New drug research and development is accompanied by high risks, high investment, and low returns. During this period, two important issues must be repeatedly verified:
Is it safe and effective? Pharmaceutical R&D workers need to conduct systematic research on drugs through various preclinical and clinical trials to reveal or confirm the effects of test drugs, adverse reactions, and drug absorption, distribution, metabolism and excretion in the body, and to determine the safety of test drugs Sex and effectiveness. In order to accurately measure the content of drugs and metabolites in the body, as well as to monitor biomarkers as indicators of disease progression, therapeutic intervention effects and drug activity, bioanalysis has become a vital part of the development of new drugs. The attention of regulators.
Bioanalysis is a tool discipline that plays the role of “eyes” in the entire drug development, providing reliable data for all stages of new drug development. Accurate data is the basis of all analysis. Inaccurate data can cause serious misleading effects, waste time and money, and even result in the rejection of drugs that could have been marketed.
In the development process of innovative drugs, it is necessary to gradually advance along the main line of safety, effectiveness, and controllable quality. Both preclinical and clinical research need to serve this main line. The data of various biological analysis methods support each other and form a chain of evidence. It reveals the law of action of drugs in the body and supports the launch of new drugs. In this process, a large number of unknown factors are doped in it. Incorporating inaccurate data, a factor that can actually be controlled, will not only be detrimental to cause analysis, but will also mislead decision makers and reviewers, which will seriously hinder the improvement of the quality of new drug research and evaluation in the long run.
Therefore, reliable bioanalysis method data is the key to drug discovery and development. The importance of bioanalysis in the clinical research of small molecule new drugs and the challenges of technology and project management are the hotspots of widespread concern in this field.
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