Bioscience Method 2024, Vol.15, No.1, 37-49 http://bioscipublisher.com/index.php/bm 44 standards for the effectiveness and safety of drugs. The evaluation criteria mainly include pharmacodynamic evaluation, pharmacokinetic evaluation, and safety evaluation. Pharmacodynamic evaluation verifies whether a drug has the expected pharmacological effect through in vitro or in vivo experiments, ensuring that it matches the expected therapeutic effect. Pharmacokinetic evaluation focuses on the absorption, distribution, metabolism, and excretion processes of drugs in the body to predict their therapeutic effects and potential side effects. At the same time, by evaluating the potential toxicity, mutagenicity, carcinogenicity, and other aspects of the drug on the body, the safety of the drug is ensured. To meet these evaluation criteria, the selection of validation methods is crucial. In vitro experiments are one of the commonly used verification methods, which provide a basis for preliminary evaluation of drug efficacy and safety by simulating the process of drug action in the body under laboratory conditions. Animal experiments further validate the performance of drugs in animal bodies, including evaluations of acute toxicity, long-term toxicity, and pharmacodynamics (Abbasnezhad et al., 2022). Clinical trials are a crucial step in verifying the efficacy and safety of drugs in practical applications, gradually validating the effectiveness and safety of drugs through multiple stages of trials. The criteria and validation methods for evaluating candidate drugs are crucial steps in drug development, involving multiple techniques and analytical methods. Balbach and Korn (2004) discussed methods for evaluating candidate drugs in early drug development, emphasizing the importance of early evaluation of physicochemical parameters such as solubility, dissolution rate, hygroscopicity, lipophilicity, pKa, stability, polymorphism, and particle properties. They proposed a method that requires only up to 100 milligrams of drug substances for high-quality evaluation. Benson et al. (2006) discussed the importance of validating cancer drug targets by demonstrating that specific therapeutic drugs are effective in clinical practice and acting through their designed targets, although it is advisable to declare early drug targets as "validated" before entering a comprehensive drug discovery program. Plenge et al. (2013) described the use of naturally occurring human mutations that affect the activity of specific protein targets, which can be used to estimate the potential efficacy and toxicity of drugs targeting such proteins, as well as establish causal relationships between targets and outcomes rather than reactive relationships. The above examples emphasize the multifaceted approach from physical and chemical evaluation to clinical evaluation and validation of biological analysis methods, which is crucial for ensuring the safety, efficacy, and ultimate clinical application of candidate drugs. 4.2 Experimental design and animal model selection In drug development, experimental design and animal model selection not only directly affect the reliability and effectiveness of experimental results, but also determine the efficiency and cost of the drug development process. Experimental design requires comprehensive consideration of multiple factors, including experimental objectives, research questions, expected outcomes, and available resources and time. A good experimental design should be clear, repeatable, and able to accurately answer research questions. It is also necessary to consider factors such as variable control, sample size, data collection and analysis methods in the experiment to ensure the accuracy and reliability of the experimental results. For example, Silk et al. (2014) emphasized the importance of experimental design in model selection and parameter inference. Through experimental design and model selection framework based on random state space models, they demonstrated that the selected model may depend on the experiments performed. This indicates that the experimental design makes model selection a confidence criterion, but this is not necessarily related to the predictive power or correctness of the model. The selection of animal models is also an indispensable part of experimental design. Different types of animals have different physiological and pathological characteristics. In the process of drug development, how to enhance the reliability and efficiency of research through precise experimental design and appropriate animal model selection. The correct selection and use of animal models are crucial for understanding disease mechanisms, evaluating drug safety and efficacy, and ultimately achieving successful drug development.
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