FDA Drugs for Treatment of Partial Onset Seizures Full Extrapolation of Efficacy from Adults to Pediatric Patients 2 Years of Age and Older
标准简介
Drugs for Treatment of Partial Onset Seizures Full Extrapolation of Efficacy from Adults to Pediatric Patients 2 Years of Age and Older[附网盘链接]是于之前发布的FDA标准，适用于US。标准截图
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标准文档说明
标准文档类型为Drugs for Treatment of Partial Onset Seizures Full Extrapolation of Efficacy from Adults to Pediatric Patients 2 Years of Age and Older[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
Drugs for the Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 2 Years of Age and Older 1
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 provides recommendations to sponsors on the clinical development of drugs for the treatment of partial onset seizures (POS) in pediatric patients. Specifically, this guidance addresses FDA’s current thinking regarding clinical development programs that can support extrapolation of the efficacy of drugs approved for the treatment of POS in adults to pediatric patients 2 years of age and older. This guidance does not address clinical development programs for the treatment of POS in pediatric patients younger than 2 years of age. This guidance does not address the development of drugs to treat other types of seizures. 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. II. BACKGROUND Historically, because evidence to support an extrapolation approach was not available, FDA has required, under section 505(d) of the Federal Food, Drug, and Cosmetic Act, that sponsors establish efficacy for the treatment of POS in pediatric patients by performing one or more adequate and well-controlled clinical studies in pediatric patients. The doses in these pediatric studies were generally based on body weight and age, in an effort to attain blood concentrations similar to those found to be effective in adults. Selection of doses was also informed by safety and tolerability data from open-label studies in the pediatric population. 1
This guidance has been prepared by the Division of Neurology Products and the Division of Clinical Pharmacology I in the Center for Drug Evaluation and Research at the Food and Drug Administration.
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