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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
Open Access

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

  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
How to measure what happens in pharmacokinetics: PK metrics of relevance! • Pitfalls in BA/BE6/7 OctOberursel
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
5th International Conference of the Global Bioequivalence Har­mo­ni­sation Initiative
tmax Evaluation – Where are we and where will we go…22/23 SepPrague
BioBridges 2022
Bioequivalence – An Old Area with some Uncharted Territories 15 DecVienna
Biometric Colloquium
Steady-State Studies29 AprSão Paulo
Estudos em doses múltiplas para me­di­camentos genéricos e similares de liberação modificada – Con­texto nacional e internacional
Steady-state Studies • Pilot Studies • Two-Stage Designs • Replicate Designs • Outliers in BE11–13 FebCampinas
Network of Scientific Excellence
Similarity and Comparability • Vali­dation and Compliance Issues4–6 NovAthens
Bioequivalence, Dissolution & Bio­wai­vers
Critical aspects regarding – not only – statistical analysis of BE studies. Experiences of a con­sul­tant2 OctVienna
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
Advancing Bioequivalence Regu­la­tion and Competency in Bangla­desh
The General Requirements for Bio­studies7–9 NovAthens
Bioequivalence, Dissolution & IVIVC
Multi-Group Studies in BE. To pool or not to pool?26/27 SepPrague
BioBridges 2018
Multi-Group Studies in BE. To pool or not to pool?24/25 SepAmman
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
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
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
3rd International Conference of the Global Bioequivalence Har­moni­sation Initiative
Validation and Compliance Issues19–21 MarBarcelona
Bioequivalence, Dissolution & IVIVC
Dissolution / Biowaivers / IVIVC5/6 DecKaunas
Training on Bioequivalence
Multi-Group Studies in BE. To pool or not to pool?19/20 OctYaroslavl
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
2nd Annual Biosimilars Forum
How to design a pilot study – extrapolation of results21 SepPrague
BioBridges 2017
General Hurdles and Pitfalls in BE Studies12–14 JunVienna
Bioequivalence, Dissolution & IVIVC
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
Bioequivalence, Dissolution & IVIVC
Sample Size Estimation • Two Stage Designs • Reference-scaling • Software Validation • Case Studies6 OctMoscow
BE Workshop
Two-Stage Sequential Designs: Industry Perspective • Regulatory Perspective22 SepPrague
BioBridges 2016
Inflation of the Type I Error in Refe­rence-scaled Average Bio­equiva­lence16 JunVienna
Pharmacometrics & Biostatistics Meeting
Statistical Planning and Evaluation of Bio­equi­va­lence Studies6 JunLisbon
Scientific and Regulatory Issues in Drug Development and Bio­equi­va­lence
Reference-Scaled Average Bio­equi­va­lence11 MarBilbao
Drug Modeling & Consulting – Group Meeting
Designs for Bio­equiva­lence Stu­dies • Sample Size Estimation for Bio­equi­va­lence Stu­dies19 NovKiev
5th Scientific Conference “Clini­cal Trials of Medicines in Ukra­ine”
Statistical Software in Bio­equi­va­lence19 MayPrague
Bioavailability, Bioequivalence, Dis­so­lu­tion and Biowaivers
Two-Stage Sequential Designs in Bio­equivalence27 JanBarcelona
XII Congreso de la Sociedad Española de Farmacia Industrial y Galénica
Practical Advice for Implement­ing Two-​Stage Designs14 MayBudapest
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
Bioequivalence Studies in Russia: Phar­ma­co­ki­netics, Statistics and Ana­lytics.
Pharmacokinetic Issues: A Basic Refresher7 AprMunich
Haemophilia Master Class: Personalized Treatment and Care
Partial AUCs • Two-Stage Designs in BE-Studies • MR: Cmin – Cτ16 OctPrague
Clinical Development Workshop
Pharmacokinetic and Statistical Analysis of BE Data24 SepAmman
1st MENA Regulatory Conference on Bio­equi­valence, Biowaivers, Bioanalysis and Dissolution
Pharmacokinetic Analysis of BE Data • Statistical Analysis of BE Data5/6 JunLeuven
Bioequivalence Assessment of Oral Dos­age Forms: Basic Concepts and Practical Applications
Experiences in Implementing Two-​Stage Designs in Europe: Tricks and Traps16 MayBudapest
Bioavailability/Bioequivalence, Dis­so­lu­tion and Biowaivers
Sample Size Estimation • Sequential Designs • Introduction to Population PK • Integration in Chromatography19 MarBucharest
Bioequivalence workshop
Reference-Scaled Average Bio­equi­valence (HVDs/​HVDPs) • Two-​Stage Designs • RSABE (NTIDs)25–27 JanMumbai
Advanced concepts of IVIVC through case studies • Bio­sta­tis­tical aspects of Reference-​scaled & Two stage designs: A regulatory perspective
Bioequivalence Studies of Highly Variable Drugs/​Drug Products (HVDs/​HVDPs)Statistics of Two Stage Designs13 DecPrague
Seminar on BE Studies
Sample Size Estimation in BE Studies including Studies with Highly Variable Drugs – Comparison of Russian and EU Guidelines29/30 OctMoscow
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
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
In vitro in vivo Correlation (IVIVC), Bio­waivers & Statistical Aspects of Bio­equi­va­lence in Drug Product Development
Practically meeting modified release BE re­quirements8 NovBerlin
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
2nd Annual Bioequivalence and Bio­avail­ability Studies
Podcast 8 Jul 2011Pharma IQ)
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
Bioavailability / Bioequivalence and Dis­so­lu­tion Testing
Assessment of bioequivalence of implants: Appropriate study design, metrics, and acceptance criteria24 FebBarcelona
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
Biostatistics: Basic concepts & applicable principles for various designs in bio­equi­va­lence studies and data analysis
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
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
Bioequivalence and Bioavailability
Design and Interpretation of BE Studies – Current and Future Issues9 MarBerlin
Hurdles and Pitfalls in Generic Drug Development
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
Bioequivalence and Bioavailability
Analytical Development and Vali­da­tion • Clinical part of Phase I Studies • Statistical Design and Analysis • Q&A Session: Examples1–3 DecAhmeda­bad
Bioavailability, Bioequivalence, Phar­ma­co­kinetics & beyond…
BA/BE design versus ‘job creation scheme’7 OctPrague
Dissolution Testing, Bioavailability and Bioequivalence
Bioequivalence – Still an Applied Science or already a ‘Cookbook’?3/4 OctNurem­berg
2nd World Conference on Magic Bullets (Ehrlich II)
Considerations for planning and designing a bioequivalence (BE) study27 JunLondon
Dissolution Testing, Bio­equi­va­lence and Bio­avail­abi­lity Strate­gies
Ensuring bioanalytical compliance of your BA/BE study14 MayBudapest
Dissolution, Bio­avail­abi­lity and Bio­equi­va­lence
Getting to grips with statistical aspects of BE studies21 NovBerlin
Dissolution Testing, Bio­avail­abi­lity & Bio­equivalence
Statistical Evaluation of Bio­equi­va­lence Studies24 MayBudapest
Dissolution Testing, Bio­avail­abi­lity & Bio­equivalence
Pitfalls in BA/BE-Studies24 MayBudapest
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
Regulatory Update and Overview of BE and BA Testing with an Industry Per­spec­tive
Pitfalls in BA/BE-Studies19 NovBrussels
Dissolution Testing, Bio­equi­va­lence & Bio­avail­abi­lity Studies

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