کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
3418472 1225514 2006 10 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Medical treatment of echinococcosis under the guidance of Good Clinical Practice (GCP/ICH)
موضوعات مرتبط
علوم زیستی و بیوفناوری ایمنی شناسی و میکروب شناسی انگل شناسی
پیش نمایش صفحه اول مقاله
Medical treatment of echinococcosis under the guidance of Good Clinical Practice (GCP/ICH)
چکیده انگلیسی

Chemotherapy is one of the main components for the treatment of alveolar and cystic echinococcosis. Benzimidazoles are on the market since 30 years, and are used widely according to the recommendations of the 1996 WHO guidelines for treatment of cystic and alveolar echinococcosis [Bull WHO 1996; 74: 231–242.]. However, none of the two drugs (Albendazole or Mebendazole) would satisfy today the requirements for an approval by the relevant authorities, such as the European Agency for the Evaluation of Medicinal Products (EMEA) or the Food and Drug Administration (FDA). New anthelmithic drugs are in the pipeline, and some of them have already undergone preclinical testing. In addition, recent advances have been made in the definition of outcomes for clinical trials in alveolar echinococcosis. Thus, phase III studies with new active ingredients are needed to assess short- and long-term safety as well as the therapeutic value. The basic requirements for comparative drug testing are provided in the Note for Guidance on Good Clinical Practice (GCP), and are based upon the rules and regulations by International Conference on Harmonization (ICH) and the Clinical Trial Directive (Directive 2001/20/EC) of the European Commission. The application of these standards to new drug testing for echinococcosis will help to upgrade the level of evidence.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Parasitology International - Volume 55, Supplement, 2006, Pages S273–S282
نویسندگان
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