BEBAC logo   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.

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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
The General Requirements for Bio­studiesAthens
7–9 NovBioequivalence, Dissolution & IVIVC
Multi-Group Studies in BE. To pool or not to pool?Prague
26/27 SepBIOBridges 2018. Bioequivalence and Development Workshop
Multi-Group Studies in BE. To pool or not to pool?Amman
24/25 SepThe 3rd MENA Regulatory Confe­rence On Bioequivalence, Bio­waivers, Bio­analysis and Dissolution
How to measure what happens in pharmacokinetics: PK metrics of relevance! • Pitfalls in BA/BEOberursel
5/6 JunAGAH-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 TopicsPamplona
24 AprBasic 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 assessmentAmsterdam
12/13 Apr3rd International Conference of the Global Bioequivalence Harmonization Initiative
Validation and Compliance IssuesBarcelona
19–21 MarBioequivalence, Dissolution & IVIVC
Dissolution / Biowaivers / IVIVCKaunas
5/6 DecTraining on Bioequivalence
Multi-Group Studies in BE. To pool or not to pool?Yaroslavl
19/20 OctIInd 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 ErrorBudapest
5 Oct2nd Annual Biosimilars Forum
How to design a pilot study – extrapolation of resultsPrague
21 SepBIOBridges 2017. Bioequivalence and Development Workshop
General Hurdles and Pitfalls in BE StudiesVienna
12–14 JunBioequivalence, 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 NovBioequivalence, Dissolution & IVIVC
Sample Size Estimation • Two Stage Designs • Reference-scaling • Software Validation • Case StudiesMoscow
6 OctBE Workshop
Two-Stage Sequential Designs: Industry Perspective • Regulatory PerspectivePrague
22 SepBA/BE Workshop
Inflation of the Type I Error in Reference-scaled Average Bio­equiva­lenceVienna
16 JunPharmacometrics & Biostatistics Meeting
Statistical Planning and Evaluation of Bio­equiva­lence StudiesLisbon
6 JunScientific and Regulatory Issues in Drug Development and Bioequivalence
Reference-Scaled Average Bio­equiva­lenceBilbao
11 MarDrug Modeling & Consulting – Group Meeting
Designs for Bio­equiva­lence Stu­dies • Sample Size Estimation for Bio­equiva­lence Stu­diesKiev
19 Nov5th Scientific Conference “Clini­cal Trials of Medicines in Ukra­ine”
Statistical Software in Bioequi­valencePrague
19 MayBioavailability, Bioequivalence, Dissolution and Biowaivers
Two-Stage Sequential Designs in BioequivalenceBarcelona
27 JanXII Congreso de la Sociedad Española de Farmacia Industrial y Galénica
Practical Advice for Implement­ing Two-​Stage DesignsBudapest
14 MayBioavailability/Bioequivalence, Dissolution and Biowaivers
Basic Designs for BE Studies • Sample Size Estimation for BE Studies • Two-Stage Sequential Designs • Outliers in BE StudiesMoscow
24 AprBioequivalence Studies in Russia: Pharmacokinetics, Statistics and Analytics.
Pharmacokinetic Issues: A Basic RefresherMunich
7 AprHaemophilia Master Class: Personalized Treatment and Care
Partial AUCs • Two-Stage Designs in BE-Studies • Modified Release: Cmin – CτPrague
16 OctClinical Development Workshop
Pharmacokinetic and Statistical Analysis of BE DataAmman
24 Sep1st MENA Regulatory Conference on Bioequivalence, Biowaivers, Bioanalysis and Dissolution
Pharmacokinetic Analysis of BE Data • Statistical Analysis of BE DataLeuven
5/6 JunBioequivalence Assessment of Oral Dosage Forms: Basic Concepts and Practical Applications
Experiences in Implementing Two-​Stage Designs in Europe: Tricks and TrapsBudapest
16 MayBioavailability/Bioequivalence, Dissolution and Biowaivers
Sample Size Estimation • Sequential Designs • Introduction to Population PK • Integration in ChromatographyBucharest
19 MarBioequivalence workshop
Reference-Scaled Average Bio­equi­valence (HVDs/​HVDPs) • Two-​Stage Designs • RSABE (NTIDs)Mumbai
25–27 JanAdvanced 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 DecSeminar on BE Studies
Sample Size Estimation in BE Studies including Studies with Highly Variable Drugs – Comparison of Russian and EU GuidelinesMoscow
29/30 OctDrug 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 MayAdvanced 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 JanIn vitro in vivo Correlation (IVIVC), Biowaivers & Statistical Aspects of Bioequivalence in Drug Product Development
Practically meeting modified release BE re­quirementsBerlin
8 NovInnovations 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 Sep2nd 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 MayBioavailability / Bioequivalence and Dissolution Testing
Assessment of bioequivalence of implants: Appropriate study design, metrics, and acceptance criteriaBarcelona
24 FebRevision 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 JanBiostatistics: 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 OctBioequivalence 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 MayBioequivalence and Bioavailability
Design and Interpretation of BE Studies – Current and Future IssuesBerlin
9 MarHurdles 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 MayBioequivalence and Bioavailability
Analytical Development and Validation • Clinical part of Phase I Studies • Statistical Design and Analysis • Q&A Session: ExamplesAhmeda­bad
1–3 DecBioavailability, Bioequivalence, Pharmacokinetics & beyond…
BA/BE design versus ‘job creation scheme’Prague
7 OctDissolution Testing, Bioavailability and Bioequivalence
Bioequivalence – Still an Applied Science or already a ‘Cookbook’?Nurem­berg
3/4 Oct2nd World Conference on Magic Bullets (Ehrlich II)
Considerations for planning and designing a bioequivalence (BE) studyLondon
27 JunDissolution Testing, Bioequivalence and Bioavailability Strategies
Ensuring bioanalytical compliance of your BA/BE studyBudapest
14 MayDissolution, Bioavailability and Bioequivalence
Getting to grips with statistical aspects of BE studiesBerlin
21 NovDissolution Testing, Bioavailability & Bioequivalence
Statistical Evaluation of Bioequivalence StudiesBudapest
24 MayDissolution Testing, Bioavailability & Bioequivalence
Pitfalls in BA/BE-StudiesBudapest
24 MayDissolution 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 MarRegulatory Update and Overview of BE and BA Testing with an Industry Perspective
Pitfalls in BA/BE-StudiesBrussels
19 NovDissolution Testing, Bioequivalence & Bioavailability Studies

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