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BEBAC • Data Protection [bebac.at/forum.bebac.at]

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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-...

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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Draft Guidance for Industry: Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules.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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BE/BA-News 2013-03-15

http://bebac.at/news/2013-03-15.htm

Draft guideline on modified release dosage forms. On 15 Mar 2013 EMA’s Quality Working Party (QWP) published the drafted guideline (dated 21 February 2013) for a six-month public consultation period (. Until 15 September 2013). Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms. Comments should be provided using this template. And sent to PKWPsecretariat@ema.europa.eu. Document date 2013-03-15 last update 2015-04-23.

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BE/BA-News 2013-12-04

http://bebac.at/news/2013-12-04.htm

Draft Guidance for Industry: Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA. On 04 Dec 2013 FDA’s Center for Drug Evaluation and Research (CDER) published the drafted guidance for a 90-day public consultation period (. Until 05 March 2014). Guidance for Industry: Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5).

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BE/BA-News 2009-01-22

http://bebac.at/news/2009-01-22.htm

Pharmacokinetics Working Party (PKWP) published ‘Questions and Answers: Positions on specific questions addressed to the Pharmacokinetics Working Party’. EMEA/618604/2008 Rev. 13. 19 November 2015, published 03 March 2016; for previous versions see the end of the page. In the context of assessment procedures, the Pharmacokinetics Working Party (PKWP), or its predecessor the Therapeutic Subgroup on Pharmacokinetics of the Efficacy Working Party (EWP-PK subgroup), is occasionally consulted by the. This com...

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PK/PD: Bioavailability/Bioequivalence Guidelines

http://pk-pd.blogspot.com/2008/10/bioavailabilitybioequivalence.html

A blog with random discussions on pharmacokinetics, pharmacodynamics and drug development. Tuesday, October 7, 2008. Abbreviated New Drug Application), you may want to bookmark this page and become familiar with following documents. Note: All links have been updated (March 2014). 1 Bioavailability and Bioequivalence Studies for Orally Administered Drug Products - General Considerations (Issued 3/2003, Posted 3/19/2003)[ PDF. NEW DRAFT FOR COMMENTS. 10 Bioanalytical Method Validation (05/2001)[ PDF. This ...

pk-pd.blogspot.com

PK/PD: Clinical Pharmacokinetic Studies in Drug Development

http://pk-pd.blogspot.com/2009/06/clinical-pharmacokinetic-studies-in.html

A blog with random discussions on pharmacokinetics, pharmacodynamics and drug development. Tuesday, June 16, 2009. Clinical Pharmacokinetic Studies in Drug Development. Here goes the list. 1 Single Ascending Dose (SAD). 2 Multiple Ascending Dose (MAD). 3 Food Effect Studies. 4 ADME Mass Balance Studies. 6 Thorough QTc Study. 7 Drug Interaction Studies - Enzyme Inhibition/Induction. 8 Effect of Age and Gender. 9 Special Population - Hepatic Impairment. 10 Special Populaiton - Renal Impairment. I will be b...

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PK/PD: Human Microdosing Studies/ Phase Zero

http://pk-pd.blogspot.com/2008/04/human-microdosing-studies-phase-zero.html

A blog with random discussions on pharmacokinetics, pharmacodynamics and drug development. Friday, April 25, 2008. Human Microdosing Studies/ Phase Zero. A Phase Zer0 study involves evaluating pharmacokinetics of a drug after administration of sub-therapeutic or sub pharmacology doses to a small group of healthy volunteers. According to. Microdose is defined as dose less than 1/100th of the dose calculated to yield a pharmacological effect or a maximum of. Acceleratoor mass spectrometry (AMS). As such, t...

pk-pd.blogspot.com

PK/PD: June 2013

http://pk-pd.blogspot.com/2013_06_01_archive.html

A blog with random discussions on pharmacokinetics, pharmacodynamics and drug development. Saturday, June 15, 2013. The Role of Clinical Pharmacology in the Trial of Conrad Murray. One of the key highlights of ASCPT 2013 was the presentation by Dr. Shafer on " The Role of Clinical Pharmacology in the Trial of Conrad Murray. This is a practical example of the utility of PK/PD modeling and simulation. So, sit back and enjoy the presentation. Links to this post. Subscribe to: Posts (Atom).

pk-pd.blogspot.com

PK/PD: June 2009

http://pk-pd.blogspot.com/2009_06_01_archive.html

A blog with random discussions on pharmacokinetics, pharmacodynamics and drug development. Tuesday, June 16, 2009. Clinical Pharmacokinetic Studies in Drug Development. Here goes the list. 1 Single Ascending Dose (SAD). 2 Multiple Ascending Dose (MAD). 3 Food Effect Studies. 4 ADME Mass Balance Studies. 6 Thorough QTc Study. 7 Drug Interaction Studies - Enzyme Inhibition/Induction. 8 Effect of Age and Gender. 9 Special Population - Hepatic Impairment. 10 Special Populaiton - Renal Impairment. I will be b...