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Clinical Study Report: Bioequivalence, General concepts and overview

Objective. To assist sponsors in the development of areport that is complete, free from ambiguity,well organized, and easy to reviewa clear explanation of how the critical design features of the study were chosenanalytical methods full description of safety, all individual subject data (PK

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Clinical Study Report: Bioequivalence, General concepts and overview

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    1. Clinical Study Report: Bioequivalence, General concepts and overview Ariya Khunvichai, Ph.D. 20 April 2007

    2. Objective To assist sponsors in the development of a report that is complete, free from ambiguity, well organized, and easy to review a clear explanation of how the critical design features of the study were chosen analytical methods full description of safety, all individual subject data (PK ,adverse events or laboratory abnormalities, demographic information) data listings (usually in Appendix)

    3. General Information Data should be presented in the report at different levels - Most important data (fig, tab) should be placed in the text to illustrate important points; others should be provided in section 14 or 16. In any table, figure or data listing, detailed explanations should be provided

    4. Title Page Synopsis Table of Contents List of Abbreviation Ethics Investigators and Study Administrative Structure Introduction Study Objectives (from protocol) Investigation Plan (from protocol) Study Patients Pharmacokinetic Evaluation Safety Evaluation Discussion and Overall Conclusions Tables, Figures, referred to but not included in the text References Appendices Summary Basis of Clinical Study Report

    5. Study title Protocol identification (code or number) Test drug Indication Development phase Study start date (ICH—“first subject enrolled, or other verifiable definition”) Study end date (date last subject completed follow-up) Principal Investigator (Name and affiliation of principal or coordinating investigator, or sponsor’s responsible medical officer.) Sponsor Compliance statement (This study was conducted in full compliance with the guidelines of Good Clinical Practice and of the World Medical Assembly Declaration of Helsinki) Date of report

    8. The page number or other locating information of each section, including summary tables, figures and graphs A list and the locations of appendices, tabulations, and any case report forms provided

    9. Ethics committee or Institutional Review Board The study protocol, informed consent, and other necessary documents were reviewed and approved by an Ethics Committee (EC) or Institutional Review Board (IRB) for each study site prior to initiation of the study at that site. A list of the EC/IRBs that reviewed these documents for the clinical stud sites is given in Appendix 16 Ethical Conduct of the Study This study was conducted in accordance with Good Clinical Practice (GCP) as described in International Conference on Harmonization (ICH) Guideline E6, Good Clinical Practice. The ICH GCP guideline is consistent with the World Medical Assembly Declaration of Helsinki.

    47. The Last Step!!! All Clinical study reports must be approved by the PI , and sponsors (PK, BA,) The report should be approved (signed and dated) by the responsible persons

    48. Thank you and Discussions!

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