Publications by authors named "Mario Rocci"

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9
9th GCC closed forum: CAPA in regulated bioanalysis; method robustness, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, regulatory audit experiences and electronic laboratory notebooks.
Roger Hayes, Richard LeLacheur, Isabelle Dumont, Philippe Couerbe, Afshin Safavi, Mario Rocci

Bioanalysis· March 2016

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7th GCC Insights: incurred samples use; fit-for-purpose validation, solution stability, electronic laboratory notebook and hyperlipidemic matrix testing.
Mario Rocci, Steve Lowes, Ronald Shoup, Fabio Garofolo, Raymond Farmen

Bioanalysis· October 2014

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Recommendations on incurred sample stability (ISS) by GCC.
Steve Lowes, Richard LeLacheur, Ronald Shoup, Fabio Garofolo, Isabelle Dumont, Mario Rocci

Bioanalysis· September 2014

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2013 White Paper on recent issues in bioanalysis: 'hybrid'--the best of LBA and LCMS.
Lauren Stevenson, Fabio Garofolo, Binodh DeSilva, Isabelle Dumont, Suzanne Martinez, Mario Rocci

Bioanalysis· December 2013

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Impact of the pharmaceutical sciences on health care: a reflection over the past 50 years.
Malcolm Rowland, Christian R Noe, Dennis A Smith, G T Tucker, Daan J A Crommelin, Mario L Rocci

J Pharm Sci· November 2012

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2012 white paper on recent issues in bioanalysis and alignment of multiple guidelines.
Binodh DeSilva, Fabio Garofolo, Mario Rocci, Suzanne Martinez, Isabelle Dumont

Bioanalysis· September 2012

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2011 White paper on recent issues in bioanalysis and regulatory findings from audits and inspections.
Fabio Garofolo, Mario L Rocci, Isabelle Dumont, Suzanne Martinez, Steve Lowes

Bioanalysis· September 2011

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Recommendations on: internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for Bioanalysis.
Steve Lowes, Jim Jersey, Ronald Shoup, Fabio Garofolo, Natasha Savoie, Mario Rocci

Bioanalysis· June 2011

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Investigation and resolution of incurred sample reanalysis failures: two case studies.
Mario L Rocci, Eileen Collins, Kristine E Wagner-Caruso, Alan D Gibbs, Daniel G Fellows

Bioanalysis· May 2011

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2010 white paper on recent issues in regulated bioanalysis & global harmonization of bioanalytical guidance.
Natasha Savoie, Fabio Garofolo, Peter van Amsterdam, Surendra Bansal, Chris Beaver, Mario L Rocci

Bioanalysis· December 2010

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Formation of a Global Contract Research Organization Council for Bioanalysis.
Noel Premkumar, Stephen Lowes, James Jersey, Fabio Garofolo, Isabelle Dumont, Mario Rocci

Bioanalysis· November 2010

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Challenges and opportunities in establishing scientific and regulatory standards for assuring therapeutic equivalence of modified release products: workshop summary report.
Mei-Ling Chen, Vinod P Shah, Derek Ganes, Kamal K Midha, James Caro, Mario L Rocci

AAPS J· September 2010

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Challenges and opportunities in establishing scientific and regulatory standards for determining therapeutic equivalence of modified-release products: Workshop summary report.
Mei-Ling Chen, Vinod P Shah, Derek Ganes, Kamal K Midha, James Caro, Mario L Rocci

Clin Ther· September 2010

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Challenges and opportunities in establishing scientific and regulatory standards for assuring therapeutic equivalence of modified-release products: workshop summary report.
Mei-Ling Chen, Vinod P Shah, Derek Ganes, Kamal K Midha, James Caro, Mario L Rocci

Eur J Pharm Sci· May 2010

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2
2009 White Paper on recent issues in regulated bioanalysis from the 3rd Calibration and Validation Group Workshop.
Natasha Savoie, Fabio Garofolo, Peter van Amsterdam, Brian P Booth, Douglas M Fast, Mario L Rocci

Bioanalysis· January 2010

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The 2nd Calibration and Validation Group workshop on recent issues in good laboratory practice bioanalysis.
Natasha Savoie, Brian P Booth, Troy Bradley, Fabio Garofolo, Nicola C Hughes, Mario L Rocci

Bioanalysis· April 2009

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Lack of effect of subject posture on intravenous midazolam clearance: implications for hepatic cytochrome P450 3A phenotyping.
Joseph D Ma, Anne N Nafziger, William Mylott, David B Haughey, Mario L Rocci

Br J Clin Pharmacol· March 2009

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Quantitative assessment of hepatic blood flow using intravenous indocyanine green.
Joseph D Ma, Anne N Nafziger, William Mylott, David B Haughey, Mario L Rocci

Eur J Clin Pharmacol· November 2008

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Confirmatory reanalysis of incurred bioanalytical samples.
Mario L Rocci, Viswanath Devanarayan, David B Haughey, Paula Jardieu

AAPS J· October 2007

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Poor correlation between 6beta-hydroxycortisol:cortisol molar ratios and midazolam clearance as measure of hepatic CYP3A activity.
Ya-Chi Chen, S Karl Gotzkowsky, Anne N Nafziger, Robert W Kulawy, Mario L Rocci

Br J Clin Pharmacol· August 2006

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Over-the-counter progesterone cream produces significant drug exposure compared to a food and drug administration-approved oral progesterone product.
Anne C Hermann, Anne N Nafziger, Jennifer Victory, Robert Kulawy, Mario L Rocci

J Clin Pharmacol· June 2005

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An evaluation of the suitability of intravenous midazolam as an in vivo marker for hepatic cytochrome P4503A activity.
Janyce F Rogers, Mario L Rocci, David B Haughey, Joseph S Bertino

Clin Pharmacol Ther· March 2003

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Flumazenil reduces midazolam-induced cognitive impairment without altering pharmacokinetics.
Janyce F Rogers, Ashley L Morrison, Anne N Nafziger, Connie L Jones, Mario L Rocci

Clin Pharmacol Ther· December 2002

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Single plasma concentrations of 1'-hydroxymidazolam or the ratio of 1'-hydroxymidazolam:midazolam do not predict midazolam clearance in healthy subjects.
Janyce F Rogers, Anne N Nafziger, Angela D M Kashuba, Daniel S Streetman, Mario L Rocci

J Clin Pharmacol· October 2002

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Limited sampling strategy to predict AUC of the CYP3A phenotyping probe midazolam in adults: application to various assay techniques.
Jooran S Kim, Anne N Nafziger, Shirley M Tsunoda, Edna E Choo, Daniel S Streetman, Mario L Rocci

J Clin Pharmacol· April 2002

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