tailieunhanh - Intraocular Drug DelIvery (part 3)

Nhật Bản, và Hoa Kỳ. Mục đích của ICH là làm cho các khuyến nghị về cách để đạt được hài hòa hơn trong việc giải thích và áp dụng các hướng dẫn kỹ thuật và các yêu cầu đăng ký sản phẩm để giảm bớt hoặc phòng ngừa sự cần thiết phải lặp lại trong các thử nghiệm thực hiện trong quá trình nghiên cứu và phát triển các loại thuốc mới. | 60 Gryziewicz and Whitcup ICH is a project involving regulatory and industry representatives of the major pharmaceutical marketplaces in the world the European Union Japan and the United States. The purpose of ICH is to make recommendations on ways to achieve greater harmonization in the interpretation and application of technical guidelines and requirements for product registration in order to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines. The objective of such harmonization is a more economical use of human animal and material resources and the elimination of unnecessary delay in the global development and availability of new medicines while maintaining safeguards on quality safety and efficacy and regulatory obligations to protect public health 4 . The ICH has published a collection of guidelines attempting to standardize the requirements for establishing the safety efficacy and quality of pharmaceutical products. These guidelines currently have been adopted not only by the ICH participating countries the European Union Japan and the United States but also by countries that are monitoring the ICH process including Canada and Australia. DRUG DEVELOPMENT IN THE UNITED STATES As a result of increasing standardization of regulatory requirements for new drug approval global development is becoming more feasible. This chapter will review drug development in the United States as an example of the regulatory requirements for bringing a new drug to market. Prior to initiation of human studies with an investigational drug in the United States an Investigational New Drug IND application must be in effect with the FDA. An initial IND submission contains the study protocol the investigator s brochure the nonclinical animal cell culture etc. data that support the conduct of the clinical study and information on the manufacturing and control of the drug substance and the drug product 3 . The FDA has 30 days