Helmut
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Vienna, Austria,
2019-03-03 17:24

Posting: # 19989
Views: 483
 

 SAAMnow Spring 2019 Workshop [Conferences / Workshops]

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 (Emax) Modeling in Pharmacodynamic BE Studies – Industry Perspective
  • Dose-Scale (Emax) 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 Cmax 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 (Emax) modeling, and much more. We will have a faculty of well-known speakers, moderators, and panelists, including strong FDA representation.


Sounds extremely interesting!

Cheers,
Helmut Schütz
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The quality of responses received is directly proportional to the quality of the question asked. ☼
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jag009
Hero

NJ,
2019-03-06 19:26

@ Helmut
Posting: # 20003
Views: 387
 

 SAAMnow Spring 2019 Workshop

Hi Helmut!

You going? I want to go take a look, will probably go harass my new boss for money...

John
ElMaestro
Hero

Denmark,
2019-03-07 08:57

@ Helmut
Posting: # 20005
Views: 365
 

 Wow

Thanks Hötzi,

I wish I could attend. I am going in the other direction at that time though. :crying:

How did you find the session details/programme? I could not click my way to it.

if (3) 4

x=c("Foo", "Bar")
b=data.frame(x)
typeof(b[,1]) ##aha, integer?
b[,1]+1 ##then let me add 1



Best regards,
ElMaestro

"(...) targeted cancer therapies will benefit fewer than 2 percent of the cancer patients they’re aimed at. That reality is often lost on consumers, who are being fed a steady diet of winning anecdotes about miracle cures." New York Times (ed.), June 9, 2018.
Ohlbe
Hero

France,
2019-03-07 10:24

@ ElMaestro
Posting: # 20006
Views: 354
 

 Programme

Dear ElMaestro,

» How did you find the session details/programme? I could not click my way to it.

Did you try clicking here ?

What I'm missing is the list of speakers...

Regards
Ohlbe
nobody
Senior

2019-03-07 11:12

@ Ohlbe
Posting: # 20007
Views: 348
 

 Programme

» What I'm missing is the list of speakers...

+1 :-D Gottlieb? He has time now...

Kindest regards, nobody
d_labes
Hero

Berlin, Germany,
2019-03-07 19:57

@ nobody
Posting: # 20010
Views: 307
 

 OT? - Gottlieb?

Dear Odysseus,

» » What I'm missing is the list of speakers...
»
» +1 :-D Gottlieb? He has time now...

who is Gottlieb? And why does he have time?
Did I miss something? Can you enlighten me?

Regards,

Detlew
nobody
Senior

2019-03-07 20:10

@ d_labes
Posting: # 20011
Views: 308
 

 OT? - Gottlieb?

Master of disaster at FDA. Is resigning these days ;-)

Kindest regards, nobody
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