Ing. Helmut Schütz

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Lectures

Lectures given by Helmut Schütz in the last years (as PDF-files) are made available in 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.

Except where otherwise noted, content on this site
is licensed under a Creative Commons Attribution 3.0 License.

Disclaimer

• Anybody using or relying upon information or opinions set out in the lectures, does so at their own risk.
• BEBAC strongly advises that independent professional judgment be exercised and/or independent professional advice should be sought before using or relying upon such informations or opinions.

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 Ahmedabad	1-3 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 Presentation: Successfully Overcoming Sample Size Challenges in BE Studies	Ljubljana	17-19 May 2010	Bioequivalence and Bioavailability
Upcoming…
Workshop ‘Taking a Biostatistical Approach to Designing a Bioequivalence Study: Ensuring Success through Effective Planning’ Presentation: ‘Sample Size Challenges in BE Studies and the Myth of Power’	Munich	25-27 Oct 2010	Bioequivalence and Bioavailability Studies Podcast 3 Aug 2008 (©Pharma iQ ©blogtalkradio)

Further information

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