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5 de ene. de 2000 · Home. ICH Q6A specifications: test procedures and acceptance criteria for new drug substances and new drug products: chemical substances - Scientific guideline. Human Scientific guidelines. This document aims to assist in the establishment of a single set of global specifications for new drug substances and new drug products.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines.
14 de oct. de 2019 · The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety and reporting of clinical trials. It also covers novel types of medicines derived from biotechnological processes and the use of pharmacogenetics/ pharmacogenomics techniques to produce better targeted medicines.
The ICH Q2(R2) revised Guideline and the Q14 Guideline reached Step 4 of the ICH process on 1 November 2023. The Q2(R2)/Q14 EWG developed a new ICH Quality Guideline, ICH Q14, on Analytical Procedure Development, and revised the ICH Q2(R1) Guideline on Validation of Analytical Procedures.
9 de ene. de 1998 · This document provides guidance on the design, conduct, analysis and evaluation of clinical trials of an investigational product in the context of its overall clinical development. It also assists with preparing application summaries or assessing evidence of efficacy and safety, principally from clinical trials in later phases of development.
Website. www.ich-und-ich.de. Gründungsmitglieder. Gesang, Keyboard. Annette Humpe. Gesang, Mundharmonika. Adel Tawil. Ich + Ich (gesprochen ich und ich) ist ein deutsches Popmusikprojekt, das aus den Musikern Annette Humpe und Adel Tawil besteht.
