Workshop on BCS Drug Evaluation and Bioequivalence


Program Goal

This course will offer a scientific program focused in BCS application. Lectures and hands on BCS, methods for estimating and evaluating drug intestinal absorption, dissolution test and IVIVC. Full program is available here.

Location: La Habana, Cuba, September 2016

Organizing Committee

  • Miguel Angel Cabrera Perez
  • Isabel Gonzalez-Alvarez
  • Marival Bermejo
  • Gordon L. Amidon

Speakers

  • Gordon L. Amidon, Professor, University of Michigan, United States
  • Marival Bermejo, Professor, Miguel Hernandez University, Spain
  • Miguel Angel Cabrera, Professor. Universidad de Las Villas, Santa Clara, Cuba
  • Arik Dahan, Assoc. Professor, Ben-Gurion University, Israel
  • Isabel González-Álvarez, Assoc Professor, Miguel Hernandez University, Spain
  • Peter Langguth, Professor, University of Mainz, TBC
  • Salomon Stavchansky, Professor, University of Texas, TBC

Sponsors

  • Center of Genetic Engineering and Biotechnology
  • Cuban Society of Pharmacology
  • Drug Delivery Foundation

Agenda

DAY 1 Session I: BCS concepts

  • 09:00-09:15: OPENING CEREMONY
  • 09:15-10:00: Cuban Universities role in Biopharmaceutical optimization, Miguel Angel Cabrera
  • 10:00 - 10:45: Scientific bases of BCS and In vitro Bioequivalence, Gordon Amidon
  • 10:45 - 11:30: Current Regulatory BE Biowaiver Standards: FDA and EMA, Peter Langguth
  • 11:30 – 12:00: COFFEE BREAK
  • 12:00 – 12:45: Provisional BCS classification of WHO essential medicines, Marival Bermejo
  • 12:45 – 13:30: Statistical design and Evaluation of Bioequivalence Studies - Average Bioequivalence, Salomon Stavchansky
  • 13:30 – 14:15: Approaches of Therapeutic equivalence in Cuba, Celeste Sanchez
  • 14:15 – 15:00: Regulatory approaches for BE globally, Marival Bermejo

DAY 2 Session II: BCS parameters

  • 09:15-10:00: Intestinal Segmental Dependent Absorption and BE Standards, Arik Dahan
  • 10:00 - 10:45: Scientific and Regulatory Considerations of Biosimilars: A Global Perspective, Salomon Stavchansky
  • 10:45-11.30: The solubility-permeability interplay. Supersaturation and absorption, Arik Dahan
  • 11:30 – 12:00: COFFEE BREAK
  • 12:00 – 12:45: Bicarbonate Buffer, Gordon Amidon
  • 12:45 – 13:30: Challenges and Opportunities of Drug Excipient Interactions, Salomon Stavchansky
  • 13:30 – 14:15: BCS Class II Biowaivers and In Vitro—In Vivo Relationships, Peter Langguth
  • 14:15 – 15:00: Refined Classification of BCS, Gordon Amidon

DAY 3 Session III: Hands on parameters calculation

  • 09:30 -10:15: In vitro/in vivo correlation, Isabel González/Marival Bermejo
  • 10:15 - 11:00: Dimensionless number estimation and BCS classification, Gordon Amidon
  • 11:00 - 12:00: In silico methods for predicting permeability and solubility. In silico provisional BCS classification, Miguel Angel Cabrera
  • 12:00 – 12:30: COFFEE BREAK
  • 12:30 – 13:00: In vitro dissolution tests: kinetic models and profile comparisons. F2 calculation, Isabel González
  • 13:00 – 14:00: In vitro and in situ methods for permeability estimation, Isabel González

Other Notes

Attendants should have their own laptops with Microsoft Office or Open Office. Lectures will be in Spanish and English. No simultaneous translation provided.