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Impact of the Pharmaceutical Sciences on Health Care: A Reflection over the Past 50 Years

Journal of pharmaceutical sciences, 2012-11, Vol.101 (11), p.4075-4099

2012

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Regulated Bioanalysis: Fundamentals and Practice

2017

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2010 white paper on recent issues in regulated bioanalysis & global harmonization of bioanalytical guidance

Bioanalysis, 2010-12, Vol.2 (12), p.1945-1960

2010

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The 2nd Calibration and Validation Group workshop on recent issues in good laboratory practice bioanalysis

Bioanalysis, 2009-04, Vol.1 (1), p.19-30

2009

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Lack of effect of subject posture on intravenous midazolam clearance: implications for hepatic cytochrome P450 3A phenotyping

British journal of clinical pharmacology, 2009-03, Vol.67 (3), p.374-375

2009

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Confirmatory reanalysis of incurred bioanalytical samples

The AAPS journal, 2007-10, Vol.9 (3), p.E336-E343

2007

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Over-the-Counter Progesterone Cream Produces Significant Drug Exposure Compared to a Food and Drug Administration-Approved Oral Progesterone Product

Journal of clinical pharmacology, 2005-06, Vol.45 (6), p.614-619

2005

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Regulated Bioanalysis

1, 2017

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2009 White Paper on recent issues in regulated bioanalysis from the 3rd Calibration and Validation Group Workshop

Bioanalysis, 2010-01, Vol.2 (1), p.53-68

2010

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An evaluation of the suitability of intravenous midazolam as an in vivo marker for hepatic cytochrome P4503A activity

Clinical pharmacology and therapeutics, 2003-03, Vol.73 (3), p.153-158

2003

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Challenges and opportunities in establishing scientific and regulatory standards for assuring therapeutic equivalence of modified-release products: Workshop summary report

European journal of pharmaceutical sciences, 2010-05, Vol.40 (2), p.148-153

2010

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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

Journal of clinical pharmacology, 2002-10, Vol.42 (10), p.1079-1082

2002

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Fundamentals of LC-MS/MS for Regulated Bioanalysis

Regulated Bioanalysis: Fundamentals and Practice, 2017, Vol.26, p.103-120

2017

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Investigation and resolution of incurred sample reanalysis failures: two case studies

Bioanalysis, 2011-05, Vol.3 (9), p.993-1000

2011

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Development and Maintenance of Critical Reagents for Ligand Binding Assays to Support Regulatory-Compliant Bioanalysis

Regulated Bioanalysis: Fundamentals and Practice, 2017, Vol.26, p.155-176

2017

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Logistical and Operational Practice in the Regulated Bioanalysis Laboratory

Regulated Bioanalysis: Fundamentals and Practice, 2017, Vol.26, p.39-62

2017

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Quantitative assessment of hepatic blood flow using intravenous indocyanine green

European journal of clinical pharmacology, 2008-11, Vol.64 (11), p.1133-1134

2008

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Flumazenil reduces midazolam-induced cognitive impairment without altering pharmacokinetics

Clinical pharmacology and therapeutics, 2002-12, Vol.72 (6), p.711-717

2002

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Limited Sampling Strategy to Predict AUC of the CYP3A Phenotyping Probe Midazolam in Adults: Application to Various Assay Techniques

Journal of clinical pharmacology, 2002-04, Vol.42 (4), p.376-382

2002

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Limited Sampling Strategy to Predict AUC of the CYP3A Phenotyping Probe Midazolam in Adults: Application to Various Assay Techniques

Journal of clinical pharmacology, 2002-04, Vol.42 (4), p.376-382

2002

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Poor correlation between 6beta-hydroxycortisol:cortisol molar ratios and midazolam clearance as measure of hepatic CYP3A activity

British journal of clinical pharmacology, 2006-08, Vol.62 (2), p.187

2006

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Introduction

Regulated Bioanalysis: Fundamentals and Practice, 2017, p.1-13

2017

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Impact of the Pharmaceutical Sciences on Health Care: A Reflection over the Past 50 Years

Regulated Bioanalysis: Fundamentals and Practice

2010 white paper on recent issues in regulated bioanalysis & global harmonization of bioanalytical guidance

The 2nd Calibration and Validation Group workshop on recent issues in good laboratory practice bioanalysis

Lack of effect of subject posture on intravenous midazolam clearance: implications for hepatic cytochrome P450 3A phenotyping

Confirmatory reanalysis of incurred bioanalytical samples

Over-the-Counter Progesterone Cream Produces Significant Drug Exposure Compared to a Food and Drug Administration-Approved Oral Progesterone Product

2011 White paper on recent issues in bioanalysis and regulatory findings from audits and inspections

Regulated Bioanalysis

2009 White Paper on recent issues in regulated bioanalysis from the 3rd Calibration and Validation Group Workshop

An evaluation of the suitability of intravenous midazolam as an in vivo marker for hepatic cytochrome P4503A activity

Challenges and opportunities in establishing scientific and regulatory standards for assuring therapeutic equivalence of modified-release products: Workshop summary report

Single Plasma Concentrations of 1′-Hydroxymidazolam or the Ratio of 1′-Hydroxymidazolam: Midazolam Do Not Predict Midazolam Clearance in Healthy Subjects

Challenges and opportunities in establishing scientific and regulatory standards for determining therapeutic equivalence of modified-release products: Workshop summary report

Fundamentals of LC-MS/MS for Regulated Bioanalysis

Investigation and resolution of incurred sample reanalysis failures: two case studies

Challenges and Opportunities in Establishing Scientific and Regulatory Standards for Assuring Therapeutic Equivalence of Modified Release Products: Workshop Summary Report

Development and Maintenance of Critical Reagents for Ligand Binding Assays to Support Regulatory-Compliant Bioanalysis

Logistical and Operational Practice in the Regulated Bioanalysis Laboratory

Quantitative assessment of hepatic blood flow using intravenous indocyanine green

Flumazenil reduces midazolam-induced cognitive impairment without altering pharmacokinetics

Limited Sampling Strategy to Predict AUC of the CYP3A Phenotyping Probe Midazolam in Adults: Application to Various Assay Techniques

Limited Sampling Strategy to Predict AUC of the CYP3A Phenotyping Probe Midazolam in Adults: Application to Various Assay Techniques

Poor correlation between 6beta-hydroxycortisol:cortisol molar ratios and midazolam clearance as measure of hepatic CYP3A activity

Introduction

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