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Analytical method development for Complementary Medicine

Analytical method development for Complementary Medicine. Roy van Brummelen BPharm , MSc, PhD, DTech Institute for Pharmaceutical Services & Van Brummelen Consultants royvbc@gmail.com. Method Development & Validation. Specificity Linearity and range (standard & sample) Accuracy

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Analytical method development for Complementary Medicine

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  1. Analytical method development for Complementary Medicine Roy van Brummelen BPharm, MSc, PhD, DTech Institute for Pharmaceutical Services & Van Brummelen Consultants royvbc@gmail.com

  2. Method Development & Validation • Specificity • Linearity and range (standard & sample) • Accuracy • System suitability • Precision • Repeatability (co-validation) • Limit of detection • Limit of quantification • Stability of solutions • Robustness

  3. Complementary Medicine • Medicine is Medicine (Normal testing guideline) • Complexity of Complementary Medicine • Diversity in type • Diversity in approach • Complexity in combinations • Availability of methods

  4. Available Methods • Pharmacopoeia (recognized) i.e. USP, BP, etc. • Other “Pharmacopoeia” i.e. WHO, AAMPS (with method validation) • Scientific publications (with method validation) • What to test…?

  5. Determining actives… • CoA? Standardised against…? • Steps: • All ingredients • Ingredients – clinically active • Ingredients – for which methods areavailable • Ingredients – in measurable quantities (with method validation)

  6. Other problems(situations that has to be handled correctly…) • What to test? • All actives at all times? • Overages? • Interactions • Stability intervals and conditions • What is possible and what not…

  7. Thank you! Roy van Brummelen BPharm, MSc, PhD, DTech 0825529450 Institute for Pharmaceutical Services & Van Brummelen Consultants royvbc@gmail.com

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