Personalized medicine has many definitions. This term is often used synonymously with precision medicine, which is defined as the classifying patients with a disease or condition based on their phenotypic findings, such as biomarkers or genomics, into subpopulations that differ in their response to a specific treatment. Personalized medicine, however, can also mean the treatment of individual patients based on many contextual factors, such as response to therapy and patient preferences, in addition to predefined phenotypic findings. Regulatory approval for the marketing of a new drug or a new indication for a marketed drug requires a positive benefit risk profile and substantial evidence of effectiveness. The indication is based on the eligibility criteria and outcomes of the clinical trial(s) underpinning the regulatory approval. For precision medicine, drugs are often developed with companion diagnostics that are necessary for selection of the subgroup of patients, in contrast to personalized medicine which may be directed at a single patient. Most drugs are approved with a fixed dosage regimen for the approved population, but some drugs and biologics are approved with instructions to tailor therapy for individual patients, whether it be dosing, combination with other therapies, or selection among a class of medications. Hence, more often than not, personalized medicine directed at individual patients is achieved through the practice of medicine rather than regulatory action.

中文翻译：

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个性化生殖医学：监管考虑

个性化医疗有很多定义。该术语通常与精准医学同义使用，精准医学定义为根据表型发现（例如生物标志物或基因组学）将患有疾病或病症的患者分类为对特定治疗的反应不同的亚群。然而，个性化医疗也可能意味着基于许多背景因素对个体患者进行治疗，例如对治疗的反应和患者偏好，以及预定义的表型发现。新药上市的监管批准或上市药品的新适应症需要积极的利益风险概况和实质性的有效性证据。该适应症基于支持监管批准的临床试验的资格标准和结果。对于精准医疗，与可能针对单个患者的个性化医疗相比，药物通常与伴随诊断一起开发，这是选择患者亚组所必需的。大多数药物在获批时采用固定剂量方案，适用于获批人群，但一些药物和生物制剂获批时附有针对个体患者定制治疗的说明，无论是剂量、与其他疗法的组合，还是在一类药物中的选择。因此，针对个体患者的个性化医疗通常是通过医学实践而不是监管行动来实现的。与可能针对单个患者的个性化医疗相反。大多数药物在获批时采用固定剂量方案，适用于获批人群，但一些药物和生物制剂获批时附有针对个体患者定制治疗的说明，无论是剂量、与其他疗法的组合，还是在一类药物中的选择。因此，针对个体患者的个性化医疗通常是通过医学实践而不是监管行动来实现的。与可能针对单个患者的个性化医疗相反。大多数药物在获批时采用固定剂量方案，适用于获批人群，但某些药物和生物制剂获批时附有针对个体患者定制治疗的说明，无论是剂量、与其他疗法的组合，还是在一类药物中的选择。因此，针对个体患者的个性化医疗通常是通过医学实践而不是监管行动来实现的。