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BEBAC • Consultancy Services for Bioequivalence and Bioavailability Studies • Helmut SchützBEBAC – Consultancy Services for Bioequivalence and Bioavailability Studies – Ing. Helmut Schütz
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BEBAC – Consultancy Services for Bioequivalence and Bioavailability Studies – Ing. Helmut Schütz
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BEBAC • Consultancy Services for Bioequivalence and Bioavailability Studies • Helmut Schütz | bebac.at Reviews
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BEBAC – Consultancy Services for Bioequivalence and Bioavailability Studies – Ing. Helmut Schütz
Bioequivalence and Bioavailability Forum
Bioequivalence and Bioavailability Forum. Power / Sample Size. Dissolution / BCS / IVIVC. GxP / QC / QA. Two-Stage / GS Designs. Opinion] Should the 90% CI for GMR be required to encompass 1. Opinion] Should the 90% CI for GMR be required to encompass 1. Opinion] Should the 90% CI for GMR be required to encompass 1. Opinion] Should the 90% CI for GMR be required to encompass 1. Opinion] Should the 90% CI for GMR be required to encompass 1. FDA-Subject by formulation interaction (Switchability). Low AUC a...
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BE/BA-News 2013-11-15
http://bebac.at/news/2013-11-15.htm
EMA promotes consistent development of bioequivalence studies through product-specific guidance. On 15 Nov 2013 EMA released its first product-specific guidance. On the demonstration of bioequivalence for 16 active substances (dated 24 October 2013) for a three-month public consultation period (. Until 15 February 2014). With another wave planned in 2014.*. For each medicine, the document provides guidance in the form of a table on:. Biopharmaceutical classification system (BCS);. Guidances by active ...
BE/BA-News 2013-09-13
http://bebac.at/news/2013-09-13.htm
Draft Guidance for Industry on Bioanalytical Method Validation. On 13 Sep 2013 FDA’s Center for Drug Evaluation and Research (CDER) and Center for Veterinary Medicine (CVM) published the drafted guidance for a 90-day public consultation period (. Until 12 December 2013). Guidance for Industry on Bioanalytical Method Validation. This guidance provides general recommendations for bioanalytical method validation. The recommendations can be modified depending on the specific type of analytical method used.
BEBAC • Data Protection [bebac.at/forum.bebac.at]
http://bebac.at/Data-Protection.htm
Takes your privacy very seriously, and abide strictly by the rules of data protection laws ( Austrian E-Commerce Act. Individual-related data will be collected on this site only to the extent technically necessary. In no case, data are sold or for other reasons circulated to a third party. The following statement gives an overview of how to ensure this protection, and what type of data are collected for what purpose. Data processing at bebac.at. Server request (date-time, file requested),. Address, date-...
BEBAC • Lectures
http://bebac.at/Lectures.htm
Lectures given by Helmut Schütz are released to 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. Which should be followed unreflecting. Nor myself make any representations or warranties regarding the accuracy of such content. 14 16 Nov 2016. Bioequivalence, Dissolution and IVIVC.
BE/BA-News 2013-12-09
http://bebac.at/news/2013-12-09.htm
Draft Guidance for Industry: Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules. On 09 Dec 2013 FDA’s Center for Drug Evaluation and Research (CDER) published the drafted guidance for a 90-day public consultation period (. Until 10 March 2014). Guidance for Industry: Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5). To ensure that the Agency considers your comment on this draft...
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Bioequivalence and Bioavailability Forum • Log-in
http://forum.bebac.at/posting.php?view=mix
Bioequivalence and Bioavailability Forum. Only registered Users can submit posts. Log me in automatically on this computer. In order to log-in, cookies have to be activated! Protected by : ZB BLOCK. Bioequivalence and Bioavailability Forum. 16,739 Posts in 3,590 Threads, 1,036 registered users;. 8 users online (0 registered, 8 guests). If you want to converse with me,. Define your terms. Voltaire. The BIOEQUIVALENCE / BIOAVAILABILITY FORUM.
Bioequivalence and Bioavailability Forum • Sample size justification
http://forum.bebac.at/mix_entry.php?id=15187
Bioequivalence and Bioavailability Forum. Back to the forum. Sample size justification [Design Issues]. I need clarity in the sample size calculation. My straight question, what is the maximum expected sample size (for two way crossover design) with the intra subject coefficient of variation of pilot study data around 15%. Kindly clarify. I have the following data,. Observed Pilot study ISCV% - 12.29%. I wont feel so. If available, kindly share the same. Thanks and Regards,. Balaga Koteswara Rao,. There ...
Bioequivalence and Bioavailability Forum
http://forum.bebac.at/forum.php?view=thread&order=last_answer
Bioequivalence and Bioavailability Forum. Power / Sample Size. Dissolution / BCS / IVIVC. GxP / QC / QA. Two-Stage / GS Designs. 2015-09-08 10:58 [Conferences / Workshops]. 2016-04-14 23:39 [Tips / Tricks]. Why do we need pooled CV? 2016-08-24 08:48 [Power / Sample Size]. Maximum CV might be misleading. Why do we need pooled CV? Common sense weighting before pooling. Gut feeling is the answer! Correct input data to re-calculate results of 3x3x3 study using lm(). 2016-08-24 15:42 [R for BE/BA]. 2014-09-04...
Bioequivalence and Bioavailability Forum • Sample size justification
http://forum.bebac.at/forum_entry.php?id=15185&view=forum
Bioequivalence and Bioavailability Forum. Back to the forum. Sample size justification [Design Issues]. India, 2015-08-06 09:12 - Posting: # 15185. I need clarity in the sample size calculation. My straight question, what is the maximum expected sample size (for two way crossover design) with the intra subject coefficient of variation of pilot study data around 15%. Kindly clarify. I have the following data,. Observed Pilot study ISCV% - 12.29%. I wont feel so. If available, kindly share the same. The BI...
Bioequivalence and Bioavailability Forum • Sample size justification
http://forum.bebac.at/mix_entry.php?id=15185
Bioequivalence and Bioavailability Forum. Back to the forum. Sample size justification [Design Issues]. I need clarity in the sample size calculation. My straight question, what is the maximum expected sample size (for two way crossover design) with the intra subject coefficient of variation of pilot study data around 15%. Kindly clarify. I have the following data,. Observed Pilot study ISCV% - 12.29%. I wont feel so. If available, kindly share the same. Thanks and Regards,. Balaga Koteswara Rao,. There ...
BEBA Forum • Latest 20 posts
http://forum.bebac.at/LatestPosts.htm
Gut feeling is the answer! Power / Sample Size] by. Correct input data to re-calculate results of 3x3x3 study using lm(). R for BE/BA] by. Regulatives / Guidelines] by. Regulatives / Guidelines] by. Correct input data to re-calculate results of 3x3x3 study using lm(). R for BE/BA] by. 1 day 00:36 ago. Common sense weighting before pooling. Power / Sample Size] by. 1 day 01:05 ago. Power / Sample Size] by. 1 day 02:25 ago. Why do we need pooled CV? Power / Sample Size] by. 1 day 03:15 ago. 1 day 04:11 ago.
Bioequivalence and Bioavailability Forum
http://forum.bebac.at/index.php
Bioequivalence and Bioavailability Forum. Power / Sample Size. Dissolution / BCS / IVIVC. GxP / QC / QA. Two-Stage / GS Designs. Why do we need pooled CV? Maximum CV might be misleading. Why do we need pooled CV? Common sense weighting before pooling. Gut feeling is the answer! Power / Sample Size. Correct input data to re-calculate results of 3x3x3 study using lm(). Correct input data to re-calculate results of 3x3x3 study using lm(). Mebeverine Hydrochloride 135 mg S/C Tablet BE Study. OGD's article in...
Instructions for Use
http://forum.bebac.at/Instructions.htm
Bioequivalence and Bioavailability Forum’s. Policy and Terms of Use. S Forum devoted to Bioequivalence and Biovailability. If you are new to the Forum, please read the following Policy Section. Provides a global forum to promote the free exchange of ideas, opinions, and information on Bioavailability (BA) and Bioequivalence (BE) studies. Or related fields and the willingness to begin first with the Search function for similar problems. Of the forum are addressed. The views and opinions expressed by poste...
Bioequivalence and Bioavailability Forum • bear for linux where to download
http://forum.bebac.at/forum_entry.php?id=15183&view=forum
Bioequivalence and Bioavailability Forum. Back to the forum. Bear for linux where to download [R for BE/BA]. Russia, 2015-08-05 16:40 - Posting: # 15183. Download 'bear x.x.x R i686-pc-linux-gnu.tar.gz' (for x86 linux) or 'bear x.x.x R x86 64-pc-linux-gnu.tar.gz' (for x64 linux) first;. Open Terminal and type 'sudo R CMD INSTALL bear x.x.x R i686-pc-linux-gnu.tar.gz' (for x86 linux). One question, where can i download bear x.x.x R i686-pc-linux-gnu.tar.gz. Please, give me link. Back to the forum.
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Just another WordPress.com site. Octubre 11, 2011. Concierto para niños en casa Peseta. Si vives en Madrid. Y tienes niños o te sientes como un niño, tienes una cita este v iernes 14 de octubre. Noviciado, 9). La tienda estrena así un rincón para el disfrute de los más pequeños y la mejor manera de presentarlo es celebrarlo con un concierto de AmyJo. Especializado en niños menores de 5 años. Si te lo estás preguntando, sí, la entrada es libre! Octubre 10, 2011. El nuevo Bugaboo Camaleon. Agosto 29, 2011.
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BEBAC • Consultancy Services for Bioequivalence and Bioavailability Studies • Helmut Schütz
Recent Threads in the Forum. Defintion of estimands in PK studies. Stability of stock and working of stable-isotope labelled IS. Nervous ticks in C - a reminder of the cruel logic of logic. Fed or fasting conditions studies. Error in Number of Subjects. Specific guidelines for psychotropic. Reasons to go for Partial and Full Replicate. IP retention EU regulatory requirements. 95% Upper bound calculation. Agreement between Russia and Belarus for clinical trials (BE). Intra-subject variability from CI.
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Mot de passe :. J'ai oublié mon mot de passe. Du Bepa au Bac. Voici le début d'une classe avec des amitiés fantastiques et des moments inoubliables! Mise à jour :. Abonne-toi à mon blog! Soiré black and withe o lycé. N'oublie pas que les propos injurieux, racistes, etc. sont interdits par les conditions générales d'utilisation de Skyrock et que tu peux être identifié par ton adresse internet (67.219.144.114) si quelqu'un porte plainte. Ou poster avec :. Posté le dimanche 27 juillet 2008 08:22. N'oublie p...
MOJ KREATIVNI HAOS
Недеља, 06. фебруар 2011. Sa zakašnjenjem stiže izvestaj sa izložbe. Sram me bilo, ali šta je tu je :) ). Prvo moram da pohvalim organizatore izložbe. Udruženje Unikatna Umetnost, na čelu sa Jovanom, je fantastično sve organizovalo. Izlagači izuzetni, atmosfera odlična… Sve pohvale. Samo da se ne uobrazimo :) ) Druženje za pamćenje, sa velikom željom da se što skorije ponovi. Jana je bila predstavljena kao najmladji kreativac pa je red i da prvo vidite njene slike. A evo i malo mojih sličica. Ne nisam se...
