FDA CVM GFI #237 Oncology Drugs for Companion Animals
标准简介
CVM GFI #237 Oncology Drugs for Companion Animals[附网盘链接]是Food And Drug Administration于当前发布的FDA标准，适用于United States。标准截图
![CVM GFI #237 Oncology Drugs for Companion Animals[附网盘链接]](/img/20210914103703rms2z.jpg)
标准文档说明
标准文档类型为CVM GFI #237 Oncology Drugs for Companion Animals[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Oncology Drugs for Companion Animals
Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page. I. INTRODUCTION This guidance document makes recommendations to sponsors of investigational oncology drugs for use in companion animals (e.g., dogs, cats, and horses). The guidance discusses the contents of the target animal safety, effectiveness, and labeling technical sections of a new animal drug application (NADA) for oncology drugs administered as single agents. This guidance also includes recommendations on how to address human user safety concerns. For multi-drug regimens, we recommend that you contact the Center for Veterinary Medicine (CVM) to discuss your product development plan. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. You may follow the guidance document or may choose alternate pathways for approval. We recommend that you discuss your proposed study plans with CVM, especially if you choose to use an alternative pathway for approval. We encourage you to schedule a presubmission conference with CVM as you begin to make your investigational plans to ensure that you are completely informed on the requirements contained in the statute and regulations. II. EFFECTIVENESS
A. Dosage Characterization
D
osage characterization includes information on the dose or dose range, route of administration, dosing interval, dosing duration, and evidence that the proposed dosage has an effect on the tumor type in the target species. Dosage characterization is submitted in the Effectiveness technical section and is included in the Freedom of Information (FOI) Summary. For drugs administered based on body surface area (mg/m2), dose exposure may need to be considered separately for smaller animals (e.g., ≤10 kg) based upon the drug product and pharmacokinetic profile. Smaller animals may have higher drug exposure compared
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