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The New Big Is Small: Leveraging Knowledge from Small Trials for Rare Disease Drug Development - Blarcamesine for Rett Syndrome

British journal of clinical pharmacology, 2023-08

2023

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Demographics of clinical trials participants in pivotal clinical trials for new molecular entity drugs and biologics approved by FDA From 2010 to 2012

American journal of therapeutics, 2015-11, Vol.22 (6), p.435

2015

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Alcohol and Aldehyde Dehydrogenases Contribute to Sex-Related Differences in Clearance of Zolpidem in Rats

Frontiers in pharmacology, 2016-08, Vol.7, p.260-260

2016

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Representation of Women and Minorities in Clinical Trials for New Molecular Entities and Original Therapeutic Biologics Approved by FDA CDER from 2013 to 2015

Journal of women's health (Larchmont, N.Y. 2002), 2018-04, Vol.27 (4), p.418

2018

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Population‐Based Characterization of the Pharmacokinetics and Food Effect of ANAVEX3‐71, a Novel Sigma‐1 Receptor and Allosteric M1 Muscarinic Receptor Agonist in Development for Treatment of Frontotemporal Dementia, Schizophrenia, and Alzheimer Disease

Clinical pharmacology in drug development, 2024-01, Vol.13 (1), p.21-31

2024

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Concentration–QTc Relationship from a Single Ascending Dose Study of ANAVEX3‐71, a Novel Sigma‐1 Receptor and Allosteric M1 Muscarinic Receptor Agonist in Development for the Treatment of Frontotemporal Dementia, Schizophrenia, and Alzheimer's Disease

Clinical pharmacology in drug development, 2023-09, Vol.12 (9), p.888-901

2023

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CRT-800.07 Demographics of Study Participants in Clinical Trials for Cardiovascular Drugs Approved by FDA CDER From January to September 2015

JACC. Cardiovascular interventions, 2016-02, Vol.9 (4), p.S64-S64

2016

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Adverse effects in women: implications for drug development and regulatory policies

Expert review of clinical pharmacology, 2011-07, Vol.4 (4), p.453-466

2011

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The Food and Drug Administration Office of Women's Health: Impact of Science on Regulatory Policy: An Update

Journal of women's health (Larchmont, N.Y. 2002), 2016-03, Vol.25 (3), p.222

2016

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CRT-115 Demographics Of Study Participants In Clinical Trials For Cardiovascular Drugs Approved By FDA From 2010 To 2011

JACC. Cardiovascular interventions, 2013-02, Vol.6 (2), p.S37-S37

2013

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The science of sex and gender in human health: online courses to create a foundation for sex and gender accountability in biomedical research and treatment

Biology of sex differences, 2016-10, Vol.7 (Suppl 1), p.47-47, Article 47

2016

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Abstract 11144: Demographics of Study Participants in Clinical Trials for Cardiovascular Drugs Approved at FDA CDER From 2013 to 2014

Circulation (New York, N.Y.), 2015-11, Vol.132 (Suppl_3 Suppl 3), p.A11144-A11144

2015

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DT‐01‐05: SYSTEMATIC PROCESSING OF FULL GENOMIC ANALYSIS OF THE ANAVEX®2‐73 PHASE 2A ALZHEIMER'S DISEASE STUDY IDENTIFIES BIOMARKERS ENABLING A PRECISION MEDICINE APPROACH

Alzheimer's & dementia, 2018-07, Vol.14 (7S_Part_31), p.P1666-P1667

2018

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FULL GENOMIC ANALYSIS OF ANAVEX®2-73 PHASE 2A ALZHEIMER’S DISEASE STUDY IDENTIFIES BIOMARKERS ENABLING TARGETED THERAPY AND A PRECISION MEDICINE APPROACH

Alzheimer's & dementia, 2018-07, Vol.14 (7), p.P1519-P1520

2018

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P4‐206: FULL GENOMIC ANALYSIS OF ANAVEX®2‐73 PHASE 2A ALZHEIMER'S DISEASE STUDY IDENTIFIES BIOMARKERS ENABLING TARGETED THERAPY AND A PRECISION MEDICINE APPROACH

Alzheimer's & dementia, 2018-07, Vol.14 (7S_Part_29), p.P1519-P1520

2018

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SYSTEMATIC PROCESSING OF FULL GENOMIC ANALYSIS OF THE ANAVEX®2-73 PHASE 2A ALZHEIMER’S DISEASE STUDY IDENTIFIES BIOMARKERS ENABLING A PRECISION MEDICINE APPROACH

Alzheimer's & dementia, 2018-07, Vol.14 (7), p.P1666-P1667

2018

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Second-derivative spectrofluorimetric determination of sulphoxide impurity in phenothiazine drug substances and formulations

Analyst (London), 1990, Vol.115 (7), p.997

1990

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Population pharmacokinetics : A regulatory perspective

Clinical pharmacokinetics, 1999-07, Vol.37 (1), p.41-58

1999

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Effect of variation of temperature on second-derivative fluorescence spectra. Part II. Effect of experimental parameters on the observed temperature coefficients

Analyst (London), 1988, Vol.113 (4), p.537

1988

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Effect of variation of temperature on second-derivative fluorescence spectra. Part I. Spectral changes and uncorrected temperature coefficients

Analyst (London), 1988, Vol.113 (4), p.533

1988

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Effect of variation of temperature on second-derivative fluorescence spectra. Part III. Correction of temperature coefficients for solvent scatter interference

Analyst (London), 1988, Vol.113 (4), p.543

1988

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Adverse effects in women: implications for drug development and regulatory policies

Expert review of clinical pharmacology, 2011-07, Vol.4 (4), p.453

2011

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Stability of ticarcillin disodium in polypropylene syringes

American journal of health-system pharmacy, 1995-04, Vol.52 (8), p.890, 892

1995

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The New Big Is Small: Leveraging Knowledge from Small Trials for Rare Disease Drug Development - Blarcamesine for Rett Syndrome

Demographics of clinical trials participants in pivotal clinical trials for new molecular entity drugs and biologics approved by FDA From 2010 to 2012

Alcohol and Aldehyde Dehydrogenases Contribute to Sex-Related Differences in Clearance of Zolpidem in Rats

Representation of Women and Minorities in Clinical Trials for New Molecular Entities and Original Therapeutic Biologics Approved by FDA CDER from 2013 to 2015

Population‐Based Characterization of the Pharmacokinetics and Food Effect of ANAVEX3‐71, a Novel Sigma‐1 Receptor and Allosteric M1 Muscarinic Receptor Agonist in Development for Treatment of Frontotemporal Dementia, Schizophrenia, and Alzheimer Disease

Concentration–QTc Relationship from a Single Ascending Dose Study of ANAVEX3‐71, a Novel Sigma‐1 Receptor and Allosteric M1 Muscarinic Receptor Agonist in Development for the Treatment of Frontotemporal Dementia, Schizophrenia, and Alzheimer's Disease

TransRadial Education And Therapeutics (TREAT): Shifting the balance of safety and efficacy of antithrombotic agents in percutaneous coronary intervention

CRT-800.07 Demographics of Study Participants in Clinical Trials for Cardiovascular Drugs Approved by FDA CDER From January to September 2015

Adverse effects in women: implications for drug development and regulatory policies

The Food and Drug Administration Office of Women's Health: Impact of Science on Regulatory Policy: An Update

CRT-115 Demographics Of Study Participants In Clinical Trials For Cardiovascular Drugs Approved By FDA From 2010 To 2011

The science of sex and gender in human health: online courses to create a foundation for sex and gender accountability in biomedical research and treatment

TransRadial Education and Therapeutics (TREAT): shifting the balance of safety and efficacy of antithrombotic agents in percutaneous coronary intervention: a report from the Cardiac Safety Research Consortium

Abstract 11144: Demographics of Study Participants in Clinical Trials for Cardiovascular Drugs Approved at FDA CDER From 2013 to 2014

DT‐01‐05: SYSTEMATIC PROCESSING OF FULL GENOMIC ANALYSIS OF THE ANAVEX®2‐73 PHASE 2A ALZHEIMER'S DISEASE STUDY IDENTIFIES BIOMARKERS ENABLING A PRECISION MEDICINE APPROACH

FULL GENOMIC ANALYSIS OF ANAVEX®2-73 PHASE 2A ALZHEIMER’S DISEASE STUDY IDENTIFIES BIOMARKERS ENABLING TARGETED THERAPY AND A PRECISION MEDICINE APPROACH

P4‐206: FULL GENOMIC ANALYSIS OF ANAVEX®2‐73 PHASE 2A ALZHEIMER'S DISEASE STUDY IDENTIFIES BIOMARKERS ENABLING TARGETED THERAPY AND A PRECISION MEDICINE APPROACH

SYSTEMATIC PROCESSING OF FULL GENOMIC ANALYSIS OF THE ANAVEX®2-73 PHASE 2A ALZHEIMER’S DISEASE STUDY IDENTIFIES BIOMARKERS ENABLING A PRECISION MEDICINE APPROACH

Second-derivative spectrofluorimetric determination of sulphoxide impurity in phenothiazine drug substances and formulations

Population pharmacokinetics : A regulatory perspective

Effect of variation of temperature on second-derivative fluorescence spectra. Part II. Effect of experimental parameters on the observed temperature coefficients

Effect of variation of temperature on second-derivative fluorescence spectra. Part I. Spectral changes and uncorrected temperature coefficients

Effect of variation of temperature on second-derivative fluorescence spectra. Part III. Correction of temperature coefficients for solvent scatter interference

Adverse effects in women: implications for drug development and regulatory policies

Stability of ticarcillin disodium in polypropylene syringes

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