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Clinical Trial Protocol for Antibacterial Drug

Clinical Trial Protocol for Antibacterial Drug

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Published by Gunja Chaturvedi

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Categories:Types, Research, Science
Published by: Gunja Chaturvedi on Oct 29, 2009
Copyright:Attribution Non-commercial

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01/01/2013

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ASSIGNMENT NO: 01
TO GIVE AN OVER VIEW AND PROTOCOL FORTHE CONDUCT OF CLINICAL TRIAL FOR AN ANTI BACTERIAL DRUG(MODEL DRUG)
SUBMITTED TO
Prof. Gautam SinghviInstructor-in-charge
SUBMITTED BY:Sr.NO.NAME ID NO.1.
Gunja Chaturvedi 2008H146101
2.
R.Vidya 2008H146102
Submitted for the partial fulfillment of the requirements of thecourse
CLINICAL RESEARCH (PHA G543)BIRLA INSTITUTE OF TECHNOLOGY AND SCIENCEPILANI (RAJASTHAN)AUGUST, 2009
 
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INDEX
A.
 
Study detailsB.
 
Introduction & Objectives
1.
 
Background2.
 
Introduction3.
 
Preclinical data for the Model drug4.
 
Mechanism of action5.
 
Bioequivalence requirement6.
 
Pharmacology6.1.1
 
Absorption6.1.2
 
Distribution6.1.3
 
Metabolism6.1.4
 
Excretion6.1.5
 
Adverse drug events6.1.6
 
Dosage7.
 
Study design7.1.1
 
Summary7.1.2
 
No. of subjects planned7.1.3
 
No. of subjects enrolled7.1.4
 
No. of subjects included in primary analysis & safety datasheet7.1.5
 
Gender7.1.6
 
Mean (SD) of age7.1.7
 
Diagnosis and main criteria for eligibility7.1.8
 
Investigational product, dose and mode of administration7.1.9
 
Washout periods
 
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 7.1.10
 
Duration of treatment8.
 
Restrictions8.1.1
 
Medications8.1.2
 
Diet8.1.3
 
Activity9.
 
Study population9.1.1
 
Screening assessments (lab tests and general examinations)9.1.2
 
Inclusion criteria9.1.3
 
Exclusion criteria10.
 
Study endpoints10.1.1
 
Primary endpoints10.1.2
 
Secondary endpoints11.
 
Schedule of assessment12.
 
Study medication12.1.1
 
Handling, storage & accountability procedure12.1.2
 
Return or Destruction of Study Drug13.
 
Analytical procedures , Pharmacokinetic studies and assessment of patient compliance13.1.1
 
Microbiological assessment13.1.2
 
Pharmacokinetic Characteristics13.1.3
 
Assessment of compliance14.
 
Safety:14.1.1
 
Clinical safety measurement15.
 
Handling of safety parameters15.1.1
 
Adverse drug events management15.1.2
 
Reporting of Serious Adverse Events

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