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FDA certification of pharmaceutical products
Source: ShenZhenTobyTechnologyCo.,LtdPopularity: 1650Time: 2016-04-18【SMB】
FDA certification of pharmaceutical products FDA has a complete set of procedures for medical products to ensure the safety and effectiveness of the new drug:
1, the research of new drug trial (IND):
When pharmaceutical company submitted to the FDA ind, FDA's monitoring of new drugs began. At this time human trials of new drugs has not yet started, FDA review of the main body of safety data and experimental data to decide the drug is safe enough to enter the stage of human experiments.
2 human body experiment:
The experiment is divided into 4 stages: the primary safety test drug issue, the main side effects, metabolic mechanism, the number of samples is generally less than the effectiveness of the two phase of the 200 major drug test, to determine whether the drug can effectively act on the human body. At the same time, the object of drug safety and toxicity is closely to observe the number of samples. Two experimental period is generally less than 300 if the two phase of the study are encouraging larger sample preparation test, experiment to enter the three phase. The three phase will include different ages, different populations with different dosage on the comprehensive research of the safety and effectiveness of drugs the number of samples. Three experiments in several hundred to several thousand dollars. The four mainly in drug approval for long-term safety testing, the main drugs, the new population.
3 new drug application (NDA):
When pharmaceutical companies completed the human experiments to verify the safety and effectiveness of new drugs, the official to the FDA NDA submission for the FDA to review all animal and human experiment data, and drug generation mechanism solution data, drug GMP data, if the data is not complete and reasonable, FDA will refuse to Shen Li, or the FDA will in 10 months or so explain nucleus is completed, to give consent or refuse to listen.
1, the research of new drug trial (IND):
When pharmaceutical company submitted to the FDA ind, FDA's monitoring of new drugs began. At this time human trials of new drugs has not yet started, FDA review of the main body of safety data and experimental data to decide the drug is safe enough to enter the stage of human experiments.
2 human body experiment:
The experiment is divided into 4 stages: the primary safety test drug issue, the main side effects, metabolic mechanism, the number of samples is generally less than the effectiveness of the two phase of the 200 major drug test, to determine whether the drug can effectively act on the human body. At the same time, the object of drug safety and toxicity is closely to observe the number of samples. Two experimental period is generally less than 300 if the two phase of the study are encouraging larger sample preparation test, experiment to enter the three phase. The three phase will include different ages, different populations with different dosage on the comprehensive research of the safety and effectiveness of drugs the number of samples. Three experiments in several hundred to several thousand dollars. The four mainly in drug approval for long-term safety testing, the main drugs, the new population.
3 new drug application (NDA):
When pharmaceutical companies completed the human experiments to verify the safety and effectiveness of new drugs, the official to the FDA NDA submission for the FDA to review all animal and human experiment data, and drug generation mechanism solution data, drug GMP data, if the data is not complete and reasonable, FDA will refuse to Shen Li, or the FDA will in 10 months or so explain nucleus is completed, to give consent or refuse to listen.
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