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What are the Contents of the New Drug Preclinical Research?

 

Preclinical research content of new drugs:

  • Literature research (drug name and naming basis, title and basis)
  • Pharmaceutical research (raw material drug technology research, preparation prescription and technology research, etc.)
  • Pharmacology and toxicology research (general pharmacology experiment, main pharmacodynamic experiment, acute toxicity experiment, long-term toxicity experiment, etc.)

The stage and purpose of the clinical research of the new drug:

Phase I clinical trial (safety):

preliminary clinical pharmacology and human safety evaluation test. Observe the human body’s tolerance and pharmacokinetics of new drugs to provide a basis for formulating dosing regimens.

Phase II clinical trial (effectiveness):

the preliminary evaluation stage of the therapeutic effect. Its purpose is to preliminarily evaluate the therapeutic effect and safety of the drug on patients with target indications, and also to provide a basis for the design of phase III clinical trials and the determination of the dosage regimen.
The research design at this stage can adopt various forms according to specific research purposes, including randomized blinded controlled clinical trials.

Phase III clinical trial:

the stage of confirmation of the therapeutic effect. Its purpose is to further verify the therapeutic effect and safety of the drug on patients with target indications, evaluate the relationship between benefits and risks, and ultimately provide a sufficient basis for the review of drug registration applications. The test should generally be a randomized blinded controlled trial with sufficient sample size.

Phase IV clinical trials:

the application research phase of the new drug after it is marketed. Its purpose is to investigate the efficacy and adverse reactions of the drug under widely used conditions, to evaluate the relationship between benefits and risks in general or special populations, and to improve the dosage at the first level.
Bioequivalence test refers to the method of bioavailability research, using pharmacokinetic parameters as an indicator to compare the same or different dosage forms of the same drug, under the same test conditions, the absorption degree and speed of its active ingredients There are no statistical differences in human trials.

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Preclinical Drug Development Process

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