Bioequivalence and Bioavailability Forum

Dear all,

last year Charlie DiLiberti founded the not-profit organization SAAMnow and provided me the detailed program of the Spring 2019 Workshop

Challenging Statistical Issues with In Vitro and In Vivo Bioequivalence Studies: Extreme Variability, Special Study Designs and Novel Approaches

which will take place April 4/5 in Rockville, MD, USA.

Day 1 – Session 1: Extreme Variability and Aberrant Data in BE Studies

• Outliers and Aberrant PK Data in Bioequivalence Studies – Industry Perspective
  
• Outliers and Aberrant PK Data in Bioequivalence Studies – FDA Perspective
  
• RLDs with high lot-to-lot variability – Issues and Novel Solutions
  
• When Even Reference Scaling Is Not Enough: Bioequivalence Studies on Extremely Variable Drugs (EVDs)
  
• Baseline Correction for Endogenous Drugs – Getting it Right
  
• Panel Discussion on Extreme Variability and Aberrant Data in BE Studies

Day 1 – Session 2: In Vitro BE Statistical Issues

• Statistical Issues for Low Permeability Compounds in IVPT Studies
  
• Sample Size Calculations for IVPT Studies
  
• Statistical Issues with Aberrant IVRT/IVPT Data – FDA Perspective
  
• Equivalence Criteria for In Vitro BE Tests for Locally Acting Drug Products: The Earth Mover’s Distance Approach
  
• Panel Discussion on In Vitro BE Statistical Issues

Day 2 – Session 3: Practical Issues in BE Statistics

• ANOVA Design/Analysis Issues: Nuisance effects, ANOVA Model Selection, Missing/Unbalanced Data
  
• Practical Statistical Issues in Evaluation of Average Bioequivalence
  
• The Effect of Adhesion/Detachment on the Pharmacokinetics (PK) of Transdermal Delivery Systems (TDS)
  
• PK and Statistical Considerations for Steady State BE studies – Industry Perspective
  
• PK and Statistical Considerations for Steady State BE studies – FDA Perspective
  
• Panel Discussion on Practical Issues in BE Statistics

Day 2 – Session 4: Modeling in Bioequivalence

• Dose-Scale (E_max) Modeling in Pharmacodynamic BE Studies – Industry Perspective
  
• Dose-Scale (E_max) Modeling in Pharmacodynamic BE Studies – FDA Perspective
  
• Use of Modeling and Simulation to Support New BE Approaches
  
• Panel Discussion on Modeling in Bioequivalence

Quoting from his email:

Although we are describing this as a “statistics” workshop, we will be bringing together statisticians and, importantly, the scientists involved in the generation of in vivo and in vitro bioequivalence data. We are hoping that this collaborative, multidisciplinary approach will help to finally break some of the longstanding logjams that have plagued those of us dealing with BE for years, including outliers/aberrant/messy BE data, dealing with zero C_max and AUC values in data sets, extremely variable drugs (CVs >100%), steady-state BE studies in patients, issues with baseline correction for endogenous drugs, issues with dose-scale (E_max) modeling, and much more. We will have a faculty of well-known speakers, moderators, and panelists, including strong FDA representation.

Sounds extremely interesting!