新藥發展的過程

新藥的發展是一條艱辛的路，除投入龐大的力、財力、時間之外，尚需背負著研發可能失敗的壓力，一般大藥廠在選題研究上絕對是小心。有關新藥研發所需的各種試驗數據資料處理等，美國藥物食品檢驗局多所規範，本文係站在藥廠的層面，針對新藥研發的實務面，就人力、經費、時間、選題、研發活動等部份所涉及與所需採取的步驟提出說明與探討。

關鍵字

新藥發展；美國

並列摘要

New drug discovery is a time-consuming work. Even a lot of manpower and financial support is input in the discovery, the result of drug discovery might not be achieved. So, it needs to be careful on the selection of a potential new molecular entity for investigation in the famous pharmaceutical companies. The regulations of new drug approval process in the U.S. have been compiled in the U.S. Code of Federal Regulations. The FDA publishes many guidelines to provide pharmaceutical industry with informal guidance on specific methods through which FDA requirements can be satisfied. This paper will focus on the efficient way of managing the drug discovery on the side of the pharmaceutical industry.

並列關鍵字

new drug discovery ； U.S.

國際替代計量

新藥發展的過程

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