Scientific factors in biosimilar product development
![]() Professor Emeritus of Pharmacology and Biostatistics, University of Toronto; Former President of Canadian Society for Pharmaceutical Scientists |
![]() Professor Emeritus of Pharmacology and Biostatistics, University of Toronto; Former President of Canadian Society for Pharmaceutical Scientists |
Available only for
visitors of the 1st Course day.
![]() Helmut Schütz, Owner at BEBAC – Consultancy Services for Bioequivalence and Bioavailability Studies |
Available only for
visitors of the 1st Course day.
|
![]() Associate Professor, Faculty of Pharmacology, Semmelweis Medical University, Budapest |
![]() Professor Emeritus of Pharmacology and Biostatistics, University of Toronto; Former President of Canadian Society for Pharmaceutical Scientists |
![]() Unit Head, Austrian Medicines and Medical Devices Agency |
![]() Biostatistician, Seconded National Expert from Klinikum rechts der Isar of Technische Universität München to EMA |
![]() Director of the Nanomedicine Research and Education Center, Semmelweis Medical University, Budapest, Professor at University of Miskolc, Dep. of Nanobiotechnology and the Regenerative Medicine, Institute of Theoretical Medicine |
![]() Biostatistician, Austrian Medicines and Medical Devices Agency, President, Viennese Section of IBS |
![]() Head of Biostatistics, Sandoz Biopharmaceuticals |
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Title:
Presenters:
The short course presents robust methods for the assessment of both average and of scaled average bioequivalence, based on data from conventional cross-over studies and replicate design cross-over studies. Initially, in an empirical study of a large number of average bioequivalence studies, the results of the (i) classic, (ii) conventional nonparametric and (iii) Bayesian robust analyses are compared, and the need for robust analyses is discussed. Thereafter, the classic and Bayesian robust methods are applied to a group of replicate design bioequivalence studies, and diagnostic plots and outlier diagnostics for such studies are presented. Robust analysis of replicate design bioequivalence data affects not only the estimation of the location parameters of the test and reference formulations, but also the within-reference scaling factor; a proposal is made for the appropriate handling of this matter. The proposed Bayesian robust methodology is flexible with regard to study design (conventional cross-over, replicate design cross-over, parallel design) and with regard to the handling of outliers and skewness in the data.
Thank you for your interest in our Annual Biosimilars Forum! This page has been designed for the purpose of providing information to you about our data protection as required by the EU General Data Protection Regulation (Regulation (EU) 2016/679, hereinafter referred to as the „GDPR”).
We at Accelsiors are committed to protecting your privacy and with that in mind, we have developed our ’Privacy Notice for Business Partners’ to make it easier for you to understand what information we collect, why we collect it and how we use it to clarify how you can make choices about your information and the measures we have put in place to keep your information secure.
If you have any questions about these data protection rules, please contact us by using the contact information provided below.
This notice applies to information held about you and your delegates registered to our Annual Biosimilars Forum (“Forum”) by members of the Accelsiors Group as data controllers, as described below. It explains what information we collect about you and individuals who are connected to your business in connection with your registration to the Forum, how we’ll use that information, who we’ll share it with, the circumstances when we’ll share it, and what steps we’ll take to make sure it stays private and secure.
The types of data we collect, and process in connection with your registration to the Forum are the data provided by you on our registration form. That includes:
Any data regarding your registration and our communications is recorded by Accelsiors directly.
The personal data of your delegates will be used to set up your contact in our Client Relationship Management („CRM”) system which enables us to manage our interaction with you and your delegates to provide information on the Forum.
The legal basis for processing your personal data is the performance concluded between you and Accelsiors in connection with the Forum. Also, some data may be processed even after the conclusion of the Forum based on the legitimate interest of Accelsiors, since this type of processing may help Accelsiors to contact potential study Sponsors with the hope of a successful cooperation in conducting clinical trials.
If you provide us with your consent, we will make contact with you for marketing purposes through any particular contact info provided by you through the registration sheet (such as email, telephone or post). However, if you do not give us your consent, or you withdraw such consent at any time, we will immediately stop making contact with you for marketing purposes.
The data is being collected and controlled by Accelsiors Kft. (hereinafter referred to as “Accelsiors”), a Hungarian company with its headquarters in Budapest, Miskolci Street, no. 50. with the contact information as follows:
At Accelsiors, we are committed to protecting your privacy. Accelsiors is a company established in the European Union and, consequently, your study data will be processed in accordance with the applicable European Union law. Your personal data will be recorded in our secure CRM system.
Accelsiors will share your personal data only with its affiliates and/or agents/service providers. Your personal data will be transferred to its affiliates outside of the European Union only if either:
Accelsiors will keep your personal data for a period of 5 years from the conclusion of the Forum.
You have the following rights in relation to the processing of your data:
To exercise any of these rights, please contact us at [email protected], or by mail to Accelsiors, Ltd., 103 Haros street, 1222, Budapest, Hungary, Attention: Privacy. We will respond to your request within a reasonable timeframe and notify you of the action we have taken.