BEBAC   Ing. Helmut Schütz

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EU-EMA 2014-05-02 Q & A document
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EU-EMA/US-FDA 2013-12-18 Inspec­tions of BE Studies
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US-FDA 2014-05-14 Draft Guidance: Clinical Pharmacology Data to Support a Demon­stra­tion of Biosimilarity to a Reference Product
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US-FDA 2014-03-18 Draft Guidance: BA and BE Studies Sub­mit­ted in NDAs or INDs
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US-FDA 2013-12-09 Draft Guidance on Size, Shape, and Other Phy­si­cal Attri­butes of Gene­ric Tab­lets and Cap­sules
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US-FDA 2013-12-04 Draft Guidance on BE Studies with PK End­points for Drugs Sub­mitted Under an ANDA
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EU-EMA 2013-11-15 Draft product-specific guidances
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US-FDA 2013-09-13 Draft Guidance on Bio­ana­lyti­cal Method Vali­da­tion
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EU-EMA 2013-03-15 Draft Guideline on MR dosage forms
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EU-EMA 2012-09-14 Draft Guidelines on oral MR products and trans­dermal patches (Section I: Quality)
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US-FDA 2012-08-22 Draft Guidance on Self­Identification of Generic Drug Facili­ties, Sites, and Organi­zations
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Consultancy Services for Bioequivalence and Bioavailability Studies

BEBAC specializes in providing biostatistical services, con­tractor selection and supervision. We have wide experience with bioanalytics, pharmacokinetics, and biostatistics.
Our professional expertise covers advisory activities, planning and analysis of Phase I clinical trials.
We are able to support you in planning and evaluation, responding deficiency letters, as well as preparation for regulatory hearings, placement and evaluation of CROs.

Helmut Schütz studied Chemical Engineering in Vienna and is an independent consultant in the domain of bio­availability and bioequivalence studies.
Mr Schütz has worked in the pharmaceutical industry and in an independent CRO, where he established a GLP certified laboratory information management system, holding senior management positions, most recently as the head of a biostatistical department.
He has extensive experience with bioanalytics, pharma­co­kinetics, and biostatistics. His professional experience covers 34 years and more than 500 BA/BE studies.

Helmut Schütz is a member of the Drug Information Asso­ci­a­tion (DIA), the International Pharma­ceutical Fede­ration (FIP), the American Association of Pharma­ceutical Scientists (AAPS), the International Society for Clinical Bio­statistics (ISCB), the International Biometric Society (IBS), the European Network for Business and Industrial Sta­tis­tics (ENBIS), the Austrian Pharma­ceu­ti­cal Asso­ciation (ÖPhG), and the Austrian Association of Con­sulting Engineers (FI).

BEBAC – Consultancy Services for
Bioequivalence and Bioavailability Studies
Ing. Helmut Schütz

Neubaugasse 36/1/11
1070 Vienna, Austria
T: +43 (0)1 2311746
M: +43 (0)699 10792458

document date 2011-05-13 | last update 2014-10-06