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BEBAC Ing. Helmut Schütz

Lectures / Presentations

Selected lectures given by Helmut Schütz are open access and released to the public domain.

The content expressed in the lectures presents a sole personal opinion.
Although regulatory requirements – which might change rather quickly – are incorporated to a high degree; some strong views are strictly scientifically based and do not represent any type of “cookbook approach” which should be followed unreflecting.
Neither BEBAC nor myself make any representations or warranties regarding the accuracy of such content.

The true Enlightenment thinker, the true rationalist,
never wants to talk anyone into anything.
No, he does not even want to convince;
all the time he is aware that he may be wrong.
– Karl R. Popper
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Open Access

Creative Commons License Except where otherwise noted, content on this page is licensed
under Creative Commons Attribution | NonCommercial | ShareAlike 4.0.

Disclaimer
  1. Anybody using or relying upon information or opinions set out in the lectures, does so at their own risk.
  2. BEBAC strongly advises that independent professional judgment be exercised and/​or independent professional advice should be sought before using or relying upon such information or opinions.
Lecture / PresentationDateLocationEvent
2024
How to measure what happens in pharmacokinetics: PK metrics of relevance! • Pitfalls in BA/BE1/2 OctOberursel
DE
AGAH-Workshop “Applied Course in Clinical Pharmacokinetics”
HVD and Type I Error16 AprRockville
US
5th International Workshop – GBHI 2024
2023
Data Manipulation in Bioequivalence29 NovBrussels
Bruxelles
Brussel
BE
Medicines for Europe’s BE Working Party meeting
ICH M13A: testing for multi-group- and multi-center–effects in comparative BA trials: statistical considerations and consequences for interpretation11 OctFrank­furt
DE
Experience meets Expertise.
BE: New Trends and recent Dis­cus­sions.
How to measure what happens in pharmacokinetics: PK metrics of relevance! • Pitfalls in BA/BE5/6 OctOberursel
DE
AGAH-Workshop “Applied Course in Clinical Pharmacokinetics”
Sex– and group–related problems in BE. A delusion.21/22 SepPrague
Praha
CZ
BioBridges 2023
Statistical challenges and opportunities in ICH M13A26 AprBrussels
Bruxelles
Brussel
BE
Medicines for Europe’s 2nd Bio­equi­valence Workshop
2022
How to measure what happens in pharmacokinetics: PK metrics of relevance! • Pitfalls in BA/BE6/7 OctOberursel
DE
AGAH-Workshop “Introduction into Basic Principles of Phar­ma­co­ki­netics”
Novel approaches in adaptive designs and α adjustment, e.g., with futility criteria and for parallel design studies • Discussion | Consumer risk in SABE28/29 SepAmsterdam
NL
5th International Conference of the Global Bioequivalence Har­mo­ni­sation Initiative
tmax Evaluation – Where are we and where will we go…22/23 SepPrague
Praha
CZ
BioBridges 2022
2021
Bioequivalence – An Old Area with some Uncharted Territories 15 DecVienna
Wien
AT
Biometric Colloquium
Steady-State Studies29 AprSão Paulo
BR
Estudos em doses múltiplas para me­di­camentos genéricos e similares de liberação modificada – Con­texto nacional e internacional
2020
Steady-state Studies • Pilot Studies • Two-Stage Designs • Replicate Designs • Outliers in BE11–13 FebCampinas
BR
Network of Scientific Excellence
2019
Similarity and Comparability • Vali­dation and Compliance Issues4–6 NovAthens
Αθήνα
GR
Bioequivalence, Dissolution & Bio­wai­vers
Critical aspects regarding – not only – statistical analysis of BE studies. Experiences of a con­sul­tant2 OctVienna
Wien
AT
European Inspectors’ Meeting
General Principles of Biostudies • Design of Comparative BA Studies • Regulatory Demands for Biostudies • PK-based Design, Sample Size Con­siderations • Bioanalytical Method Development and Validation • NCA, Statistical Evaluation • Good Clinical Practice • Pitfalls in BE25–27 JunDhaka
ঢাকা
BD
Advancing Bioequivalence Regu­la­tion and Competency in Bangla­desh
2018
The General Requirements for Bio­studies7–9 NovAthens
Αθήνα
GR
Bioequivalence, Dissolution & IVIVC
Multi-Group Studies in BE. To pool or not to pool?26/27 SepPrague
Praha
CZ
BioBridges 2018
Multi-Group Studies in BE. To pool or not to pool?24/25 SepAmman
عمان
JO
The 3rd MENA Regulatory Confe­rence On Bioequivalence, Bio­waivers, Bio­analysis and Dis­so­lution
How to measure what happens in pharmacokinetics: PK metrics of relevance! • Pitfalls in BA/BE5/6 JunOberursel
DE
AGAH-Workshop “Introduction into Basic Principles of Phar­ma­co­ki­netics”
Basic Statistics for BE • Sample Size Estimation • Group-Sequential and Two-Stage Designs • Reference-scaling and Control of the Type I Error • Nonparametric Statistics (tmax, tlag) • Special Topics24 AprPamplona
Iruña
ES
Basic Statistical Concepts Behind BE Testing
Scaling procedure and adaptive design(s) | Discussion • Primary and secondary PK me­trics for evaluation of steady state studies, Cmin vs. Cτ, relevance of Cmin/Cτ or fluc­tuation for BE assessment12/13 AprAmsterdam
NL
3rd International Conference of the Global Bioequivalence Har­moni­sation Initiative
Validation and Compliance Issues19–21 MarBarcelona
ES
Bioequivalence, Dissolution & IVIVC
2017
Dissolution / Biowaivers / IVIVC5/6 DecKaunas
LT
Training on Bioequivalence
Multi-Group Studies in BE. To pool or not to pool?19/20 OctYaroslavl
Ярос­ла́вль
RU
IInd International Conference «Stu­dies of medicinal products: Simple and com­plex tasks»
Open Issues in the Assessment of Bioequivalence and Bio­similarity: Unequal carry­over – “solved” in BE but still an Issue in Assessing Bio­simi­larity? • Multi-Group and Mul­ti-Site Studies. To pool or not to pool? • Group-Sequential and Two-Stage Designs • Reference-scaling and Control of the Type I Error5 OctBudapest
HU
2nd Annual Biosimilars Forum
How to design a pilot study – extrapolation of results21 SepPrague
Praha
CZ
BioBridges 2017
General Hurdles and Pitfalls in BE Studies12–14 JunVienna
Wien
AT
Bioequivalence, Dissolution & IVIVC
2016
The General Requirements for Bio­studies • Establishing the Bio­study Statistical Design: Part I, Part II • Pilot Studies • Similarity, Comparability and Correlation • Soft­ware Validation • General Hurdles and Pitfalls in BE Studies • Where are we going with Dissolution and BE Studies?14–16 NovBerlin
DE
Bioequivalence, Dissolution & IVIVC
Sample Size Estimation • Two Stage Designs • Reference-scaling • Software Validation • Case Studies6 OctMoscow
Москва
RU
BE Workshop
Two-Stage Sequential Designs: Industry Perspective • Regulatory Perspective22 SepPrague
Praha
CZ
BioBridges 2016
Inflation of the Type I Error in Refe­rence-scaled Average Bio­equiva­lence16 JunVienna
Wien
AT
Pharmacometrics & Biostatistics Meeting
Statistical Planning and Evaluation of Bio­equi­va­lence Studies6 JunLisbon
Lisboa
PT
Scientific and Regulatory Issues in Drug Development and Bio­equi­va­lence
Reference-Scaled Average Bio­equi­va­lence11 MarBilbao
Bilbo
ES
Drug Modeling & Consulting – Group Meeting
2015
Designs for Bio­equiva­lence Stu­dies • Sample Size Estimation for Bio­equi­va­lence Stu­dies19 NovKyiv
Київ
UA
5th Scientific Conference “Clini­cal Trials of Medicines in Ukra­ine”
Statistical Software in Bio­equi­va­lence19 MayPrague
Praha
CZ
Bioavailability, Bioequivalence, Dis­so­lu­tion and Biowaivers
Two-Stage Sequential Designs in Bio­equivalence27 JanBarcelona
ES
XII Congreso de la Sociedad Española de Farmacia Industrial y Galénica
2014
Practical Advice for Implement­ing Two-​Stage Designs14 MayBudapest
HU
Bioavailability/Bioequivalence, Dis­so­lu­tion and Biowaivers
Basic Designs for BE Studies • Sample Size Estimation for BE Studies • Two-Stage Sequential Designs • Outliers in BE Studies24 AprMoscow
Москва
RU
Bioequivalence Studies in Russia: Phar­ma­co­ki­netics, Statistics and Ana­lytics.
Pharmacokinetic Issues: A Basic Refresher7 AprMunich
München
DE
Haemophilia Master Class: Personalized Treatment and Care
2013
Partial AUCs • Two-Stage Designs in BE-Studies • MR: Cmin – Cτ16 OctPrague
Praha
CZ
Clinical Development Workshop
Pharmacokinetic and Statistical Analysis of BE Data24 SepAmman
عمان
JO
1st MENA Regulatory Conference on Bio­equi­valence, Biowaivers, Bioanalysis and Dissolution
Pharmacokinetic Analysis of BE Data • Statistical Analysis of BE Data5/6 JunLeuven
Louvain
BE
Bioequivalence Assessment of Oral Dos­age Forms: Basic Concepts and Practical Applications
Experiences in Implementing Two-​Stage Designs in Europe: Tricks and Traps16 MayBudapest
HU
Bioavailability/Bioequivalence, Dis­so­lu­tion and Biowaivers
Sample Size Estimation • Sequential Designs • Introduction to Population PK • Integration in Chromatography19 MarBucharest
București
RO
Bioequivalence workshop
Reference-Scaled Average Bio­equi­valence (HVDs/​HVDPs) • Two-​Stage Designs • RSABE (NTIDs)25–27 JanMumbai
मुंबई
IN
Advanced concepts of IVIVC through case studies • Bio­sta­tis­tical aspects of Reference-​scaled & Two stage designs: A regulatory perspective
2012
Bioequivalence Studies of Highly Variable Drugs/​Drug Products (HVDs/​HVDPs)Statistics of Two Stage Designs13 DecPrague
Praha
CZ
Seminar on BE Studies
Sample Size Estimation in BE Studies including Studies with Highly Variable Drugs – Comparison of Russian and EU Guidelines29/30 OctMoscow
Москва
RU
Drug development and registration: «Pharma-2020» Imple­men­ta­tion Strategy
Introduction to Bioequivalence • PKNCA, PK based Design, Biostatistics (Part I, Part II) • Development of Bioanalytical Methods for BE Stu­dies • Validation of Bioanalytical Methods for BE Studies23–25 MayMoscow
Москва
RU
Advanced practical training on phar­ma­co­kinetics, statistics, and ana­lytics in Bio­equivalence Studies towards Russian regulatory requirements
Sample Size Calculations • Sta­tistical aspects of two-way cross-​over studies • Statistical aspects of refe­rence-scaled studies27–29 JanMumbai
मुंबई
IN
In vitro in vivo Correlation (IVIVC), Bio­waivers & Statistical Aspects of Bio­equi­va­lence in Drug Product Development
2011
Practically meeting modified release BE re­quirements8 NovBerlin
DE
Innovations in Modified Release
Workshops: Setting up a BE study: from design to appro­val • Power and intra-subject variability in 2 stage approaches to bioequivalence approval
Presentation: ‘Perfecting’ the two stage study design
19–21 SepBrussels
Bruxelles
Brussel
BE
2nd Annual Bioequivalence and Bio­avail­ability Studies
Podcast 8 Jul 2011Pharma IQ)
Transcript
Workshop ‘Design and Evaluation of BE Studies’: Overview and Intro­duction • Noncompartmental Ana­lysis (NCA) in PK, PK based Design • Statistical Design and Analysis (Part I, Part II)
Presentation: Determining Optimal Sample Size
16–18 MayBudapest
HU
Bioavailability / Bioequivalence and Dis­so­lu­tion Testing
Assessment of bioequivalence of implants: Appropriate study design, metrics, and acceptance criteria24 FebBarcelona
ES
Revision of BE Requirements for Modified Release Products
Basic Concepts • Basic Designs for BE Studies • Advanced Designs • Sample Size Calculations • Add-On and Sequential Designs29/30 JanMumbai
मुंबई
IN
Biostatistics: Basic concepts & applicable principles for various designs in bio­equi­va­lence studies and data analysis
2010
Workshop ‘Taking a Biostatistical Approach to Designing a BE Study: Ensuring Success through Effective Planning’ (Part I, Part II, Part III)
Presentation: Sample Size Chal­lenges in BE Studies and the Myth of Power
25–27 OctMunich
München
DE
Bioequivalence and Bioavailability Studies
Podcast 3 Aug 2010blogtalkradio)
Workshop ‘Design and Evaluation of BE Studies’: Overview and Intro­duc­tion • Analytical Development and Validation • Clinical Part of BA/​BE studies • Noncompartmental Ana­lysis (NCA) in PK, PK-​based Design • Statistical Design and Analysis (Part I, Part II)
Presentation: Successfully Over­coming Sample Size Challenges in BE Studies
17–19 MayLjubljana
SI
Bioequivalence and Bioavailability
Design and Interpretation of BE Studies – Current and Future Issues9 MarBerlin
DE
Hurdles and Pitfalls in Generic Drug Development
2009
Best Design of BE Studies: Overview and Introduction • Analytical Deve­lop­ment and Validation • Clinical part of BA/BE studies • Noncompartmental Analysis (NCA) in PK, PK-based Design • Statistical Design and Analysis (Part I, Part II, Part III)11 MayBudapest
HU
Bioequivalence and Bioavailability
2008
Analytical Development and Vali­da­tion • Clinical part of Phase I Studies • Statistical Design and Analysis • Q&A Session: Examples1–3 DecAhmeda­bad
અમદાવાદ
कर्णावती
IN
Bioavailability, Bioequivalence, Phar­ma­co­kinetics & beyond…
BA/BE design versus ‘job creation scheme’7 OctPrague
Praha
CZ
Dissolution Testing, Bioavailability and Bioequivalence
Bioequivalence – Still an Applied Science or already a ‘Cookbook’?3/4 OctNurem­berg
Nürnberg
DE
2nd World Conference on Magic Bullets (Ehrlich II)
Considerations for planning and designing a bioequivalence (BE) study27 JunLondon
UK
Dissolution Testing, Bio­equi­va­lence and Bio­avail­abi­lity Strate­gies
Ensuring bioanalytical compliance of your BA/BE study14 MayBudapest
HU
Dissolution, Bio­avail­abi­lity and Bio­equi­va­lence
2007
Getting to grips with statistical aspects of BE studies21 NovBerlin
DE
Dissolution Testing, Bio­avail­abi­lity & Bio­equivalence
Statistical Evaluation of Bio­equi­va­lence Studies24 MayBudapest
HU
Dissolution Testing, Bio­avail­abi­lity & Bio­equivalence
2006
Pitfalls in BA/BE-Studies24 MayBudapest
HU
Dissolution Testing, Bio­avail­abi­lity & Bio­equivalence
Introduction • Dissolution for BA/​BE • Bioavailability/​Bioequivalence (Part I, Part II, Part III, Part IV, Part V, Part VI, Part VII)7/8 MarIstanbul
İstanbul
TR
Regulatory Update and Overview of BE and BA Testing with an Industry Per­spec­tive
2004
Pitfalls in BA/BE-Studies19 NovBrussels
Bruxelles
Brussel
BE
Dissolution Testing, Bio­equi­va­lence & Bio­avail­abi­lity Studies

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