2. Analytical techniques
The above points underline the importance of detecting and characterizing falsified medicines, in order to assess the public health risks involved. The efficacy, safety and quality of medicines must therefore be assured. A large number of analytical techniques are available to drug analysis laboratories. They are all likely to provide information that can reveal the falsification of a sample, and their performance must be in line with the challenges of testing.
This chapter describes the techniques most commonly used in this field. They are classified by family and scientific complexity, including techniques performed in the laboratory or in the field. These analyses may first be carried out on the sample packaging, before being applied to the drug itself. They provide several levels of information on the quality of the drug and, when compared with a reference sample,...
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Analytical techniques
Bibliography
- (1) - - http://www.who.int/mediacentre/factsheets/ fs275/en/ (page consultée le 7 septembre 2016).
- (2) - -
Websites
Agence nationale de sécurité du médicament et des produits de santé (ANSM) http://ansm.sante.fr/Activites/Falsifications-de-produits-de-sante/ La-lutte-contre-la-contrefacon/(offset)/7 (page consulted on September 7, 2016)
Council...
Standards and norms
- Impurities : Guideline for Residual Solvents - ICH Q3C(R5) - 2011
Regulations
Law no. 83-634 of July 13, 1983 on the rights and obligations of civil servants. Law known as the Le Pors Law (consolidated version of March 3, 2002).
Directive 2011/62/EU of the European Parliament and of the Council of June 8, 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use as regards the prevention of the entry into the legal supply chain of...
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