Today, the assessment of immunogenicity is integral in nonclinical and clinical testing of new biotherapeutics and biosimilars. A key component in the risk-based evaluation of immunogenicity involves the detection and characterization of anti-drug antibodies (ADA). Over the past couple of decades, much progress has been made in standardizing the generalized approach for ADA testing with a three-tiered testing paradigm involving screening, confirmation, and quasi-quantitative titer assessment representing the typical harmonized scheme. Depending on a biotherapeutic’s structural attributes, more characterization and testing may be appropriate. Unlike bioanalytical assays used to support the evaluation of pharmacokinetics or toxicokinetics, an important component in immunogenicity testing is the calculation of cut points for the identification (screening), confirmation (specificity), and titer assessment responses in animals and humans. Several key publications have laid an excellent foundation for statistical design and data analysis to determine immunogenicity cut points. Yet, the process for statistical determination of cut points remains a topic of active discussion by investigators who conduct immunogenicity assessments to support biotherapeutic drug development. In recent years, we have refined our statistical approach to address the challenges that have arisen due to the evolution in biotherapeutics and the analytical technologies used for quasi-quantitative detection. Based on this collective experience, we offer a simplified statistical analysis process and flow-scheme for cut point evaluations that should work in a large majority of projects to provide reliable estimates for the screening, confirmatory, and titering cut points.

Viswanath Devanarayan

Wendell C. Smith

Rocco L. Brunelle

Mary E. Seger

Kim Krug

Ronald R. Bowsher

The AAPS Journal

AAPS 杂志是美国药物科学家协会 (AAPS) 的官方期刊，发表了影响人类和兽医治疗的药物科学各个领域的新颖而重要的发现，包括：· 药物设计和发现· 制药生物技术· 生物制药、制剂, 和药物递送· 代谢和运输· 药代动力学、药效学和药效学· 转化研究· 临床评估和治疗结果· 监管科学我们邀请以下文章类型提交：· 原创研究文章· 评论和小型评论· 白皮书、评论, 和社论· 会议报告· 简要/技术报告和快速通信· 监管说明· 教程· 药物科学协议此外，AAPS 期刊还发布由客座编辑组织的主题，重点关注我们领域当前感兴趣的特定领域.

AAPS Journal is the official journal of the American Association of Pharmaceutical Scientists (AAPS), publishing novel and significant findings across various fields of pharmaceutical science that impact human and veterinary therapeutics. The main topics include: drug design and discovery, pharmaceutical biotechnology, biopharmaceuticals, formulation and drug delivery, metabolism and transport, pharmacokinetics, pharmacodynamics, translational research, clinical evaluation and therapeutic outcomes, and regulatory science. We invite submissions of the following article types: original research articles, reviews and mini-reviews, white papers, commentaries and editorials, conference reports, brief/technical reports and rapid communications, regulatory guidelines, tutorials, and pharmaceutical science protocols. Additionally, AAPS Journal publishes themed issues organized by guest editors, focusing on specific areas of current interest in our field.

AAPS Journal 是美国药物科学家协会 (AAPS) 的官方期刊，发表影响人类和兽医治疗的药物科学各个领域的新颖而重要的发现。主要涵盖以下主题：药物设计与发现、制药生物技术、生物制药、制剂与药物递送、代谢与运输、药代动力学、药效学、转化研究、临床评估与治疗结果以及监管科学。我们欢迎以下类型的文章提交：原创研究文章、评论与小型评论、白皮书、评论与社论、会议报告、简要/技术报告与快速通信、监管说明、教程及药物科学协议。此外，AAPS Journal 还发布由客座编辑组织的主题，重点关注我们领域当前感兴趣的特定领域。

AAPS Journal

Recommendations for Systematic Statistical Computation of Immunogenicity Cut Points

A simplified statistical analysis process and flow-scheme for cut point evaluations that should work in a large majority of projects to provide reliable estimates for the screening, confirmatory, and titering cut points is offered.

Category	Quartile
医学	3
医学, 药学	3

Recommendations for Systematic Statistical Computation of Immunogenicity Cut Points

ivySCI AI Smartly Parses PDF, Answers Researchers' Questions, and Helps You Understand Papers in Seconds

Journal Info

Category	Quartile
PHARMACOLOGY & PHARMACY	1