Protecting the rights of pediatric research subjects in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.
نویسنده
چکیده
This Comment argues that the parties to the International Conference on Harmonization of Technical Requirements for Regulation of Pharmaceutical Drugs (ITCH) should adopt more specific guidelines for pediatric research than those included in its Good Clinical Practice Guidelines (ICH GCP), and analyzes their attempt to do so in the Draft Guideline on Pediatric Trials. Part I of this Comment outlines the genesis of the current international guidelines for human research and how they relate to pediatric subjects. Part I also explains the human research guidelines of the three principal members of the ICH. Part II describes the function of the ICH and the provisions of the ICH GCP. Part II also discusses how the ICH GCP addresses pediatric medical research issues, and the provisions of the new Draft Guideline on Pediatric Trials. Part III argues that the Draft Guideline on Pediatric Trials represents a significant improvement in pediatric research guidelines, and should be accepted by the parties to the ICH with some modifications regarding the subject’s consent and the role and composition of international review boards. PROTECTING THE RIGHTS OF PEDIATRIC RESEARCH SUBJECTS IN THE INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE
منابع مشابه
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Draft Consensus Guideline
متن کامل
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Ich Harmonised Tripartite Guideline Genotoxicity : a Standard Battery for Genotoxicity Testing of Pharmaceuticals
متن کامل
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Ich Harmonised Tripartite Guideline Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility S5(r2)
متن کامل
Matrix-mini-tablets of lornoxicam for targeting early morning peak symptoms of rheumatoid arthritis
Objective(s): The aim of present research was to develop matrix-mini-tablets of lornoxicam filled in capsule for targeting early morning peak symptoms of rheumatoid arthritis. Materials and Methods:Matrix-mini-tablets of lornoxicam were prepared by direct compression method using microsomal enzyme dependent and pH-sensitive polymers which were further filled into an empty HPMC capsule. To asses...
متن کاملBioanalytical method validation
A syntetic discussion on bioanalytical methods validation is presented from the point of view of regulatory documents, scientific articles and books. The validation parameters are described, together with an example of validation methodology applied in the case of chromatographic methods used in bioanalysis, taking in account to the recent Food and Drug Administration (FDA) guidelines and docum...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید
ثبت ناماگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید
ورودعنوان ژورنال:
- Fordham international law journal
دوره 23 3 شماره
صفحات -
تاریخ انتشار 2000