ABSTRACT
The three main pillars of drug evaluation are quality, safety and efficacy. Each marketing authorization dossier has to demonstrate conformity with quality, safety and efficacy requirements separately. While this is justifiable, it may nevertheless lead to some important problems being overlooked. The relationship between these three aspects of a medicinal product can be of great importance. Little is said about how quality can affect safety or even efficacy. It is worth discussing these connections in order to assess side-effects appropriately and to distinguish between quality failures and real pharmacovigilance problems. Not every side-effect is a result of the drug's pharmacodynamic or pharmacokinetic properties or other therapy-related issues such as interactions. Sometimes a patient complaint is caused by substandard quality of the drug. This possibility should never be ignored in any assessment of side-effects. This paper presents a useful check-list of quality failures that can endanger drug safety.
Subject(s)
Drug Industry/standards , Drug-Related Side Effects and Adverse Reactions , Pharmaceutical Preparations/standards , Quality Control , Chemistry, Pharmaceutical , Drug Contamination/legislation & jurisprudence , Guidelines as Topic , Legislation, Drug , Safety , Solvents/adverse effectsABSTRACT
Systematic review of literature coupled with integrative research of published data for triazole antifungal agents was done. The investigated literature covered chromatographic and electrophoretic methods developed in the last 10 years (2000-2009). The aim of this review was to compare different methodologies, assess preferences in the selection of analytical methods and to find still existing analytical problems. Last decade is characterized by dynamic development of instrumental methods, that results in advance and diversity of applied analytical procedures. The main focus was given to high-performance liquid chromatography (HPLC), the technique of choice in the analysis of most of pharmaceuticals. The review includes literature on 8 triazole antifungal drugs: fluconazole, itraconazole and terconazole from the first generation and posaconazole, voriconazole, ravuconazole, isavuconazole and albaconazole classified in second generation. Investigations of pharmaceutical formulations and biological samples were considered.
