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Lectures / Presentations

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.

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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 / PresentationLocationDateEvent
to be announcedYaroslavl
19/20 Oct 2017II 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? • Multi­group and Multi­site Studies. To pool or not to pool? • Group-Sequential and Two-Stage Designs • Reference-scaling and Control of the Type I ErrorBudapest
5/6 Oct 20172nd Annual Biosimilars Forum
to be anouncedPrague
21/22 Sep 2017BIOBridges 2017. Bioequivalence and Development Workshop
to be anouncedAmman
Sep 20173rd MENA Regulatory Conference on Bioequivalence, Biowaiver, Bioanalysis and Dissolution
General Hurdles and Pitfalls in BE StudiesVienna
12–14 Jun 2017Bioequivalence, 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?Berlin
14–16 Nov 2016Bioequivalence, Dissolution & IVIVC
Sample Size Estimation • Two-Stage Designs • Reference-scaling • Software Validation • Case StudiesMoscow
6 Oct 2016BE Workshop
Two-Stage Sequential Designs: Industry Perspective • Regulatory PerspectivePrague
22 Sep 2016BA/BE Workshop
Inflation of the Type I Error in Reference-scaled ABEVienna
16 Jun 2016Pharmacometrics & Biostatistics Meeting
Statistical Planning and Evaluation of BE StudiesLisbon
6 Jun 2016Scientific and Regulatory Issues in Drug Development and Bioequivalence
Reference-Scaled ABEBilbao
11 Mar 2016Drug Modeling & Consulting – Group Meeting
Designs for BE Studies • Sample Size Estimation for BE StudiesKiev
19 Nov 20155th Scientific Conference “Clinical Trials of Medicines in Ukraine”
Statistical Software in BioequivalencePrague
19 May 2015Bioavailability, Bioequivalence, Dissolution and Biowaivers
Two-Stage Sequential Designs in BioequivalenceBarcelona
27 Jan 2015XII Congreso de la Sociedad Española de Farmacia Industrial y Galénica
Practical Advice for Implementing Two-​Stage DesignsBudapest
14 May 2014Bioavailability/Bioequivalence, Dissolution and Biowaivers
Basic Designs for BE Studies • Sample Size Estimation for BE Studies • Two-Stage Sequential Designs • Outliers in BE StudiesMoscow
24 Apr 2014Bioequivalence Studies in Russia: Pharmacokinetics, Statistics and Analytics.
Pharmacokinetic Issues: A Basic RefresherMunich
7 Apr 2014Haemophilia Master Class: Personalized Treatment and Care
Partial AUCs • Two-Stage Designs in BE-Studies • Modified Release: Cmin – CτPrague
16 Oct 2013Clinical Development Workshop
Pharmacokinetic and Statistical Analysis of BE DataAmman
24 Sep 20131st MENA Regulatory Conference on Bioequivalence, Biowaiver, Bioanalysis and Dissolution
Pharmacokinetic Analysis of BE Data • Statistical Analysis of BE DataLeuven
5/6 Jun 2013Bioequivalence Assessment of Oral Dosage Forms: Basic Concepts and Practical Applications
Experiences in Implementing Two-​Stage Designs in Europe: Tricks and TrapsBudapest
16 May 2013Bioavailability/Bioequivalence, Dissolution and Biowaivers
Sample Size Estimation • Sequential Designs • Introduction to Population PK • Integration in ChromatographyBucharest
19 Mar 2013Bioequivalence workshop
Reference-Scaled Average Bioequivalence (HVDs/​HVDPs) • Two-​Stage Designs • RSABE (NTIDs)Mumbai
25–27 Jan 2013Advanced 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 DesignsPrague
13 Dec 2012Seminar on BE Studies
Sample Size Estimation in BE Studies including Studies with Highly Variable Drugs – Comparison of Russian and EU GuidelinesMoscow
29/30 Oct 2012Drug development and registration: «Pharma-2020» Implementation Strategy
Introduction to Bioequivalence • PK–NCA, PK based Design, Biostatistics (Part I, Part II) • Development of Bioanalytical Methods for BE Studies • Validation of Bioanalytical Methods for BE StudiesMoscow
23–25 May 2012Advanced 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 studiesMumbai
27–29 Jan 2012In vitro in vivo Correlation (IVIVC), Biowaivers & Statistical Aspects of Bioequivalence in Drug Product Development
Practically meeting modified release BE (bioequivalence) requirementsBerlin
8 Nov 2011Innovations 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 Sep 20112nd Annual Bioequivalence and Bio­avail­ability Studies
Podcast 8 Jul 2011Pharma IQ) external Player
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 2011Bioavailability / Bioequivalence and Dissolution Testing
Assessment of bioequivalence of implants: Appropriate study design, metrics, and acceptance criteriaBarcelona
24 Feb 2011Revision of BE Requirements for Modified Release Products
Basic Concepts • Basic Designs for BE Studies • Advanced Designs • Sample Size Calculations • Add-On and Sequential DesignsMumbai
29/30 Jan 2011Biostatistics: 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 Oct 2010Bioequivalence and Bioavailability Studies
Podcast 3 Aug 2010blogtalkradio) external Player
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 May 2010Bioequivalence and Bioavailability
Design and Interpretation of BE Studies – Current and Future IssuesBerlin
9 Mar 2010Hurdles 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)Budapest
11 May 2009Bioequivalence and Bioavailability
Analytical Development and Validation • Clinical part of Phase I Studies • Statistical Design and Analysis • Q&A Session: ExamplesAhmedabad
1–3 Dec 2008Bioavailability, Bioequivalence, Pharmacokinetics & beyond…
BA/BE design versus ‘job creation scheme’Prague
7 Oct 2008Dissolution Testing, Bioavailability and Bioequivalence
Bioequivalence – Still an Applied Science or already a ‘Cookbook’?Nuremberg
3/4 Oct 20082nd World Conference on Magic Bullets (Ehrlich II)
Considerations for planning and designing a bioequivalence (BE) studyLondon
27 Jun 2008Dissolution Testing, Bioequivalence and Bioavailability Strategies
Ensuring bioanalytical compliance of your BA/BE studyBudapest
14 May 2008Dissolution, Bioavailability and Bioequivalence
Getting to grips with statistical aspects of BE studiesBerlin
21 Nov 2007Dissolution Testing, Bioavailability & Bioequivalence
Statistical Evaluation of Bioequivalence StudiesBudapest
24 May 2007Dissolution Testing, Bioavailability & Bioequivalence
Pitfalls in BA/BE-StudiesBudapest
24 May 2006Dissolution Testing, Bioavailability & Bioequivalence
Introduction • Dissolution for BA/​BE • Bioavailability/​Bioequivalence (Part I, Part II, Part III, Part IV, Part V, Part VI, Part VII) Istanbul
7/8 Mar 2006 Regulatory Update and Overview of BE and BA Testing with an Industry Perspective
Pitfalls in BA/BE-StudiesBrussels
19 Nov 2004Dissolution Testing, Bioequivalence & Bioavailability Studies

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