浅谈药物之临床试验

• Purpose: Be designed to ensure that only those pharmaceutical products that are both safe and effective are brought to market.
About C来自百度文库inical Research (Cont.)
In General…..
• Clinical testing is usually described as consisting of Phase I, Phase II and Phase III clinical studies. • In each successive phase, increasing numbers of patients are tested.
About Clinical Research
• Clinical Research is Essential to New Drug Discovery and Development. • Through research, new drugs are tested for
– Effectiveness – Safety
• Only after all phases of research are complete can the Food and Drug Administration approve drugs for use by the general public.
About Drug Discovery and Development • • • • • • • • Pre-Clinical Stage (IND/CTX/CTA) Phase I 第一期之臨床試驗 Phase II 第二期之臨床試驗 Phase IIIa 第三期之臨床試驗 (NDA/MAA) Phase IIIb/IV 第四期之臨床試驗 Post-Marketing 藥品上市後之試驗
About Clinical Research (Cont.)
• The final phases of clinical research, involving patients with chronic or acute illness, follow years of research in the laboratory as well as testing of the drug in people who have no illnesses.
• Before a patient learns that a new drug is available for their condition, many patients have taken the drug on an investigational basis. • Patients who participate in clinical research help in the development of new treatments which help people to live longer and feel better.
What is Required before an Investigational Drug can be Tested in Human Volunteers?
• In Preclinical Stage of Drug Development
– An investigational drug (ID) must be tested extensively in the laboratory to ensure it will be safe to administer to humans. – Testing can take from 1 to 5 years – Must provide information about the drug
淺談藥物之臨床試驗
楊蕙瑛, M.S., RPh.
大綱
• • • • • 藥物之發展與研究 何謂臨床試驗 歷史緣由 醫學研究的倫理準則 試驗醫師之責任與義務
Quiz
• How long will it take? • Probability? • Profit? vs. Cost? • Luck vs. Effort?
Statistics
• New Drugs Begin in the Laboratory , Discovering and Bringing One New Drug to the public • Typically Costs a Pharmaceutical or Biotechnology Company Nearly $900 Million USD • Takes an Average of 10 to 12 Years • Out of Every 5,000 New Compounds Identified during the Discovery Process • Only 5 are Considered Safe for Testing in Human Volunteers after Preclinical Evaluations. • After 3 to 6 Years of Further Clinical Testing in Patients, Only 1 of these Compounds is Ultimately Approved as a Marketed Drug for Treatment.
• • • • Pharmaceutical Composition (e.g. PK) Safety How the drug will be formulated & manufactured How it will be administered to the first human subjects