BEBAC   Ing. Helmut Schütz

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News

EMA 2015-11-19 Q & A document
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EMA/FDA 2013-12-18 Inspec­tions of BE Studies
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Guidance

EMA 2014-11-20 Guide­line on MR dosage forms
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EMA 2014-10-23 Guide­line on similar bio­lo­gical medicinal products
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FDA 2014-05-14 Draft Guid­ance: Clinical Phar­ma­co­logy Data to Sup­port a Demon­stra­tion of Biosimilarity to a Re­fe­rence Product
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FDA 2014-03-18 Draft Guid­ance: BA and BE Studies Sub­mit­ted in NDAs or INDs
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FDA 2013-12-09 Draft Guid­ance on Size, Shape, and Other Phy­si­cal Attri­butes of Gene­ric Tab­lets and Cap­sules
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FDA 2013-12-04 Draft Guid­ance on BE Studies with PK End­points for Drugs Sub­mitted Under an ANDA
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EMA 2013-11-15 Draft pro­duct-specific guid­ance
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FDA 2013-09-13 Draft Guid­ance on Bio­ana­lyti­cal Method Vali­da­tion
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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 bio­sta­tis­tics, phar­ma­co­ki­netics, and bio­analytics.
Our professional expertise covers advisory activities, plan­ning and analysis of Phase I clinical trials.
We are able to support you in design­ing and eval­u­ating stu­dies, responding deficiency letters, as well as in the pre­pa­ration for regulatory hearings, as­sess­ment 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 GA­LP-certified LIMS and held 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 36 years and more than 600 BA/BE stu­dies.


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

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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
E: office@bebac.at
W: http://bebac.at/
F: http://forum.bebac.at/

document date 2011-05-13 | last update 2016-07-20

shortlived