FDA药物审批流程
THE DRUG DEVELOPMENT AND APPROVAL PROCESS IN THE US
The Food and Drug Administration (FDA) regulates the development of novel drugs. Both prescription and over-the-counter drugs are regulated by the Center for Drug Evaluation and Rearch (CDER). CDER has been established to ensure that drug products are safe and effective. All new drug products must undergo a rigorous process of pre-clinical and clinical evaluation. According to a 1999 report from PhRMA, it takes 15 years and $500 million for an experimental drug to travel from the lab bench to the patient. For every 5000 compounds that enter pre-clinical testing, only five will continue on to clinical trials in humans and only one will be approved for marketing in the United States. After each stage of development, the sponsor of the new product meets with the FDA to determine next steps and establish end points for future trials. Similar process are required in other countries.
Preclinical Testing. A pharmaceutical or biotechnology company conducts laboratory and an
imal studies to demonstrate biological activity of the compound against the targeted dia, and the compound is evaluated for safety.
Investigational New Drug Application (IND). After completing preclinical testing, the company files an IND with the FDA to begin to test the drug in humans. The IND becomes effective if the FDA does not disapprove it within 30 days. The IND shows
results of previous experiments and studies; how, where and by whom the new studies will be conducted; the chemical structure of the compound; how it is thought to work in the body; any toxic effects found in the animal studies; and how the compound is
manufactured. The IND must be reviewed and approved by the Institutional Review Board (IRB) where the studies will be conducted, and progress reports on clinical trials must be submitted to the FDA at least once annually.
Pha I Human Clinical Trials. The tests involve approximately 20 to 80 normal, healthy volunteers. The tests study a drug’s safety profile , including the safe dosage ra
蜡尸nge. The studies also analy how a drug is absorbed, distributed, metabolid and excreted, and the duration of its action.
Pha II Human Clinical Trials. Controlled studies of approximately 100 to 300 volunteer patients (people with dia being treated) to asss the drug’s effectiveness and further analy safety. Do ranges may also be analyd during Pha II studies. More than one Pha II study may be conducted.
Pha III Clinical Trials. Approximately 1,000 to 3,000 patients in clinics and hospitals. This pha is ud to determine whether the drug’s effectiveness is statistically significant. Patients are continuously monitored for safety or adver reactions. Typically, more than one Pha III study is conducted.
工作分析调查问卷New Drug Application (NDA). Following successful completion of all three phas of human clinical trials, the company analys all of the data and files an NDA with the FDA if the data successfully demonstrate safety and effectiveness. The NDA must contain all of the scientific information that the company has gathered on the compound. NDAs can 关于海洋的手抄报
exceed 100,000 pages or more. By legislation, the FDA is allowed six months to review an NDA filing. In 2000, the average review time for approved products was 16 months. FDA Panel Review . Once CDER has reviewed the NDA, the product's sponsor prents the data to a panel of experts. The members of the panel may ask for clarification of specific data points, request explanations for certain outcomes or events obrved in the trial or po questions on potential issues that may occur if the product is approved for marketing. The members of the panel then vote in favour of or against recommending marketing approval. While the FDA does not have to take the recommendation of the panel, it usually does.
FDA Approval . Once the Review Panel has issued its recommendation, the FDA makes the final decision on product approval. Marketing of the drug is then permitted.
Human Clinical Trials
Early
卡通壁纸高清Rearch/Preclinical
而智勇多困于所溺一个齿一个且Testing Pha I Pha II Pha III FDA Review Process Pha IV Years 6 1 2.0 3.5
2 Test Population Laboratory & animal
studies 20 to 80 healthy volunteers 100 to 300 patient volunteers 1,000 to 3,000 patient volunteers Purpo
Asss Safety and biological activity Determine safety and dosage
Evaluate dosage, effectiveness, side effects
Confirm effectiveness, monitor long-term adver reactions
Review Process & Approval
Success Rate 5,000 compounds evaluated
FILE IND WITH FDA
5 enter human trials
FILE NDA WITH FDA
1 approved
15
years
血腥图片total Additional
post-marketing monitoring and testing required by FDA
