Methodology of drug development based on "hypothesis verification" theoretical framework
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Hypothesis is an important step of scientific cognition and a form of scientific development.

It is generally believed that the development of scientific theories must go through the stage of hypothesis, and all advance in the form of hypothesis and develop into scientific theories. In addition, hypothesis is widely used not only in natural science, but also in social science. The "hypothesis verification" theoretical framework has gradually become a research paradigm of natural science or social science.


The discovery and solution of many problems and the formation of theories depend on the proposition of assumptions. The formation of assumptions is the process of raising questions. Sometimes raising questions is more important than solving problems. The formation of hypothetical thinking is conducive to raising good questions. Such as the hypothesis of atomic structure in physics. The hypothesis about ionization in chemistry and the hypothesis about the process of chlorophyll generation in biology, the above theories, at the beginning, put forward questions in the form of hypothesis, and started from the hypothesis. If the hypothesis is verified, the theory is formed. If the hypothesis is proved to be invalid, the hypothesis is false.


The proposition of hypothesis is to form a logical starting point for subsequent research activities, that is, the subsequent experiment is conducted on the premise of hypothesis. If the conclusion of the experiment validates the hypothesis, the hypothesis is valid. If it contradicts the hypothesis, the hypothesis is not valid. This is the basic principle of the hypothesis verification theoretical framework.


The basic idea of hypothesis test in statistics is to make the original hypothesis first, then take the original hypothesis as the precondition (that is, the original hypothesis is true), and use the parameter as the variable to calculate the probability. If the P value is less than 0.05, that is, the probability of occurrence when the original hypothesis is true is a small probability event, that is, the original hypothesis cannot occur, and the hypothesis is not tenable. vice versa.


In venture capital Many of our investment methodologies also use the idea of "hypothesis verification", such as assumptions about business models and target customers, and then verify them in a small range. If the verification is successful, they can be replicated in a large scale. If validation fails, re assume validation.


About the The "hypothesis verification" theory is mostly used for new drugs (505 (b) (1)) and improved new drugs (505 (b) (2)). The methodological step is to first make assumptions (that is, ask questions), and then carry out experiments to verify the assumptions.

Assumptions in drug development New drug development is usually a new target/mechanism/pathway/new molecular entity that has an effect on an indication and can meet the unsatisfied clinical needs. Then, take the assumption as a logical starting point, design tests, such as synthesis, select lead compounds for action tests, and clinical trials to verify whether it is effective and safe. The assumption of improved new drugs is generally to improve effectiveness/safety, improve compliance, and then design tests, that is, the process of forming evidence, to verify whether the assumption is valid.




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