Ing. Helmut Schütz

•     
• Forum
• Guidelines
• Articles
• Lectures
• Contact
• Privacy
• Sitemap

Lectures / Presentations

Selected ones 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 taken into account to a considerable extent, some strong views are strictly scientifically based and do not represent a kind of »cookbook approach« that should be followed without reflection.
Neither BEBAC nor myself make any representations or warranties regarding the accuracy of such content.

Lecture / Presentation	Date		Location	Event
	2025
How to measure what happens in pharmacokinetics: PK metrics of relevance! • Pit­falls in BA/BE	7/8 Oct		Oberursel	AGAH – Applied Course: In­tro­duc­tion into basic prin­cip­les of cli­ni­cal phar­ma­co­ki­ne­tics
Group-by-Treatment Interaction in BE – A Myth or Reality?	10–12 Jun		virtual	SAAMnow Workshop on statistics and data ana­ly­sis in BE
Statistical challenges and opportunities in ICH M13C	26 Feb		Amsterdam	IGBA, Medicines for Eu­rope: 3rd Bio­equi­va­lence Con­fe­rence
	2024
Comparative BA Studies – Fundamentals and Common Pit­falls	5 Nov		Vienna	MedUni Vienna, De­part­ment of Clinical Phar­ma­cology
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

License

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

Further information

If you are interested in workshops/lectures, please contact us by e-mail or use the contact form.