| 药物研发 | Drug Development |
| 从药物发现到上市的完整研究和开发过程 | The full research and development process from drug discovery to market approval |
| 临床前试验 | Preclinical Trials |
| 在人体试验前进行的药物安全性和有效性测试 | Safety and efficacy tests conducted before human trials |
| 药代动力学 | Pharmacokinetics (PK) |
| 研究药物在体内吸收、分布、代谢和排泄的过程 | The study of drug absorption, distribution, metabolism, and excretion in the body |
| 药效动力学 | Pharmacodynamics (PD) |
| 研究药物如何作用于人体的机制和效果 | The study of how drugs act on the body and their effects |
| 一期临床试验 | Phase I Clinical Trials |
| 评估药物在健康志愿者中的安全性和剂量范围 | Evaluating the safety and dosage range of a drug in healthy volunteers |
| 二期临床试验 | Phase II Clinical Trials |
| 在小规模患者中测试药物的疗效和安全性 | Testing drug efficacy and safety in a small patient group |
| 三期临床试验 | Phase III Clinical Trials |
| 在大规模患者中评估药物的安全性和疗效 | Evaluating drug safety and efficacy in a large patient population |
| 四期临床试验 | Phase IV Clinical Trials |
| 药物上市后的长期疗效和安全性监测 | Long-term monitoring of a drug's efficacy and safety post-market |
| 双盲试验 | Double-Blind Study |
| 研究人员和参与者都不知道分配的治疗方案 | Neither the researchers nor the participants know the treatment allocation |
| 安慰剂效应 | Placebo Effect |
| 使用无效治疗后出现的积极心理和生理反应 | Positive psychological and physiological responses to an ineffective treatment |
| 生物等效性 | Bioequivalence |
| 两种药物在吸收率和作用效果上的相似性 | Similarity between two drugs in absorption rate and effect |
| 生物制药 | Biopharmaceuticals |
| 使用生物技术生产的治疗性蛋白质和核酸药物 | Therapeutic proteins and nucleic acid drugs produced using biotechnology |
| 基因治疗 | Gene Therapy |
| 通过更改或修复基因治疗疾病的方法 | Methods to treat diseases by modifying or repairing genes |
| 单克隆抗体 | Monoclonal Antibodies |
| 针对特定靶标制备的抗体用于治疗或诊断 | Antibodies prepared for specific targets used in therapy or diagnostics |
| 疫苗开发 | Vaccine Development |
| 通过引发免疫反应来预防疾病的研究和开发 | Research and development to prevent diseases by inducing immune responses |
| 临床药理学 | Clinical Pharmacology |
| 研究药物在人体中的作用和代谢方式 | The study of drug actions and metabolism in humans |
| 个性化医学 | Personalized Medicine |
| 根据患者的遗传背景和特性制定定制化治疗方案 | Tailoring treatment plans based on a patient’s genetic background and characteristics |
| 药物递送系统 | Drug Delivery Systems |
| 增强药物吸收和靶向性的技术和设备 | Technologies and devices to enhance drug absorption and targeting |
| 缓释制剂 | Sustained-Release Formulation |
| 控制药物释放速率以延长疗效的药剂形式 | Formulations that control drug release rates to prolong efficacy |
| 药物相互作用 | Drug-Drug Interactions (DDI) |
| 两种或多种药物同时使用时的相互影响 | Interactions occurring when two or more drugs are used together |
| 药物警戒 | Pharmacovigilance |
| 监测药物的安全性并预防药物相关风险 | Monitoring drug safety and preventing drug-related risks |
| 医药法规 | Pharmaceutical Regulations |
| 规范药物开发、生产、分销和使用的法律和规则 | Laws and rules governing drug development, production, distribution, and use |
| 国际协调会议 | International Council for Harmonisation (ICH) |
| 制定全球统一药物法规和技术要求的组织 | An organization establishing globally harmonized drug regulations and technical requirements |
| 化合物筛选 | Compound Screening |
| 在实验室中测试化学物质的药效和毒性 | Testing the efficacy and toxicity of chemical substances in the laboratory |
| 药物专利保护 | Drug Patent Protection |
| 确保药物创新和研发投资的法律保护措施 | Legal protections to ensure innovation and investment in drug R&D |
| 新药申请 | New Drug Application (NDA) |
| 向监管机构提交的药物批准申请文件 | A drug approval application submitted to regulatory authorities |
| 药物质量控制 | Drug Quality Control |
| 确保药物符合安全性和有效性标准的流程 | Processes to ensure drugs meet safety and efficacy standards |
| 中药现代化 | Modernization of Traditional Chinese Medicine (TCM) |
| 运用现代科学方法研究和开发中药 | Using modern scientific methods to research and develop traditional Chinese medicine |
| 药品市场准入 | Market Access for Drugs |
| 药物获得监管批准后进入市场的流程和策略 | Processes and strategies for drugs to enter the market post-regulatory approval |
| 临床数据管理 | Clinical Data Management (CDM) |
| 收集、存储和分析临床试验数据的过程 | The process of collecting, storing, and analyzing clinical trial data |
| 药品价格谈判 | Drug Pricing Negotiation |
| 政府或机构与制药公司之间的药品价格协商过程 | The negotiation process for drug pricing between governments or institutions and pharmaceutical companies |
