FDA #178 Recommended Design and Evaluation of Effectiveness Studies for Swine Respiratory Disease Claims

标准简介

#178 Recommended Design and Evaluation of Effectiveness Studies for Swine Respiratory Disease Claims[附网盘链接]是FDA于当前发布的FDA标准,适用于U.S。

标准截图

#178 Recommended Design and Evaluation of Effectiveness Studies for Swine Respiratory Disease Claims[附网盘链接]
#178 Recommended Design and Evaluation of Effectiveness Studies for Swine Respiratory Disease Claims[附网盘链接](截图)

 

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标准文档类型为#178 Recommended Design and Evaluation of Effectiveness Studies for Swine Respiratory Disease Claims[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

TABLE OF CONTENTS INTRODUCTION Page 3 SECTION 1: RECOMMENDED STUDY DESIGN AND EVALUATION OF EFFECTIVENESS STUDIES FOR SRD 1. Recommended Study Design Page 5 2. Selection of Study Animals Page 9 3. Inclusion/Exclusion Criteria Page 9 4. Post-inclusion Removal of Sites, Pens, or Pigs from the Study Page 10 5. Assessment of Effectiveness Page 12 6. Statistical Methods Page 14 SECTION 2: RECOMMENDED STUDY DESIGN AND EVALUATION OF EFFECTIVENESS STUDIES FOR SRD ASSOCIATED WITH MYCOPLASMA HYOPNEUMONIAE 1. Model Study Considerations Page 15

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