Bioavailability, Bioequivalence & Bioethics

The concept of BE has been accepted worldwide by the pharmaceutical industry and national regulatory authorities for over 20 years and is applied to new as well as generic products. As a result, thousands of high-quality generic drugs at reduced costs have become available in every corner of the globe. The assessment of BE is not a simple issue, however, and much of the research has been done in recent years to develop new and more effective approaches to the assessment of BE.

Since then, and after turn of the century, tremendous advancements have been made by the FDA and other regulatory authorities (national, international, and supranational), and by industry and academia in the area of assessment of bioequivalence. Currently approaches to determine BE of pharmaceutical products has been largely standardized. This has occurred due to discussion and consensus reached among various stakeholders at numerous national and international meetings, conferences, and workshops.

The pharmaceutical firms all over the world are burning the candle at both ends for attainment of market authorizations in various nations.

Bioethics can evaluate global justice by weighing human rights theory and future innovation at the macro level, and by addressing market forces and responsibilities at the micro level. Inherent structural features of pharmaceuticals, such as its reliance on research and development, cause the industry to employ pricing strategies that seem counter-intuitive to conventional wisdom, but that result in producing a just allocation as defined by market forces.

  • Scope of Guidelines
  • Pharmacokinetic and Pharmacodynamic Studies
  • In-Vitri and In Vivo Studoies
  • Bioethical challenges of new technology

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