IJCCR_2024v14n1

International Journal of Clinical Case Reports 2024, Vol.14, No.1, 40-47 http://medscipublisher.com/index.php/ijccr 44 The selection of drugs is typically based on their sensitivity and inhibitory effects on specific gene mutations. Design drug combination therapy plans based on the characteristics of the target genes and drugs. This may involve the simultaneous or sequential use of multiple drugs to enhance efficacy, delay the development of resistance, or target multiple crucial pathways. After initiating treatment, regularly monitor the patient's response to treatment and drug tolerance. Based on monitoring results, adjust drug dosages, treatment plans, or introduce newdrugs. 2.3 Assessment of drug safety and effectiveness The assessment of drug safety and effectiveness is a comprehensive process involving multiple stages and various sources of data. These evaluations help ensure the safety and effectiveness of drugs in clinical practice, providing physicians and patients with reliable treatment options. The early stages of drug development typically include preclinical studies, such as in vitro experiments and animal experiments. These studies are conducted to assess the drug's biological activity, toxicity, metabolic pathways, and drug interactions, among other factors. The goal of preclinical studies is to obtain the initial safety and potential therapeutic effects of drugs. Clinical trials are a crucial step in assessing the safety and efficacy of drugs, divided into three phases: Phase I, Phase II, and Phase III. Phase I trials primarily assess the tolerability and pharmacokinetic properties of the drug in healthy volunteers. Phase II trials expand the sample size to evaluate the drug's efficacy and safety. Phase III trials are large-scale randomized controlled trials that assess the efficacy and safety of the drug in a large number of patients and compare it with existing treatments. The safety assessment of a drug refers to the evaluation of adverse reactions and side effects during its use. This includes assessing the impact of the drug on the human organ systems, drug tolerability, potential for drug abuse, and safety in specific populations such as children, pregnant women, and the elderly. Data for safety assessment comes from clinical trials, epidemiological studies, drug monitoring, and adverse event reports, among other sources. The assessment of drug effectiveness refers to evaluating the efficacy of a drug in treating the target disease or symptoms. Effectiveness assessment typically involves using clinical indicators, biomarkers, disease improvement, survival rates, etc., as measures. The assessment of drug effectiveness needs to be conducted in clinical trials, combining clinical experience and analysis of real-world clinical efficacy data. After a drug is on the market, continuous post-market monitoring is conducted to assess its long-term safety and effectiveness. This includes monitoring adverse event reports for the drug, drug interactions with other medications, and usage patterns in specific populations, among other factors. Through post-market monitoring, rare adverse reactions or other safety issues can be promptly discovered and identified, leading to appropriate actions. 3 Applications of Genome-Driven Personalized Drug Therapy 3.1 Cancer treatment Genome-driven personalized drug therapy plays a crucial role in cancer treatment. By analyzing the genomic information of a patient's tumor, key genes or pathways driving tumor development can be identified. Medications targeting these specific genetic abnormalities are then selected for treatment. Genome-driven personalized drug therapy provides cancer patients with more precise and targeted treatment strategies, improving treatment effectiveness while reducing unnecessary drug exposure and side effects. By analyzing the tumor genome, activating mutations in driver genes such as EGFR, HER2, BRAF, etc., can be identified. The abnormal activation of these genes promotes tumor growth and spread. Based on these findings, approved targeted drugs such as EGFR inhibitors, HER2 inhibitors, BRAF inhibitors, etc., can be used to treat these driver genes. This personalized treatment strategy can improve response rates and significantly enhance patient survival and quality of life (Russo et al., 2019; Mao and Liu, 2019).

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