Lecture Location Date Event Pitfalls in BA/BE-Studies Brussels 19 Nov 2004 Dissolution Testing, Bioequivalence & Bioavailability Studies Introduction • Dissolution for BA/BE • BA/BE (1/7) • BA/BE (2/7) • BA/BE (3/7) • BA/BE (4/7) • BA/BE (5/7) • BA/BE (6/7) • BA/BE (7/7) Istanbul
7/8 Mar 2006
Regulatory Update and Overview of BE and BA Testing with an Industry Perspective Pitfalls in BA/BE-Studies Budapest 24 May 2006 Dissolution Testing, Bioavailability & Bioequivalence Statistical Evaluation of Bioequivalence Studies Budapest 24 May 2007 Dissolution Testing, Bioavailability & Bioequivalence Getting to grips with statistical aspects of BE studies Berlin 21 Nov 2007 Dissolution Testing, Bioavailability & Bioequivalence Ensuring bioanalytical compliance of your BA/BE study Budapest 14 May 2008 Dissolution, Bioavailability and Bioequivalence Considerations for planning and designing a bioequivalence (BE) study London 27 Jun 2008 Dissolution Testing, Bioequivalence and Bioavailability Strategies Bioequivalence – Still an Applied Science or already a Cookbook? Nuremberg 3/4 Oct 2008 2nd World Conference on Magic Bullets (Ehrlich II) BA/BE design versus ‘job creation scheme’ Prague 7 Oct 2008 Dissolution Testing, Bioavailability and Bioequivalence Study Design and Evaluation Issues: Analytical Development and Validation • Clinical part of Phase I Studies • Statistical Design and Analysis • Q&A Session: Examples અમદાવાદ कर्णावती Ahmedabad1–3 Dec 2008 Bioavailability, Bioequivalence, Pharmacokinetics & beyond… 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 I • Statistical Design and Analysis II • Statistical Design and Analysis III Budapest 11 May 2009 Bioequivalence and Bioavailability 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 I • Statistical Design and Analysis II Successfully Overcoming Sample Size Challenges in BE Studies Ljubljana 17–19 May 2010 Bioequivalence and Bioavailability 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 Munich 25–27 Oct 2010 Bioequivalence and Bioavailability Studies Podcast 3 Aug 2010 (© blogtalkradio )
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Basic Concepts • Basic Designs for BE Studies • Advanced Designs • Sample Size Calculations • Add-On and Sequential Designs मुंबई Mumbai29/30 Jan 2011 Biostatistics: Basic concepts & applicable principles for various designs in bioequivalence studies and data analysis Assessment of bioequivalence of implants: Appropriate study design, metrics, and acceptance criteria Barcelona 24 Feb 2011 Revision of BE Requirements for Modified Release Products Workshop ‘Design and Evaluation of BE Studies’: Overview and Introduction • Noncompartmental Analysis (NCA) in PK, PK based Design • Statistical Design and Analysis I • Statistical Design and Analysis II Determining Optimal Sample Size Budapest 16–18 May 2011 Bioavailability / Bioequivalence and Dissolution Testing 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 Brussels 19–21 Sep 2011 2nd Annual Bioequivalence and Bioavailability Studies Podcast 8 Jul 2011 (© Pharma IQ )
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Transcript Seminar: Practically meeting modified release BE (bioequivalence) requirements Berlin 8 Nov 2011 Innovations in Modified Release Sample Size Calculations • Statistical aspects of two-way cross-over studies • Statistical aspects of reference-scaled studies मुंबई Mumbai27–29 Jan 2012 In vitro in vivo Correlation (IVIVC), Biowaivers & Statistical Aspects of Bioequivalence in Drug Product DevelopmentIntroduction 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 Москва Moscow23–25 May 2012 Advanced practical training on pharmacokinetics, statistics, and analytics in Bioequivalence Studies towards Russian regulatory requirements
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