CVM GFI #185 (VICH GL43) Target Animal Safety for Veterinary Pharmaceutical Products.pdf[网盘链接]

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VICH GL 43 (TARGET ANIMAL SAFETY) - PHARMACEUTICALS July 2008 For implementation at Step 7 TARGET ANIMAL SAFETY FOR VETERINARY PHARMACEUTICAL PRODUCTS Adopted at Step 7 of the VICH Process by the VICH Steering Committee in July 2008 for implementation in July 2009 THIS GUIDELINE HAS BEEN DEVELOPED BY THE APPROPRIATE VICH EXPERT WORKING GROUP AND HAS BEEN SUBJECT TO CONSULTATION BY THE PARTIES, IN ACCORDANCE WITH THE VICH PROCESS. AT STEP 7 OF THE PROCESS THE FINAL DRAFT IS RECOMMENDED FOR ADOPTION TO THE REGULATORY BODIES OF THE EUROPEAN UNION, JAPAN , AND USA. Contains Non-Binding Recommendations 

TABLE OF CONTENTS 

1. INTRODUCTION .4 

1.1 OBJECTIVE.4 

1.2 BACKGROUND..4 

1.3 SCOPE ..5 

2. MARGIN OF SAFETY STUDIES ..5 

2.1 STANDARDS ..6 

2.2 ANIMALS 6 

2.3 ROUTE OF ADMINISTRATION.7 

2.4 DOSE, FREQUENCY, AND DURATION OF ADMINISTRATION 7 

2.5 STUDY DESIGN 8 

2.6 VARIABLES 9 

2.6.1 PHYSICAL EXAMINATIONS AND OBSERVATIONS.9 

2.6.2 CLINICAL PATHOLOGY TESTS (HEMATOLOGY, BLOOD CHEMISTRY, URINALYSIS) 10 

2.6.3 NECROPSY AND HISTOPATHOLOGY EXAMINATIONS..11 

2.7 STATISTICAL ANALYSIS12 

2.8 STUDY REPORTS ..14 

3. OTHER LABORATORY SAFETY STUDY DESIGNS.14 

3.1 INJECTION SITE SAFETY STUDIES.14 

3.2 ADMINISTRATION SITE SAFETY STUDIES FOR DERMALLY APPLIED TOPICAL PRODUCT..14 

3.3 REPRODUCTIVE SAFETY STUDIES 15 

3.4 MAMMARY GLAND SAFETY STUDIES 16 

4. TARGET ANIMAL SAFETY DATA FROM FIELD STUDIES..17 

5. RISK ASSESSMENT IN ANIMAL SAFETY EVALUATION..17 

6. GLOSSARY 18 

Page 3 of 19 

Contains Non-Binding Recommendations 

This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. 

1. INTRODUCTION 

1 Data from target animal safety (TAS) studies are required for registration of veterinary products in the regions participating in the VICH. International harmonization of standards for essential TAS studies will facilitate adequacy of data and minimize the need to perform separate studies for regulatory authorities of different countries. Appropriate international standards should reduce research and development costs by minimizing repetition of similar studies in each region. Animal welfare should benefit because fewer animals may be needed. This VICH TAS guidance has been developed as a harmonized standard to aid in development of mutually acceptable TAS studies for relevant governmental regulatory bodies. The use of this VICH guidance to support registration of a product for local distribution only is strongly encouraged but is up to the discretion of the local regulatory authority. FDA’s guidance documents, including this guidance, 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. 

1.1 Objective The purpose of this harmonized guidance is to provide recommendations regarding TAS evaluation for regulatory submission of an Investigational Veterinary Pharmaceutical Product (IVPP), which is appropriate for determining the safety of an IVPP in the target animal, including identification of target organs, where possible, and confirmation of margin of safety, using the minimum number of animals appropriate for the studies. 

1.2 Background The VICH was initiated to develop internationally harmonized guidance that outlines recommendations for meeting regulatory requirements for registration of an IVPP in the regions 1 See 21 U.S.C. § 360b(b)(1); 21 U.S.C. § 360b(d)(1)(A); 21 CFR 514.1(b)(8). Page 4 of 19

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