2023 Upcoming… 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”Past… Sex– and group–related problems in BE . A delusion. 21/22 Sep PraguePraha BioBridges 2023 Statistical challenges and opportunities in ICH M13A 26 Apr BrusselsBruxelles 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 Global Bioequivalence Harmonisation Initiative t max Evaluation – Where are we and where will we go…22/23 Sep PraguePraha BioBridges 2022 2021 Bioequivalence – An Old Area with some Uncharted Territories 15 Dec ViennaWien Biometric Colloquium Steady-State Studies 29 Apr São Paulo 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 BE 11–13 Feb Campinas Network of Scientific Excellence 2019 Similarity and Comparability • Validation and Compliance Issues 4–6 Nov AthensΑθήνα Bioequivalence, Dissolution & Biowaivers Critical aspects regarding – not only – statistical analysis of BE studies. Experiences of a consultant 2 Oct ViennaWien European Inspectors’ Meeting General Principles of Biostudies • Design of Comparative BA Studies • Regulatory Demands for Biostudies • PK-based Design, Sample Size Considerations • Bioanalytical Method Development and Validation • NCA , Statistical EvaluationGood Clinical Practice • Pitfalls in BE 25–27 Jun Dhakaঢাকা Advancing Bioequivalence Regulation and Competency in Bangladesh 2018 The General Requirements for Biostudies 7–9 Nov AthensΑθήνα Bioequivalence, Dissolution & IVIVC Multi-Group Studies in BE . To pool or not to pool? 26/27 Sep PraguePraha BioBridges 2018 Multi-Group Studies in BE . To pool or not to pool? 24/25 Sep Ammanعمان The 3rd MENA Regulatory Conference On Bioequivalence, 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 PamplonaIruña Basic 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 assessment 12/13 Apr Amsterdam 3rd International Conference of the Global Bioequivalence Harmonisation Initiative Validation and Compliance Issues 19–21 Mar Barcelona Bioequivalence, Dissolution & IVIVC 2017 Dissolution / Biowaivers / IVIVC 5/6 Dec Kaunas Training on Bioequivalence Multi-Group Studies in BE . To pool or not to pool? 19/20 Oct YaroslavlЯросла́вль IInd 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 Error 5 Oct Budapest 2nd Annual Biosimilars Forum How to design a pilot study – extrapolation of results 21 Sep PraguePraha BioBridges 2017 General Hurdles and Pitfalls in BE Studies 12–14 Jun ViennaWien Bioequivalence, 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 Bioequivalence, Dissolution & IVIVC Sample Size Estimation • Two Stage Designs • Reference-scaling • Software Validation • Case Studies 6 Oct MoscowМосква BE WorkshopTwo-Stage Sequential Designs: Industry Perspective • Regulatory Perspective 22 Sep PraguePraha BioBridges 2016 Inflation of the Type I Error in Reference-scaled Average Bioequivalence 16 Jun ViennaWien Pharmacometrics & Biostatistics Meeting Statistical Planning and Evaluation of Bioequivalence Studies 6 Jun LisbonLisboa Scientific and Regulatory Issues in Drug Development and Bioequivalence Reference-Scaled Average Bioequivalence 11 Mar BilbaoBilbo Drug Modeling & Consulting – Group Meeting 2015 Designs for Bioequivalence Studies • Sample Size Estimation for Bioequivalence Studies 19 Nov KievКиїв 5th Scientific Conference “Clinical Trials of Medicines in Ukraine” Statistical Software in Bioequivalence 19 May PraguePraha Bioavailability, Bioequivalence, 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 Bioavailability/Bioequivalence, Dissolution and Biowaivers Basic Designs for BE Studies • Sample Size Estimation for BE Studies • Two-Stage Sequential Designs • Outliers in BE Studies 24 Apr MoscowМосква Bioequivalence Studies in Russia: Pharmacokinetics, Statistics and Analytics. Pharmacokinetic Issues: A Basic Refresher 7 Apr MunichMünchen Haemophilia Master Class: Personalized Treatment and Care 2013 Partial AUCs • Two-Stage Designs in BE -Studies • MR : Cmin – Cτ 16 Oct PraguePraha Clinical Development Workshop Pharmacokinetic and Statistical Analysis of BE Data 24 Sep Ammanعمان 1st MENA Regulatory Conference on Bioequivalence, Biowaivers, Bioanalysis and Dissolution Pharmacokinetic Analysis of BE Data • Statistical Analysis of BE Data 5/6 Jun Leuven Bioequivalence Assessment of Oral Dosage Forms: Basic Concepts and Practical Applications Experiences in Implementing Two-Stage Designs in Europe: Tricks and Traps 16 May Budapest Bioavailability/Bioequivalence, Dissolution and Biowaivers Sample Size Estimation • Sequential Designs • Introduction to Population PK • Integration in Chromatography 19 Mar BucharestBucurești Bioequivalence workshop Reference-Scaled Average Bioequivalence (HVDs /HVDPs ) • Two-Stage Designs • RSABE (NTIDs )25–27 Jan Mumbaiमुंबई Advanced concepts of IVIV C 2012 Bioequivalence Studies of Highly Variable Drugs/Drug Products (HVDs/HVDPs) • Statistics of Two Stage Designs 13 Dec PraguePraha 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 MoscowМосква Drug 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 Studies 23–25 May MoscowМосква Advanced 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 studies 27–29 Jan Mumbaiमुंबई In vitro in vivo Correlation (IVIV C), Biowaivers & Statistical Aspects of Bioequivalence in Drug Product Development2011 Practically meeting modified release BE requirements 8 Nov Berlin Innovations 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 ‘Perfecting’ the two stage study design 19–21 Sep BrusselsBruxelles Brussel 2nd Annual Bioequivalence and Bioavailability Studies
Podcast 8 Jul 2011 (©Pharma IQ )Your browser does not support directly playing audio. You can call it from this link .
Transcript 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 )Determining Optimal Sample Size 16–18 May Budapest Bioavailability / Bioequivalence and Dissolution Testing Assessment of bioequivalence 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 BE Studies • Advanced Designs • Sample Size Calculations • Add-On and Sequential Designs 29/30 Jan Mumbaiमुंबई Biostatistics: Basic concepts & applicable principles for various designs in bioequivalence 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 )Sample Size Challenges in BE Studies and the Myth of Power 25–27 Oct MunichMünchen Bioequivalence and Bioavailability Studies
Podcast 3 Aug 2010 (©blogtalkradio )Your browser does not support directly playing audio. You can call it from this link .
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 )Successfully Overcoming Sample Size Challenges in BE Studies 17–19 May Ljubljana Bioequivalence and Bioavailability Design and Interpretation
of BE Studies – Current and Future Issues 9 Mar Berlin 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: Examples1–3 Dec Ahmedabadઅમદાવાદ कर्णावती Bioavailability, Bioequivalence, Pharmacokinetics & beyond… BA /BE design versus ‘job creation scheme’7 Oct PraguePraha Dissolution Testing, Bioavailability and Bioequivalence 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, Bioequivalence and Bioavailability Strategies Ensuring bioanalytical compliance of your BA /BE study 14 May Budapest Dissolution, Bioavailability and Bioequivalence 2007 Getting to grips with statistical aspects of BE studies 21 Nov Berlin Dissolution Testing, Bioavailability & Bioequivalence Statistical Evaluation of Bioequivalence Studies 24 May Budapest Dissolution Testing, Bioavailability & Bioequivalence 2006 Pitfalls in BA /BE -Studies 24 May Budapest Dissolution Testing, Bioavailability & Bioequivalence Introduction • Dissolution for BA /BE • Bioavailability/Bioequivalence (Part I , Part II , Part III , Part IV , Part V , Part VI , Part VII )7/8 Mar Istanbulİstanbul Regulatory Update and Overview of BE and BA Testing with an Industry Perspective 2004 Pitfalls in BA /BE -Studies 19 Nov BrusselsBruxelles Brussel Dissolution Testing, Bioequivalence & Bioavailability Studies
Ing. Helmut Schütz
