Guidelines from the International Conference on Harmonisation (ICH).
This article describes the development of international guidance on registration of technical dossiers supporting applications to market medicinal products. Aspects of guidance of particular relevance to the use of NMR spectroscopy in drug development and control are discussed.
Branch
Sarah K
SK
Medicines and Healthcare Products Regulatory Agency (MHRA), Market Towers, 1 Nine Elms Lane, London SW8 5NQ, UK.
D003226:Congresses as Topic; D004340:Drug Contamination; D004341:Drug Evaluation / Q000592:standards*; D017408:Guidelines as Topic; D007391:International Cooperation; D009682:Magnetic Resonance Spectroscopy; D004364:Pharmaceutical Preparations / Q000032:analysis* / Q000592:standards
D004364:Pharmaceutical Preparations