Roy van Brummelen BPharm MSc PhD DTech Institute for Pharmaceutical Services amp Van Brummelen Consultants royvbcgmailcom Method Development amp Validation Specificity Linearity and range standard amp sample ID: 1035732
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1. Analytical method development for Complementary MedicineRoy van BrummelenBPharm, MSc, PhD, DTechInstitute for Pharmaceutical Services&Van Brummelen Consultantsroyvbc@gmail.com
2. Method Development & ValidationSpecificityLinearity and range (standard & sample)AccuracySystem suitabilityPrecision Repeatability (co-validation)Limit of detectionLimit of quantificationStability of solutionsRobustness
3. Complementary MedicineMedicine is Medicine(Normal testing guideline)Complexity of Complementary MedicineDiversity in typeDiversity in approachComplexity in combinationsAvailability of methods
4. Available MethodsPharmacopoeia (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 ingredientsIngredients – clinically activeIngredients – for which methods are availableIngredients – 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? InteractionsStability intervals and conditionsWhat is possible and what not…
7. Thank you!Roy van BrummelenBPharm, MSc, PhD, DTech0825529450Institute for Pharmaceutical Services&Van Brummelen Consultantsroyvbc@gmail.com