Ing. Helmut Schütz

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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.

License

 Except where otherwise noted, all content is licensed under
Creative Commons Attribution | NonCommercial | ShareAlike 4.0.

Lecture / Presentation	Date		Location	Event
	2025
To be determined	26 Feb		Amsterdam	Medicines for Eu­rope’s 3rd Bio­equi­va­lence Work­shop
	2024
How to measure what happens in pharmacokinetics: PK metrics of relevance! •Pit­falls in BA/BE	1/2 Oct		Oberursel	AGAH – Ap­plied Course in Cli­ni­cal Phar­ma­co­ki­ne­tics
Data Manipulation in Bio­equi­va­lence	13 Jun		virtual	SAAMnow Spring Work­shop on Data Inte­grity in BE Stu­dies
Highly Variable Drugs and Type I Error	16 Apr		Rockville	6th International Work­shop – GBHI 2024
	2023
Data Manipulation in Bio­equi­valence	29 Nov		Brussels Bruxelles Brussel	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 interpretation	11 Oct		Frank­furt	Experience meets Ex­per­tise. BE: New Trends and recent Dis­cus­sions.
How to measure what happens in pharmacokinetics: PK metrics of relevance! • Pit­falls in BA/BE	5/6 Oct		Oberursel	AGAH-Workshop “Ap­plied Course in Cli­ni­cal Phar­ma­co­ki­ne­tics”
Sex– and group–related problems in BE. A delusion.	21/22 Sep		Prague Praha	BioBridges 2023
Statistical challenges and opportunities in ICH M13A	26 Apr		Brussels Bruxelles Brussel	Medicines for Eu­rope’s 2nd Bio­equi­va­lence Work­shop
	2022
How to measure what happens in phar­ma­cokinetics: PK metrics of relevance! • Pit­falls in BA/BE	6/7 Oct		Oberursel	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 SABE	28/29 Sep		Amsterdam	5th International Con­fe­rence of the GBHI
tmax Evaluation – Where are we and where will we go…	22/23 Sep		Prague Praha	BioBridges 2022
	2021
Bioequivalence – An Old Area with some Uncharted Territories	15 Dec		virtual	Biometric Col­lo­qui­um
Critical Remarks on Reference-Scaled Average Bioequivalence	22 Oct		virtual	3rd International conference «The life cycle of medicines: simple and complex tasks»
Steady-State Studies	29 Apr		virtual	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 Bioequivalence	11–13 Feb		Campinas	Network of Scien­ti­fic Ex­cel­lence
	2019
Similarity and Com­pa­ra­bility • Vali­da­tion and Com­pli­ance Issues	4–6 Nov		Athens Αθήνα	BE, Dis­so­lution & Bio­wai­vers
Critical aspects regarding – not only – statistical analysis of BE studies. Ex­pe­ri­ences of a con­sul­tant	2 Oct		Vienna Wien	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 Bioequivalence	25–27 Jun		Dhaka ঢাকা	Advancing Bio­equi­va­lence Regu­la­tion and Com­pe­tency in Bangla­desh
	2018
The General Requirements for Bio­studies	7–9 Nov		Athens Αθήνα	BE, Dis­so­lu­tion & IVIVC
Multi-Group Studies in Bioequivalence. To pool or not to pool?	26/27 Sep		Prague Praha	BioBridges 2018
Multi-Group Studies in BE. To pool or not to pool?	24/25 Sep		Amman عمان	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/BE	5/6 Jun		Oberursel	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 Topics	24 Apr		Pamplona Iruña	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 assessment	12/13 Apr		Amsterdam	3rd International Con­fe­rence of the GBHI
Validation and Compliance Issues	19–21 Mar		Barcelona	Bioequivalence, Dis­so­lu­tion & IVIVC
	2017
Dissolution / Biowaivers / IVIVC	5/6 Dec		Kaunas	Training on BE
Multi-Group Studies in Bioequivalence. To pool or not to pool?	19/20 Oct		Yaroslavl Ярос­ла́вль	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 Error	5 Oct		Budapest	2nd Annual Bio­si­mi­lars Forum Satellite Short Course: Open Is­sues in the As­sess­ment of BE and Bio­si­mi­la­rity
How to design a pilot stu­dy – extrapolation of results	21 Sep		Prague Praha	BioBridges 2017
General Hurdles and Pit­falls in BE Studies	12–14 Jun		Vienna Wien	BE, 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 Nov		Berlin	BE, Dis­so­lu­tion & IVIVC
Sample Size Estimation • Two Stage De­signs • Re­fe­rence-scaling • Software Va­li­dation • Case Studies	6 Oct		Moscow Москва	BE Workshop
Two-Stage Sequential De­signs: In­du­stry Per­spec­tive • Re­gu­la­tory Per­spec­tive	22 Sep		Prague Praha	BioBridges 2016
Inflation of the Type I Error in Re­fe­rence-scaled Av­er­age Bio­equiva­lence	16 Jun		Vienna Wien	Pharmacometrics & Bio­sta­tistics Meeting
Statistical Planning and Eva­lu­a­tion of Bio­equi­valence Stu­dies	6 Jun		Lisbon Lisboa	Scientific and Re­gu­la­tory Issues in Drug De­ve­lop­ment and BE
Reference-Scaled Av­er­age Bio­equi­va­lence	11 Mar		Bilbao Bilbo	Drug Modeling & Con­sult­ing – Group Meeting
	2015
Designs for Bio­equi­valence Stu­dies • Sample Size Esti­ma­tion for Bioequivalence Stu­dies	19 Nov		Kyiv Київ	5th Scien­tific Con­fe­rence “Clini­cal Trials of Me­di­cines in Ukra­ine”
Statistical Software in BE	19 May		Prague Praha	BA, BE, Dis­so­lu­tion and Bio­wai­vers
Two-Stage Sequential De­signs in Bio­equivalence	27 Jan		Barcelona	XII Congreso de la So­cie­dad Española de Far­ma­cia In­dus­tri­al y Ga­lé­nica
	2014
Practical Advice for Im­ple­ment­ing Two-​Stage Designs	14 May		Budapest	BA, BE, Dis­so­lu­tion and Bio­wai­vers
Basic Designs for BE Stu­dies • Sample Size Esti­ma­tion for BE Studies • Two-Stage Sequential Designs • Outliers in BE Studies	24 Apr		Moscow Москва	Bioequivalence Stu­dies in Russia: Phar­ma­co­ki­netics, Sta­tistics and Ana­lytics
Pharmacokinetic Issues: A Basic Refresher	7 Apr		Munich München	Haemophilia Master Class: Per­so­na­lized Treat­ment and Care
	2013
Partial AUCs • Two-Stage Designs in BE Stu­dies • MR: Cmin – Cτ	16 Oct		Prague Praha	Clinical De­velop­ment Work­shop
Pharmacokinetic and Sta­tis­tical Ana­lysis of BE Data	24 Sep		Amman عمان	1st MENA Re­gu­la­tory Con­fe­rence on BE, Bio­waivers, Bio­ana­lysis and Dis­so­lution
Pharmacokinetic Analysis of BE Data • Statistical Ana­ly­sis of BE Data	5/6 Jun		Leuven Louvain	BE As­sess­ment of Oral Dos­age Forms: Ba­sic Con­cepts and Practical Ap­pli­ca­tions
Experiences in Im­ple­ment­ing Two-​Stage Designs in Europe: Tricks and Traps	16 May		Budapest	BA, BE, Dis­so­lu­tion and Bio­wai­vers
Sample Size Estimation • Se­quen­tial Designs • Intro­duc­tion to Population PK • Integration in Chro­ma­to­graphy	19 Mar		Bucharest București	Bioequivalence work­shop
Reference-Scaled Average Bio­equi­valence (HVDs / HVDPs) • Reference-Scaled Aver­age Bio­equi­valence (NTIDs) • Two-​Stage De­signs	25–27 Jan		Mumbai मुंबई	Advanced concepts of IVIVC through case studies • Bio­sta­tis­tical aspects of Reference-​scaled & Two stage designs: A regulatory perspective
	2012
BE Studies of Highly Vari­able Drugs/​Drug Products (HVDs / HVDPs) • Sta­tis­tics of Two Stage De­signs	13 Dec		Prague Praha	Seminar on BE Stu­dies
Sample Size Estimation in BE Stu­dies including Stu­dies with Highly Variable Drugs – Com­pa­rison of Rus­sian and EU Guide­lines	29/30 Oct		Moscow Москва	Drug development and registration: «Pharma-2020» Im­ple­men­ta­tion Stra­tegy
Introduction to BE • PK–NCA, PK based Design, Bio­sta­tistics (Part I, Part II) • De­ve­lop­ment of Bio­ana­lytical Methods for BE Stu­dies • Vali­dation of Bio­ana­ly­tical Methods for BE Studies	23–25 May		Moscow Москва	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 studies	27–29 Jan		Mumbai मुंबई	In vitro in vivo Cor­re­la­tion (IVIVC), Bio­wai­vers & Sta­tis­ti­cal As­pects of BE in Drug Pro­duct De­ve­lop­ment
	2011
Practically meeting modified release BE re­quirements	8 Nov		Berlin	Innovations 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 Sep		Brussels Bruxelles Brussel	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 May		Budapest	BA / BE and Dis­so­lu­tion Testing
Assessment of BE of implants: Ap­pro­pri­ate study design, metrics, and acceptance criteria	24 Feb		Barcelona	Revision of BE Re­quire­ments for Mo­di­fied Re­lease Pro­ducts
Basic Concepts • Basic De­signs for Bio­equi­valence Studies • Ad­vanced De­signs • Sample Size Cal­cu­la­tions • Add-On and Se­quen­tial Designs	29/30 Jan		Mumbai मुंबई	Biostatistics: Basic concepts & applicable principles for va­ri­ous designs in BE 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 Oct		Munich München	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 May		Ljubljana	Workshop ‘Design and Eva­lu­ation of BE Studies’
Design and Interpretation of BE Stu­dies – Current and Future Issues	9 Mar		virtual	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 May		Budapest	Bioequivalence and Bio­availability
	2008
Analytical Development and Vali­da­tion • Clinical part of Phase I Stu­dies • Sta­tis­ti­cal Design and Ana­ly­sis • Q&A Session: Examples	1–3 Dec		Ahmeda­bad અમદાવાદ कर्णावती	Bioavailability, Bio­equi­valence, Phar­ma­co­ki­ne­tics & beyond…
BA/BE design versus ‘job creation scheme’	7 Oct		Prague Praha	Dissolution Test­ing, BA and BE
Bioequivalence – Still an Ap­plied Science or already a ‘Cookbook’?	3/4 Oct		Nurem­berg Nürnberg	2nd World Con­fe­rence on Magic Bul­lets (Ehrlich II)
Considerations for planning and designing a bio­equivalence (BE) study	27 Jun		London	Dissolution Test­ing, BE and BA Stra­te­gies
Ensuring bioanalytical com­pliance of your BA/BE study	14 May		Budapest	Dissolution, BA and BE
	2007
Getting to grips with statistical aspects of BE studies	21 Nov		Berlin	Dissolution Test­ing, BA & BE
Statistical Evaluation of BE Studies	24 May		Budapest	Dissolution Testing, BA & BE
	2006
Pitfalls in BA/BE-Studies	24 May		Budapest	Dissolution 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 Mar		Istanbul İstanbul	Regulatory Update and Overview of BE and BA Test­ing with an In­dus­try Per­spec­tive
	2004
Pitfalls in BA/BE-Studies	19 Nov		Brussels Bruxelles Brussel	Dissolution Test­ing, BE & BA Stu­dies

Podcasts

• Transcript

White papers

• Evaluation of Replicate Designs for Average Bioequivalence according to the EMA’s Guideline with Phoenix™ WinNonlin^®
  • v2.6 (Phoenix ≤6.2.1) September 2011
  • v3.4 (Phoenix 6.3) March 2013
• Evaluation of Replicate Designs for (Reference Scaled) Average Bioequivalence according to the FDA’s Guidance with Phoenix™ WinNonlin^®
  • v1.1 (Phoenix 6.3) August 2012

Further information

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