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Biopharmaceutics and BCS: Future Role in Discovery, Development, and Regulation, as Presented by Dr. Gordon Amidon

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Lecture #31 from the Drug Delivery Foundation's 2010 Oral Drug Delivery Conference: http://www.ddfint.org/previous-events/2017/4/22/odd2010-strategies-for-oral-drug-delivery

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Biopharmaceutics and BCS: Future Role in Discovery, Development, and Regulation, as Presented by Dr. Gordon Amidon

  1. 1. Gordon L Amidon College of Pharmacy University of Michigan Ann Arbor, MI 48109
  2. 2.  GI Physiology: Transport Mechanistic  Permeability &Transit  Physical Chemistry: InVivo Dissolution  Solubility/Dissolution  Biopharmaceutical Evaluation: Mechanistic  InVivo-InVitro  Dosage FormTechnology: Optimization of Delivery  IR and MR  Regulatory Advances: Separate BE and BA Science  Essential Standard to Insure Label Claims
  3. 3. Efficacy Safety Half life Bioavailability Dose is actually a surrogate of BA
  4. 4. 1970’s Descriptive / Empirical 1980’s Mechanistic/ Organ 1990’s Tissue/ Cell 2000’s Genomic/ Membrane 1960 Biopharmaceutics: The Beginning
  5. 5. ∫∫∫ ⋅∞= t A effabs CdAdtPMtMF 0 )(/)(
  6. 6. Unknown localization: HPT1, CAT-1, EAAC1, CNT, CNT2, ENT1, ENT2, SAAT1, NBC2, NPT4, NAPI-3B, SVCT1-2, FAT Fig. A. Localization of intestinal membrane transporters and their coupling for nutrients and drug absorption. Arrows indicate the direction of transport. Dashed arrows indicate the coupling of apical transporters with basolateral transporters. rBAT and b0,+AT form a complex for functional transporter. HLAT and 4F2hc, hy+ LAT and 4F2hc also form a transporter complex. Apical membraneIntestinal lumen Basal membrane rBAT 4F2hc ATB0 TAUT b0,+AT hPepT1 MCT1 MOAT MDR IBAT FATP4 SGLT1 GLUT5 GLUT2 OCT1 OCT3 ILBP HLAT ? hy+ LAT ? ? ? ? ?
  7. 7. Label Product Efficacy & “BE”
  8. 8. August 2000 FDA Guidance Amidon et al.., Pharmaceutical Research, 12, 413 (1995).
  9. 9. Biopharmaceutics History: What Happened 1960 : Limited Technology 1990: A BA View 2010: Molecular Mechanism
  10. 10.  Mechanistic  GI Physiology and Product Dissolution  Focused on Product: BE and labeling  Dissolution Methodology and BCS InVivo Relevance  Mechanistic ADME: BCS and BDDCS

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