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World Health Organization : Year 1999 ; Communicable Diseases and Emerging Infectious Diseases ; Tuberculosis, No. 99.274: Establishing the Bioequivalence of Rifampicin in Fixed Dose Formulations Containing Isoniazid with or Without Pyrazinamide Andlor Ethambutol Compared to the Single Drug Reference Preparations Administered in Loose Combination

By World Health Organization

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Book Id: WPLBN0000118114
Format Type: PDF eBook
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Reproduction Date: 2005
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Title: World Health Organization : Year 1999 ; Communicable Diseases and Emerging Infectious Diseases ; Tuberculosis, No. 99.274: Establishing the Bioequivalence of Rifampicin in Fixed Dose Formulations Containing Isoniazid with or Without Pyrazinamide Andlor Ethambutol Compared to the Single Drug Reference Preparations Administered in Loose Combination  
Author: World Health Organization
Volume:
Language: English
Subject: Health., Public health, Wellness programs
Collections: Medical Library Collection, World Health Collection
Historic
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Publisher: World Health Organization

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Organization, W. H. (n.d.). World Health Organization : Year 1999 ; Communicable Diseases and Emerging Infectious Diseases ; Tuberculosis, No. 99.274. Retrieved from http://worldebooklibrary.com/


Description
Medical Reference Publication

Excerpt
IMPORTANT This protocol is intended to serve as a guideline for the determination ofbioavailability of only the rifampicin component in a fixed dose combination (FDC) anti-tuberculosis preparation. It is done by a restriction of the number of assay-points up to 8 hours only, which is different to the number of points which would be used if companion drugs in the preparation (such as pyrazinamide or ethambutol) were to be studied also (0-48 hours). This protocol would, however, also be applicable for estimating isoniazid bioavailability. In all other respects, the procedures are identical to those utilising the usual extended series of time-points. The restriction of time-points does not affect the accuracy of therifampicin bioavailability estimate (see reference Mcllleron et al., p12). It does, however, represent considerable savings in time and cost.

Table of Contents
TABLE OF CONTENTS CONTACT DETAILS .......................................................................................................................................... 7 INVESTIGATOR SIGNATURE PAGE .............................................................................................................. 8 RESPONSIBILITY. ................................................................................................................................................. 8 NAMEA ND QUALIFICATION ................................................................................................................................. 8 ADDRES.S.. .......................................................................................................................................................... 8 SIGNATURAEN D DATE ........................................................................................................................................ 8 LIST OF STUDY MEDICATIONS ..................................................................................................................... 9 INTRODUCTION ............................................................................................................................................... 10 RATIONALE AND PURPOSE OF THE STUDY ....................................................................................................... 1 0 OBJECTIV.E... .................................................................................................................................................... 10 METHODS .......................................................................................................................................................... 11 STUDYSI TES ..................................................................................................................................................... 11 STUDYD ESIGN ............................................................................................................................................. 1 RANDOMISATION .............................................................................................................................................. 1 SAMPLSEI ZE ..................................................................................................................................................... 11 RECRUITMENOTF STUDY SUBJECTS .................................................................................................................. 1 2 INCLUSION CRITERIA ........................................................................................................................................ 12 EXCLUSIOCNR ITERIA. ...................................................................................................................................... 1 2 STUDYS UBJECT WITHDRAWAL .......................................................................................................................... 12 PEN-STUDYRE STRICTIONS ............................................................................................................................... 1 3 INFORMED WRITTEN CONSENT ........................................................................................................................... 13 HIV-TESTING... ................................................................................................................................................. 13 ADVERSEE VENTS ............................................................................................................................................. 13 SELECTIOONF REFERENCE PREPARATIONS. ........................................................................................................ 14 SUPPLY, LABELLING AND PACKAGING OF DRUGS ...............................................................................

 

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