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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

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  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/BE1/2 OctDEOberurselAGAH – Ap­plied Course in Cli­ni­cal Phar­ma­co­ki­ne­tics
Data Manipulation in Bio­equi­va­lence13 JunUSAglobal virtualSAAMnow Spring Work­shop on Data Inte­grity in BE Stu­dies
Highly Variable Drugs and Type I Error16 AprUSARockville6th International Work­shop – GBHI 2024
Data Manipulation in Bio­equi­valence29 NovBEBrussels
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 OctDEFrank­furtExperience meets Ex­per­tise. BE: New Trends and recent Dis­cus­sions.
How to measure what happens in pharmacokinetics: PK metrics of relevance! • Pit­falls in BA/BE5/6 OctDEOberurselAGAH-Workshop “Ap­plied Course in Cli­ni­cal Phar­ma­co­ki­ne­tics”
Sex– and group–related problems in BE. A delusion.21/22 SepCZPrague
BioBridges 2023
Statistical challenges and opportunities in ICH M13A26 AprBEBrussels
Medicines for Eu­rope’s 2nd Bio­equi­va­lence Work­shop
How to measure what happens in phar­ma­cokinetics: PK metrics of relevance! • Pit­falls in BA/BE6/7 OctDEOberurselAGAH-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 SepNLAmsterdam5th International Con­fe­rence of the GBHI
tmax Evaluation – Where are we and where will we go…22/23 SepCZPrague
BioBridges 2022
Bioequivalence – An Old Area with some Uncharted Territories15 DecATglobal virtualBiometric Col­lo­qui­um
Critical Remarks on Reference-Scaled Average Bioequivalence22 OctRUglobal virtual3rd International conference «The life cycle of medicines: simple and complex tasks»
Steady-State Studies29 AprBRglobal virtualEstudos 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 Bioequivalence11–13 FebBRCampinasNetwork of Scien­ti­fic Ex­cel­lence
Similarity and Com­pa­ra­bility • Vali­da­tion and Com­pli­ance Issues4–6 NovGRAthens
BE, Dis­so­lution & Bio­wai­vers
Critical aspects regarding – not only – statistical analysis of BE studies. Ex­pe­ri­ences of a con­sul­tant2 OctATVienna
European In­spec­tors’ Meet­ing
General Principles of Bio­stud­ies • De­sign of Com­pa­rative Bioavailability Studies • Re­gu­la­tory Demands for Bio­stu­dies • PK-based De­sign, Sample Size Con­si­de­ra­tions • Bio­analytical Method De­ve­lopment and Va­li­da­tion • Noncompartmental Ana­lysis, Sta­tis­ti­cal Eva­lu­ation • Good Clinical Prac­tice • Pit­falls in Bioequivalence25–27 JunBDDhaka
Advancing Bio­equi­va­lence Regu­la­tion and Com­pe­tency in Bangla­desh
The General Requirements for Bio­studies7–9 NovGRAthens
BE, Dis­so­lu­tion & IVIVC
Multi-Group Studies in Bioequivalence. To pool or not to pool?26/27 SepCZPrague
BioBridges 2018
Multi-Group Studies in BE. To pool or not to pool?24/25 SepJOAmman
The 3rd MENA Re­gu­la­to­ry Confe­rence On BE, Bio­wai­vers, Bio­ana­lysis and Dis­so­lution
How to measure what happens in phar­ma­cokinetics: PK metrics of relevance! • Pit­falls in BA/BE5/6 JunDEOberurselAGAH-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 AprESPamplona
Basic Statistical Con­cepts Behind BE Testing
Discussion: Scaling procedure and adaptive design(s) • Primary and secondary PK me­trics for evaluation of steady state stu­dies, Cmin vs. Cτ, relevance of Cmin/Cτ or fluc­tuation for bioequivalence assessment12/13 AprNLAmsterdam3rd International Con­fe­rence of the GBHI
Validation and Compliance Issues19–21 MarESBarcelonaBioequivalence, Dis­so­lu­tion & IVIVC
Dissolution / Biowaivers / IVIVC5/6 DecLTKaunasTraining on BE
Multi-Group Studies in Bioequivalence. To pool or not to pool?19/20 OctRUYaroslavl
IInd International Con­fe­rence «Stu­dies of me­di­ci­nal pro­ducts: Simple and com­plex tasks»
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 OctHUBudapest2nd Annual Bio­si­mi­lars Forum
Satellite Short Course: Open Is­sues in the As­sess­ment of BE and Bio­si­mi­la­rity
How to design a pilot stu­dy – extrapolation of results21 SepCZPrague
BioBridges 2017
General Hurdles and Pit­falls in BE Studies12–14 JunATVienna
BE, 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 NovDEBerlinBE, Dis­so­lu­tion & IVIVC
Sample Size Estimation • Two Stage De­signs • Re­fe­rence-scaling • Software Va­li­dation • Case Studies6 OctRUMoscow
BE Workshop
Two-Stage Sequential De­signs: In­du­stry Per­spec­tive • Re­gu­la­tory Per­spec­tive22 SepCZPrague
BioBridges 2016
Inflation of the Type I Error in Re­fe­rence-scaled Av­er­age Bio­equiva­lence16 JunATVienna
Pharmacometrics & Bio­sta­tistics Meeting
Statistical Planning and Eva­lu­a­tion of Bio­equi­valence Stu­dies6 JunPTLisbon
Scientific and Re­gu­la­tory Issues in Drug De­ve­lop­ment and BE
Reference-Scaled Av­er­age Bio­equi­va­lence11 MarESBilbao
Drug Modeling & Con­sult­ing – Group Meeting
Designs for Bio­equi­valence Stu­dies • Sample Size Esti­ma­tion for Bioequivalence Stu­dies19 NovUAKyiv
5th Scien­tific Con­fe­rence “Clini­cal Trials of Me­di­cines in Ukra­ine”
Statistical Software in BE19 MayCZPrague
BA, BE, Dis­so­lu­tion and Bio­wai­vers
Two-Stage Sequential De­signs in Bio­equivalence27 JanESBarcelonaXII Congreso de la So­cie­dad Española de Far­ma­cia In­dus­tri­al y Ga­lé­nica
Practical Advice for Im­ple­ment­ing Two-​Stage Designs14 MayHUBudapestBA, BE, Dis­so­lu­tion and Bio­wai­vers
Basic Designs for BE Stu­dies • Sample Size Esti­ma­tion for BE Studies • Two-Stage Sequential Designs • Outliers in BE Studies24 AprRUMoscow
Bioequivalence Stu­dies in Russia: Phar­ma­co­ki­netics, Sta­tistics and Ana­lytics
Pharmacokinetic Issues: A Basic Refresher7 AprDEMunich
Haemophilia Master Class: Per­so­na­lized Treat­ment and Care
Partial AUCs • Two-Stage Designs in BE Stu­dies • MR: Cmin – Cτ16 OctCZPrague
Clinical De­velop­ment Work­shop
Pharmacokinetic and Sta­tis­tical Ana­lysis of BE Data24 SepJOAmman
1st MENA Re­gu­la­tory Con­fe­rence on BE, Bio­waivers, Bio­ana­lysis and Dis­so­lution
Pharmacokinetic Analysis of BE Data • Statistical Ana­ly­sis of BE Data5/6 JunBELeuven
BE As­sess­ment of Oral Dos­age Forms: Ba­sic Con­cepts and Practical Ap­pli­ca­tions
Experiences in Im­ple­ment­ing Two-​Stage Designs in Europe: Tricks and Traps16 MayHUBudapestBA, BE, Dis­so­lu­tion and Bio­wai­vers
Sample Size Estimation • Se­quen­tial Designs • Intro­duc­tion to Population PK • Integration in Chro­ma­to­graphy19 MarROBucharest
Bioequivalence work­shop
Reference-Scaled Average Bio­equi­valence (HVDs / HVDPs) • Reference-Scaled Aver­age Bio­equi­valence (NTIDs) • Two-​Stage De­signs25–27 JanINMumbai
Advanced concepts of IVIVC through case studies • Bio­sta­tis­tical aspects of Reference-​scaled & Two stage designs: A regulatory perspective
BE Studies of Highly Vari­able Drugs/​Drug Products (HVDs / HVDPs) • Sta­tis­tics of Two Stage De­signs13 DecCZPrague
Seminar on BE Stu­dies
Sample Size Estimation in BE Stu­dies including Stu­dies with Highly Variable Drugs – Com­pa­rison of Rus­sian and EU Guide­lines29/30 OctRUMoscow
Drug development and registration: «Pharma-2020» Im­ple­men­ta­tion Stra­tegy
Introduction to BE • PKNCA, PK based Design, Bio­sta­tistics (Part I, Part II) • De­ve­lop­ment of Bio­ana­lytical Methods for BE Stu­dies • Vali­dation of Bio­ana­ly­tical Methods for BE Studies23–25 MayRUMoscow
Advanced practical training on phar­ma­co­kinetics, statistics, and ana­lytics in BE Stu­dies towards Rus­sian regulatory re­quire­ments
Sample Size Calculations • Sta­tistical aspects of two-way cross-​over studies • Statistical aspects of refe­rence-scaled studies27–29 JanINMumbai
In vitro in vivo Cor­re­la­tion (IVIVC), Bio­wai­vers & Sta­tis­ti­cal As­pects of BE in Drug Pro­duct De­ve­lop­ment
Practically meeting modified release BE re­quirements8 NovDEBerlinInnovations in Mo­di­fied Re­lease
Workshop: 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 SepBEBrussels
2nd Annual BE and BA Stu­dies
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 MayHUBudapestBA / BE and Dis­so­lu­tion Testing
Assessment of BE of implants: Ap­pro­pri­ate study design, metrics, and acceptance criteria24 FebESBarcelonaRevision of BE Re­quire­ments for Mo­di­fied Re­lease Pro­ducts
Basic Concepts • Basic De­signs for Bio­equi­valence Studies • Ad­vanced De­signs • Sample Size Cal­cu­la­tions • Add-On and Se­quen­tial Designs29/30 JanINMumbai
Biostatistics: Basic concepts & applicable principles for va­ri­ous designs in BE 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 OctDEMunich
Bioequivalence and Bio­availability 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 MaySILjubljanaWorkshop ‘Design and Eva­lu­ation of BE Studies’
Design and Interpretation of BE Stu­dies – Current and Future Issues9 MarDEglobal virtualHurdles 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 MayHUBudapestBioequivalence and Bio­availability
Analytical Development and Vali­da­tion • Clinical part of Phase I Stu­dies • Sta­tis­ti­cal Design and Ana­ly­sis • Q&A Session: Examples1–3 DecINAhmeda­bad
Bioavailability, Bio­equi­valence, Phar­ma­co­ki­ne­tics & beyond…
BA/BE design versus ‘job creation scheme’7 OctCZPrague
Dissolution Test­ing, BA and BE
Bioequivalence – Still an Ap­plied Science or already a ‘Cookbook’?3/4 OctDENurem­berg
2nd World Con­fe­rence on Magic Bul­lets (Ehrlich II)
Considerations for planning and designing a bio­equivalence (BE) study27 JunUKLondonDissolution Test­ing, BE and BA Stra­te­gies
Ensuring bioanalytical com­pliance of your BA/BE study14 MayHUBudapestDissolution, BA and BE
Getting to grips with statistical aspects of BE studies21 NovDEBerlinDissolution Test­ing, BA & BE
Statistical Evaluation of BE Studies24 MayHUBudapestDissolution Testing, BA & BE
Pitfalls in BA/BE-Studies24 MayHUBudapestDissolution Test­ing, BA & BE
Introduction • Dissolution for BA/BE • BA/BE (Part I, Part II, Part III, Part IV, Part V, Part VI, Part VII)7/8 MarTRIstanbul
Regulatory Update and Overview of BE and BA Test­ing with an In­dus­try Per­spec­tive
Pitfalls in BA/BE-Studies19 NovBEBrussels
Dissolution Test­ing, BE & BA Stu­dies


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