FDA Allergic Rhinitis Developing Drug Products for Treatment Guidance for Industry
标准简介
Allergic Rhinitis Developing Drug Products for Treatment Guidance for Industry[附网盘链接]由FDA于过去发布，适用于US。标准截图
![Allergic Rhinitis Developing Drug Products for Treatment Guidance for Industry[附网盘链接]](/img/202109141035501r1fy.jpg)
标准文档说明
标准文档类型为Allergic Rhinitis Developing Drug Products for Treatment Guidance for Industry[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
Allergic Rhinitis: Developing Drug Products for Treatment 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 office responsible for this guidance as listed on the title page. I. INTRODUCTION The purpose of this guidance is to assist sponsors in the development of drug products for the 2
treatment of allergic rhinitis in children and adults. The guidance addresses issues of trial design, effectiveness, and safety for new products being developed for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR). The recommendations in this guidance are based on an assessment of important issues raised in the review of both adult and pediatric allergic rhinitis clinical trials and the Agency’s current understanding of the mechanism of the two related disorders of SAR and PAR. The pathophysiology of SAR and PAR are similar in terms of the chemical mediators produced and end-organ manifestations, with differences between the two entities primarily based on the causes and duration of disease. The trial design issues pertaining to SAR and PAR trials are also similar. Thus, these two categories are treated collectively in this guidance as allergic rhinitis, with differences in recommendations for the design of SAR and PAR trials indicated. Sponsors are encouraged to discuss details of trial design and specific issues relating to individual products with division review staff before conducting clinical trials. This guidance does not contain discussion of the general issues of statistical analysis or clinical trial design. Those topics are addressed in the ICH guidances for industry E9 Statistical Principles for Clinical Trials and E10 Choice of Control Group and Related Issues in Clinical 1
This guidance has been prepared by the Division of Pulmonary, Allergy, and Rheumatology Products in the Center for Drug Evaluation and Research at the Food and Drug Administration. 2
For the purposes of this guidance, the term drug product is inclusive of the small or large molecule active moiety or moieties in the formulation, along with the delivery device, if applicable. 1
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