【资料】FDA:Guidance for Industry: Gingivitis: Development and Evaluation of Drugs for Treatment or
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Contains Nonbinding Recommendations
Draft – Not for Implementation
J:\!Guidanc\5146dft.doc
6/24/2005
TABLE OF CONTENTS
I. INTRODUCTION.....................................................................................................................................1
II. BACKGROUND........................................................................................................................................2
A. DEFINITION OF GINGIVITIS.................................................................................... 2
B. ANTIGINGIVITIS RULEMAKING.............................................................................. 2
III. GENERAL CONSIDERATIONS............................................................................................................3
A. PRESCRIPTION VS. OVER-THE-COUNTER STATUS OF THE DRUG ........................ 3
B. PREVENTION VS. TREATMENT CLAIM ................................................................... 3
C. MECHANISM OF ACTION ........................................................................................ 4
D. DOSE-RESPONSE RELATIONSHIP........................................................................... 4
E. COMBINATION PRODUCTS...................................................................................... 4
F. ETHICAL CONSIDERATIONS OF CONDUCTING A GINGIVITIS TRIAL .................... 4
IV. NONCLINICAL CONSIDERATIONS ..................................................................................................5
V. CLINICAL PROTOCOL ISSUES AND ELEMENTS ........................................................................9
A. STUDY DESIGN ........................................................................................................ 9
B. RANDOMIZATION.................................................................................................... 9
C. BLINDING.............................................................................................................. 10
D. LENGTH OF TRIAL ................................................................................................ 10
E. STANDARD OF CARE............................................................................................. 10
F. PLACEBO OR ACTIVE CONTROL FORMULATION ................................................ 11
G. USE OF A NO-TREATMENT GROUP....................................................................... 11
VI. CONSIDERATIONS FOR SUBJECT RECRUITMENT.................................................................11
A. SAMPLE SIZE ........................................................................................................ 11
B. INCLUSION AND EXCLUSION CRITERIA ............................................................... 11
C. SPECIAL POPULATIONS ........................................................................................ 14
D. PEDIATRIC POPULATIONS .................................................................................... 14
E. GERIATRIC POPULATIONS ................................................................................... 14
VII. ASSESSMENT OF GINGIVITIS..........................................................................................................15
A. CALIBRATING INVESTIGATOR SKILLS ................................................................. 15
B. GINGIVAL INDEX .................................................................................................. 15
C. PLAQUE INDEX...................................................................................................... 16
D. BLEEDING ON PROBING........................................................................................ 16
E. CALCULUS FORMATION ....................................................................................... 17
F. STAINING INDEX ................................................................................................... 17
G. MICROBIOLOGIC SAMPLING................................................................................ 17
VIII. CLINICAL AND STATISTICAL SIGNIFICANCE FOR DETERMINING AN EFFECT.......17
A. CLINICAL SIGNIFICANCE...................................................................................... 17
B. STATISTICAL CONSIDERATIONS........................................................................... 18
J:\!Guidanc\5146dft.doc
6/24/2005
IX. SAFETY CONSIDERATIONS..............................................................................................................19
X. CONCLUDING COMMENTS ..............................................................................................................20
Draft – Not for Implementation
J:\!Guidanc\5146dft.doc
6/24/2005
TABLE OF CONTENTS
I. INTRODUCTION.....................................................................................................................................1
II. BACKGROUND........................................................................................................................................2
A. DEFINITION OF GINGIVITIS.................................................................................... 2
B. ANTIGINGIVITIS RULEMAKING.............................................................................. 2
III. GENERAL CONSIDERATIONS............................................................................................................3
A. PRESCRIPTION VS. OVER-THE-COUNTER STATUS OF THE DRUG ........................ 3
B. PREVENTION VS. TREATMENT CLAIM ................................................................... 3
C. MECHANISM OF ACTION ........................................................................................ 4
D. DOSE-RESPONSE RELATIONSHIP........................................................................... 4
E. COMBINATION PRODUCTS...................................................................................... 4
F. ETHICAL CONSIDERATIONS OF CONDUCTING A GINGIVITIS TRIAL .................... 4
IV. NONCLINICAL CONSIDERATIONS ..................................................................................................5
V. CLINICAL PROTOCOL ISSUES AND ELEMENTS ........................................................................9
A. STUDY DESIGN ........................................................................................................ 9
B. RANDOMIZATION.................................................................................................... 9
C. BLINDING.............................................................................................................. 10
D. LENGTH OF TRIAL ................................................................................................ 10
E. STANDARD OF CARE............................................................................................. 10
F. PLACEBO OR ACTIVE CONTROL FORMULATION ................................................ 11
G. USE OF A NO-TREATMENT GROUP....................................................................... 11
VI. CONSIDERATIONS FOR SUBJECT RECRUITMENT.................................................................11
A. SAMPLE SIZE ........................................................................................................ 11
B. INCLUSION AND EXCLUSION CRITERIA ............................................................... 11
C. SPECIAL POPULATIONS ........................................................................................ 14
D. PEDIATRIC POPULATIONS .................................................................................... 14
E. GERIATRIC POPULATIONS ................................................................................... 14
VII. ASSESSMENT OF GINGIVITIS..........................................................................................................15
A. CALIBRATING INVESTIGATOR SKILLS ................................................................. 15
B. GINGIVAL INDEX .................................................................................................. 15
C. PLAQUE INDEX...................................................................................................... 16
D. BLEEDING ON PROBING........................................................................................ 16
E. CALCULUS FORMATION ....................................................................................... 17
F. STAINING INDEX ................................................................................................... 17
G. MICROBIOLOGIC SAMPLING................................................................................ 17
VIII. CLINICAL AND STATISTICAL SIGNIFICANCE FOR DETERMINING AN EFFECT.......17
A. CLINICAL SIGNIFICANCE...................................................................................... 17
B. STATISTICAL CONSIDERATIONS........................................................................... 18
J:\!Guidanc\5146dft.doc
6/24/2005
IX. SAFETY CONSIDERATIONS..............................................................................................................19
X. CONCLUDING COMMENTS ..............................................................................................................20
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