Analytical methods validation: bioavailability, bioequivalence and pharmacokinetic studies. Conference report

Area of Science:

• Pharmaceutical Sciences
• Analytical Chemistry
• Pharmacokinetics

Background:

• Summary report of a 1990 conference on Analytical Methods Validation.
• Focused on bioavailability, bioequivalence, and pharmacokinetic studies.
• Sponsored by major pharmaceutical and regulatory organizations.

Framework:

• Establish consensus on analytical methods validation requirements and procedures.
• Determine processes for applying validation in bioavailability, bioequivalence, and pharmacokinetic studies.
• Develop guiding principles for future formal guidelines.

Implementation:

• Discussed acceptable standards for documenting and validating analytical methods.
• Considered processes, parameters, and data treatments for pharmacokinetic assessments.
• Addressed measurement of drug metabolites and stereoselective determinations.

Implications:

• Provide guiding principles for validating analytical methods in human and animal studies.
• Facilitate consistent and reliable drug development and regulatory submissions.
• Inform future formal guidelines for analytical methods validation.