ICH's mission is to make recommendations towards achieving greater harmonisation in the interpretation and application of technical guidelines and requirements for pharmaceutical product registration, thereby reducing or obviating duplication of testing carried out during the research and development of new human medicines. Harmonisation is achieved through the development of ICH Tripartite Guidelines. The Guidelines are developed through a process of scientific consensus with regulatory and industry experts working side-by-side. Key to the success of this process is the commitment of the ICH regulators to implement the final Guidelines. This ICH Q8 Guideline has proven to be an important base for Pharmaceutical Development. Recommendations are given on both methodology and documentation of development activities. It introduces concepts like QTPP (Quality Target Product Profile), CQA (Critical Quality Attributes), CPP (Critical Process Parameters), Design Space and DoE (Design of Experiments.)
Reihe
Sprache
Verlagsort
Zielgruppe
Für Beruf und Forschung
Source of the original document: European Medicines Agency. No liability is assumed for correct transscript of the official text. 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.
Editions-Typ
Maße
Höhe: 14.7 cm
Breite: 10.5 cm
Gewicht
ISBN-13
978-3-945159-05-7 (9783945159057)
Schweitzer Klassifikation
