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Bioequivalence Assessment of three 0.025% tretinoin gel products: Dermatopharmacokinetic vs. Clinical Trial Methods

Bioequivalence Assessment of three 0.025% tretinoin gel products: Dermatopharmacokinetic vs. Clinical Trial Methods. Lynn K. Pershing, Ph.D. Department of Dermatology University of Utah Salt Lake City, UT 84132. Common Goal Best Therapeutic Products. Physicians. FDA. Generic Industry.

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Bioequivalence Assessment of three 0.025% tretinoin gel products: Dermatopharmacokinetic vs. Clinical Trial Methods

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  1. Bioequivalence Assessment of three 0.025% tretinoin gel products:Dermatopharmacokinetic vs. Clinical Trial Methods Lynn K. Pershing, Ph.D. Department of Dermatology University of Utah Salt Lake City, UT 84132

  2. Common GoalBest Therapeutic Products Physicians FDA Generic Industry Innovator Industry Consumer Scientists Health Care Insurance CROs

  3. Hypothesis The dermatopharmacokinetic (DPK) method will assess the BIOEQUIVALENCE of three 0.025% tretinoin gel products similar to the Clinical Efficacy/Safety Trial method

  4. Bioequivalence How much differentcan two topical products be and still be bioequivalent?

  5. BioequivalenceQ1 Q2 similar Q1 Q2 Qualitatively similar Quantitatively similarsame same Vehicle components [Vehicle components]

  6. Bioavailability Q1 Q2 different Q1 Q2 Qualitatively different Quantitatively differentdifferent different [active] Vehicle components different [Vehicle components]

  7. Tretinoin gel, 0.025%

  8. Bioequivalence AssessmentClinical Efficacy/Safety Acne Trial

  9. Topical Drug Delivery

  10. Adhesive disc

  11. SC Drug DispositionInfluence Of Weight Removed On Drug Concentration Gradient

  12. Bioanalytical Assay Validation Tretinoin Isotretinoin • Recovery >89.7% >87.0% • Interferences None None • Linear regression 0.9963 0.9961 • Accuracy >87% >85% • Precision < 8% <11% • Assay parameters • Calibration stds 4-100 ng/mL 4-100 ng/mL • LOQ 4 ng/mL 4 ng/mL • Stability • Pre-extraction • -70oC storage 4 week 4 week • Benchtop 2 hrs 2 hrs • Post-extraction • Autosampler 112 hrs 112 hrs • Freeze thaw 1 cycle 1 cycle

  13. Product Dosing: 0.025% Tretinoin Gel 250 mcL syringe

  14. DPK Experimental Design UPTAKE ELIMINATION

  15. Product Application Randomizationtretinoin gel, 0.025%

  16. BE Study Demographics

  17. Surface Area Considerations Treated Skin Site vs. Adhesive Disc

  18. DPK Bioequivalencetretinoin gel, 0.025%

  19. DPK BioequivalenceTretinoin

  20. DPK Bioequivalencetretinoin gel, 0.025%

  21. DPK BioequivalenceIsotretinoin

  22. DPK Bioequivalencetretinoin gel, 0.025%

  23. DPK BioequivalenceTotal Retinoids

  24. Bioequivalence Assessment of Three 0.025% tretinoin gel products

  25. DPK Method for Bioequivalence Assessment • Objective • Sensitive • Discriminating • Precise • Accurate • Relevant • Scientifically • Clinically • Comparable PK method used for oral solid dosage products

  26. CONCLUSIONSDPK Method for Bioequivalence Assessment 0.025% tretinoin gel • DPK results predict Clinical Efficacy Results • DPK provides mechanistic basis for Safety Results • DPK is sensitive, reproducible and valid method for BE assessment

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