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43 - MDC - Medical Sciences and Clinical Research


MDC 125 - Clinical Research, Bioequivalence and Bioavailability Studies

Code Start Date Duration Venue Fees
MDC 125 29 November 2020 5 Days Istanbul $ 3450 Registration Form Link
MDC 125 27 December 2020 5 Days Istanbul $ 3450 Registration Form Link
MDC 125 10 January 2021 5 Days Istanbul $ 3450 Registration Form Link
MDC 125 07 February 2021 5 Days Istanbul $ 3450 Registration Form Link
MDC 125 07 March 2021 5 Days Istanbul $ 3450 Registration Form Link
MDC 125 04 April 2021 5 Days Istanbul $ 3450 Registration Form Link
MDC 125 02 May 2021 5 Days Istanbul $ 3450 Registration Form Link
MDC 125 27 June 2021 5 Days Istanbul $ 3450 Registration Form Link
MDC 125 25 July 2021 5 Days Istanbul $ 3450 Registration Form Link
MDC 125 22 August 2021 5 Days Istanbul $ 3450 Registration Form Link
MDC 125 19 September 2021 5 Days Istanbul $ 3450 Registration Form Link
MDC 125 17 October 2021 5 Days Istanbul $ 3450 Registration Form Link
MDC 125 14 November 2021 5 Days Istanbul $ 3450 Registration Form Link
MDC 125 12 December 2021 5 Days Istanbul $ 3450 Registration Form Link
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Course Description

Bioavailability (BA) and Bioequivalence (BE) studies are required of new as well as generic drug products. BA/BE are parameters with practical and public health value for drug manufacturers, for regulatory agencies, and ultimately for patients. From a drug product performance perspective,  this course provides a broad perspective on the theory and practice of BA/BE, After attending this course, participants should have the ability to plan, conduct, report and evaluate bioequivalence studies skillfully.

Course Objectives

  • Conveying the knowledge necessary to design and analyse bioequivalence trials
  • Enhancing the understanding of their history and place within drug development
  • Reviewing recent developments and their implications
  • Interpreting and discussing the statistics used

Who Should Attend?

  • Regulatory staff in the study design, study and conduct,
  • Health professionals involved in  pharmacokinetic analysis,
  • Health professionals involved in statistical analysis,
  • Health professionals involved in reporting and evaluation of bioequivalence studies.

Course Details/Schedule

Day 1

  • Basic pharmacokinetics principles
  • Bioavailability determinants (AUCt, AUCinf, Cmax,Tmax, etc.)
  • Design of both single and multiple dose studies
  • Mean versus individual ratio analyses

Day 2

  • Confidence interval calculations
  • Food and other factors affecting bioavailability
  • Controlled release formulations
  • Cmax – Cmin fluctuations

 

Day 3

  • Intrasubject variability
  • Drug interchangeability (“prescribability” versus “switchability”)
  • In vitro dissolution as a predictor of bioequivalence
  • Cmax/AUC and other proposed metrics for drug absorption rate

 

Day 4

  • Instances of possible use of metabolite data
  • Therapeutic equivalence
  • US & European regulatory requirements
  • Problem areas (e.g. highly variable drugs, nonlinearity)
  • “Hands-on”exercises

 

Day 5

  • Facilities for conducting BA/BE studies
  • Regulatory aspects of BE studies
  • Intellectual property rights