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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What is preclinical testing?

In the process of preclinical testing of a compound or biological agent into a drug, the compound involved must go through the testing phase. First, we need to identify potential targets that can treat the disease. Then, a variety of compounds or preparations are screened out. Any compound that has shown potential as a drug for the treatment of this disease needs to be tested for toxicity before clinical testing to reduce the possibility of injury. preclinical testing What is the basis of preclinical testing? According to US Food and Drug Administration (FDA) regulations, a series of tests are required before a new drug is approved for use. In the first stage, basic research determines a hypothetical target for the treatment of a certain disease, and then screens small molecules or biological compounds to discover any substance with the potential to treat the disease. Then, a preclinical research phase followed, before which, as described above, the potential toxicity of the compou

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Inventory of the three major in vitro pharmacokinetic research methods

The metabolic properties of a compound are an essential factor in whether or not it can be used as a drug in the clinical setting, so pharmacokinetic studies of newly synthesized compounds are required in drug development. In vitro incubation with liver microsomes, recombinant CYP450 enzyme lines, and in vitro incubation with hepatocytes are some of the more common in vitro drug metabolism methods. 1. In vitro incubation method with liver microsomes The metabolic stability and metabolic phenotypes of candidate compounds in different species of liver microsomes are good predictors of the metabolic properties of compounds in vivo. They are practical tools for evaluating candidate compounds in the pre-development phase of drug development. Liver microsomes include rat liver microsomes, human liver microsomes, canine liver microsomes, monkey liver microsomes, and mouse liver microsomes. In in vitro incubation of the liver, microsomes are the "gold standard" for in vitro d

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Novel Parkinson’s Therapies Possible with New Mouse Model

Parkinson's disease (PD) is a neurodegenerative disorder that is marked by the accumulation of the protein, α-synuclein (αS), into clumps known as Lewy bodies, which diminish neural health. Now, researchers from Brigham and Women's Hospital (BWH) report the development of a mouse model to induce PD-like αS aggregation, leading to resting tremor and abnormal movement control. The mouse responds to L-DOPA, similarly to patients with PD. The team's study (“Abrogating Native α-Synuclein Tetramers in Mice Causes a L-DOPA-Responsive Motor Syndrome Closely Resembling Parkinson’s Disease”) on the use of this transgenic mouse model appears in Neuron . “α-Synuclein (αS) regulates vesicle exocytosis but forms insoluble deposits in PD. Developing disease-modifying therapies requires animal models that reproduce cardinal features of PD. We recently described a previously unrecognized physiological form of αS, α-helical tetramers, and showed that familial PD-causing missense mutati

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