FDA Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials
标准简介
Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials[附网盘链接]是于不久之前发布的FDA标准，适用于US。标准截图
![Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials[附网盘链接]](/img/2021091410362914ty2.jpg)
标准文档说明
标准文档类型为Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials[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
Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials 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 The purpose of this guidance is to provide the pharmaceutical industry, clinical investigators, and institutional review boards with information to facilitate the inclusion of adolescent patients (for purposes of this guidance, defined as ages 12 to 17) in relevant adult oncology clinical trials. FDA recommends the inclusion of adolescent patients in disease- and target-appropriate adult 2
oncology clinical trials to enable earlier access to investigational and approved drugs for adolescent patients with cancer. Topics that are discussed in this guidance include the following: • Appropriate criteria for the inclusion of adolescent patients in adult oncology clinical trials at various stages of drug development • Dosing and pharmacokinetic and pharmacodynamic evaluations • Safety monitoring • Ethical considerations The information in this guidance is meant to serve as a general guideline for sponsors considering this approach. Because specific details of an adult oncology drug development program that includes adolescent patients will vary depending on the characteristics and development stage of the drug and disease(s) under evaluation, sponsors are encouraged to 1
This guidance has been prepared by the Divisions of Hematology and Oncology Products and Clinical Pharmacology V in the Center for Drug Evaluation and Research and the Oncology Center of Excellence (OCE) in cooperation with the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration. 2
For purposes of this guidance, references to drugs includes drugs and biological products approved under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) and biological products licensed under section 351 of the Public Health Service Act (42 U.S.C. 262) that are drugs.
网盘链接
百度网盘：https://pan.baidu.com/s/1vSPxr8xIOjkIMNlwkrni6A
提取码：2k9b
【温馨提示】大资料ISO是提供信息发布的专业信息类网站，所有内容均由用户发布，不代表本站观点，本站亦不存储所涉及的文件及资料。如有【免费资料】以及【付费资料】,请用户根据自己的需求，自行判断是否需要获取。如有交易诈骗、内容侵权可发送邮件至kf@dzl100.com，我们审查后若发现情况属实，会立即对相关内容进行删除处理。
加载用时：70.2224 毫秒
相关评论
相关文章
-
FDA Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials
Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials[附网盘链接]是Food And Drug Administration于不久之前发布的FDA标准，适用于US。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
-
FDA Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers
Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers[附网盘链接]是Food&Drug Administration于不久前发布的FDA标准，适用于U.S。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
-
FDA Exculpatory Language in Informed Consent
Exculpatory Language in Informed Consent[附网盘链接]是FDA于不久前发布的FDA标准，适用于美国。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
-
FDA Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products
Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products[附网盘链接]是Food And Drug Administration于不久之前发布的FDA标准，适用于US。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
-
FDA Adverse Accreditation Decisions, SuspensionRevocation of Certificates, or Patient and Physician Notification Orders Draft
Adverse Accreditation Decisions, SuspensionRevocation of Certificates, or Patient and Physician Notification Orders Draft[附网盘链接]是Food And Drug Administration于不久之前发布的FDA标准，适用于United States。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
-
![CVM GFI #185 (VICH GL43) Target Animal Safety for Veterinary Pharmaceutical Products.pdf[网盘链接]](/img/small/20210914103659dm8zg.jpg)
CVM GFI #185 (VICH GL43) Target Animal Safety for Veterinary Pharmaceutical Products.pdf[网盘链接]
GFI #185 (VICH GL43) Target Animal Safety for Veterinary Pharmaceutical Products.pdf是于发布的标准，适用于。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
-
FDA Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances
Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances[附网盘链接]是FDA于过去发布的FDA标准，适用于美国。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
-
FDA Assay Migration Studies for In Vitro Diagnostic Devices Guidance for Industry and FDA Staff
Assay Migration Studies for In Vitro Diagnostic Devices Guidance for Industry and FDA Staff[附网盘链接]是FDA于过去发布的FDA标准，适用于United States。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
-
FDA Adaptive Design Clinical Trials for Drugs and Biologics Guidance for Industry
Adaptive Design Clinical Trials for Drugs and Biologics Guidance for Industry[附网盘链接]是FDA于过去发布的FDA标准，适用于美国。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
-
FDA Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products — Content and Format
Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products — Content and Format[附网盘链接]是Food And Drug Administration于当前发布的FDA标准，适用于United States。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
-
FDA Chronic Hepatitis D Virus Infection Developing Drugs for Treatment Guidance for Industry
Chronic Hepatitis D Virus Infection Developing Drugs for Treatment Guidance for Industry[附网盘链接]是Food&Drug Administration于当前发布的FDA标准，适用于United States。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
-
FDA Converting Units of Measure for Folate, Niacin, and Vitamins A, D, and E on the Nutrition and Supplement Facts Labels
Converting Units of Measure for Folate, Niacin, and Vitamins A, D, and E on the Nutrition and Supplement Facts Labels[附网盘链接]是Food And Drug Administration于不久前发布的FDA标准，适用于US。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
-
FDA Coronary Drug-Eluting Stents — Nonclinical and Clinical Studies -Companion Document
Coronary Drug-Eluting Stents — Nonclinical and Clinical Studies -Companion Document[附网盘链接]是FDA于当前发布的FDA标准，适用于美国。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
-
FDA Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency
Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency[附网盘链接]是Food And Drug Administration于当前发布的FDA标准，适用于United States。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
-
FDA Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c)
Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c)[附网盘链接]是FDA于不久前发布的FDA标准，适用于U.S。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。