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The Utilization Of Venous-Venous Extracorporeal Membrane Oxygenation Membrane For The Management Of Status Asthmaticus, Kenneth Miller MSRT, MEd, RRT-ACCS, FAARC,, Jennifer Strow DO, Alison N. Bedekovich MSN, RN 2018 Lehigh Valley Health Network

The Utilization Of Venous-Venous Extracorporeal Membrane Oxygenation Membrane For The Management Of Status Asthmaticus, Kenneth Miller Msrt, Med, Rrt-Accs, Faarc,, Jennifer Strow Do, Alison N. Bedekovich Msn, Rn

Patient Care Services / Nursing

No abstract provided.


Cystic Fibrosis Gene Therapy: Looking Back, Looking Forward, Ashley L. Cooney, Paul B. McCray, Patrick L. Sinn 2018 University of Iowa

Cystic Fibrosis Gene Therapy: Looking Back, Looking Forward, Ashley L. Cooney, Paul B. Mccray, Patrick L. Sinn

Stead Family Department of Pediatrics Publications

Cystic fibrosis (CF) is an autosomal recessive disease caused by mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that encodes a cAMP-regulated anion channel. Although CF is a multi-organ system disease, most people with CF die of progressive lung disease that begins early in childhood and is characterized by chronic bacterial infection and inflammation. Nearly 90% of people with CF have at least one copy of the ΔF508 mutation, but there are hundreds of CFTR mutations that result in a range of disease severities. A CFTR gene replacement approach would be efficacious regardless of the disease-causing mutation. After ...


Can Non-Small Cell Lung Cancer Histologic Subtypes Predict Survival? A Single Institution Experience, Cornelia Nitipir, Cristina Orlov, Ana-Maria Popa, Mihaela Olaru, Iulian Slavu, Iaciu Cristian, Razvan Hainarosie, Anca Pantea Stoian, Balalau Cristian 2018 Carol Davila University of Medicine and Pharmacy, Elias University Emergency Hospital, Department of Oncology, Bucharest, Romania

Can Non-Small Cell Lung Cancer Histologic Subtypes Predict Survival? A Single Institution Experience, Cornelia Nitipir, Cristina Orlov, Ana-Maria Popa, Mihaela Olaru, Iulian Slavu, Iaciu Cristian, Razvan Hainarosie, Anca Pantea Stoian, Balalau Cristian

Journal of Mind and Medical Sciences

Introduction. The latest histological classification of lung adenocarcinoma includes lepidic, acinar, papillary, micropapillary, and solid as subtypes. Testing these subtypes for their prognostic and predictive value is an ongoing scientific challenge. The present research article aims to describe the influence this classification has on patient survival.

Materials and Methods. Thirty-three patients were included in the trial. The most important enrollment criterion was the clear specification of the adenocarcinoma subtype in the pathology report. Patients were stratified into three groups which included the adenocarcinoma pathological subtypes as follows: lepidic (LEP), acinar and papillary (ACN/PAP), and micropapillary/solid (MIP/SOL). The ...


Use Of Ultrasound For Diagnosis Of Pneumonia In Adults, A Review, Dafang Chen, Rodrigo Cavallazzi 2018 University of Louisville

Use Of Ultrasound For Diagnosis Of Pneumonia In Adults, A Review, Dafang Chen, Rodrigo Cavallazzi

The University of Louisville Journal of Respiratory Infections

Pneumonia is a common lung infection with significant morbidity and mortality. Currently, the diagnosis of pneumonia is made by patient history confirmed with chest radiograph or computed tomography. These modalities, however, have limitations including low accuracy, radiation exposure, and high cost. Lung ultrasound has become more prevalent in evaluating pulmonary conditions and has shown to be highly accurate in the diagnosis of pneumonia. The purpose of this review is to discuss sonographic findings associated with pneumonia, techniques used to obtain quality images, and the evidence in literature supporting the use of lung ultrasound in the diagnosis of pneumonia. Numerous studies ...


Comparison Of Mortality And Therapy In Community Acquired Pneumonia, Gina Maki, Daniela Moreno, Anthony Harris, Steven Lawrence, Andrew Masica, Lois Lamerato, Marcus J. Zervos 2018 Henry Ford Health System

Comparison Of Mortality And Therapy In Community Acquired Pneumonia, Gina Maki, Daniela Moreno, Anthony Harris, Steven Lawrence, Andrew Masica, Lois Lamerato, Marcus J. Zervos

The University of Louisville Journal of Respiratory Infections

Background: Community associated pneumonia (CAP) is one the most common causes of hospital admissions, exceeding more than one million per year in the United States, contributing to 3.4% of inpatient mortality. Our objective was to compare 30-day mortality using therapies recommended for treatment of CAP.

Methods: A multicenter retrospective analysis from four different hospitals was assessed from 2008 to 2013. The data was obtained from electronic medical records which included more than 70,000 patients. CAP patients were identified using discharge diagnostic codes during the years 2008-2013, as well as receiving therapy with ceftriaxone and azithromycin or a respiratory ...


The Association Of Qsofa, Sofa, And Sirs With Mortality In Emergency Department Pneumonia, Ian D. Mecham, Nathan C. Dean, Emily L. Wilson, Al R. Jephson, Michael J. Lanpsa 2018 University of Utah

The Association Of Qsofa, Sofa, And Sirs With Mortality In Emergency Department Pneumonia, Ian D. Mecham, Nathan C. Dean, Emily L. Wilson, Al R. Jephson, Michael J. Lanpsa

The University of Louisville Journal of Respiratory Infections

Objective: To determine the association between 30-day mortality with Systemic Inflammatory Response Syndrome (SIRS), Sequential Organ Failure Assessment (SOFA), and quick SOFA (qSOFA) in emergency department patients with pneumonia. Secondary outcomes included the association of sepsis scores with hospital admission and direct ICU admission.

Methods: This is a secondary analysis of a pneumonia population conducted in the emergency department of 3 tertiary care medical centers and 4 community hospitals. Adult immunocompetent patients diagnosed with pneumonia were included from 3 twelve-month periods spanning December 2009 to October 2015. We generated area under the receiver operating characteristic curve (AUC) values for each ...


Identification Of Susceptibility Pathways For The Role Of Chromosome 15q25.1 In Modifying Lung Cancer Risk., Xuemei Ji, Yohan Bossé, Maria Teresa Landi, Jiang Gui, Xiangjun Xiao, David Qian, Philippe Joubert, Maxime Lamontagne, Yafang Li, Ivan Gorlov, Mariella de Biasi, Younghun Han, Olga Gorlova, Rayjean J Hung, Xifeng Wu, James McKay, Xuchen Zong, Robert Carreras-Torres, David C Christiani, Neil Caporaso, Mattias Johansson, Geoffrey Liu, Stig E Bojesen, Loic Le Marchand, Demetrios Albanes, Heike Bickeböller, Melinda C Aldrich, William S Bush, Adonina Tardon, Gad Rennert, Chu Chen, M Dawn Teare, John K Field, Lambertus A Kiemeney, Philip Lazarus, Aage Haugen, Stephen Lam, Matthew B Schabath, Angeline S Andrew, Hongbing Shen, Yun-Chul Hong, Jian-Min Yuan, Pier A Bertazzi, Angela C Pesatori, Yuanqing Ye, Nancy Diao, Li Su, Ruyang Zhang, Yonathan Brhane, Natasha Leighl, Jakob S Johansen, Anders Mellemgaard, Walid Saliba, Christopher Haiman, Lynne Wilkens, Ana Fernandez-Somoano, Guillermo Fernandez-Tardon, Erik H F M van der Heijden, Jin Hee Kim, Juncheng Dai, Zhibin Hu, Michael P A Davies, Michael W Marcus, Hans Brunnström, Jonas Manjer, Olle Melander, David C Muller, Kim Overvad, Antonia Trichopoulou, Rosario Tumino, Jennifer Doherty, Gary E Goodman, Angela Cox, Fiona Taylor, Penella Woll, Irene Brüske, Judith Manz, Thomas Muley, Angela Risch, Albert Rosenberger, Kjell Grankvist, Mikael Johansson, Frances Shepherd, Ming-Sound Tsao, Susanne M Arnold, Eric B Haura, Ciprian Bolca, Ivana Holcatova, Vladimir Janout, Milica Kontic, Jolanta Lissowska, Anush Mukeria, Simona Ognjanovic, Tadeusz M Orlowski, Ghislaine Scelo, Beata Swiatkowska, David Zaridze, Per Bakke, Vidar Skaug, Shanbeh Zienolddiny, Eric J Duell, Lesley M Butler, Woon-Puay Koh, Yu-Tang Gao, Richard Houlston, John McLaughlin, Victoria Stevens, David C Nickle, Ma'en Obeidat, Wim Timens, Bin Zhu, Lei Song, María Soler Artigas, Martin D Tobin, Louise V Wain, Fangyi Gu, Jinyoung Byun, Ahsan Kamal, Dakai Zhu, Rachel F Tyndale, Wei-Qi Wei, Stephen Chanock, Paul Brennan, Christopher I Amos 2018 Swedish Medical Group, Arnold Pavilion, Suite 200, Seattle, 98104, WA, USA.

Identification Of Susceptibility Pathways For The Role Of Chromosome 15q25.1 In Modifying Lung Cancer Risk., Xuemei Ji, Yohan Bossé, Maria Teresa Landi, Jiang Gui, Xiangjun Xiao, David Qian, Philippe Joubert, Maxime Lamontagne, Yafang Li, Ivan Gorlov, Mariella De Biasi, Younghun Han, Olga Gorlova, Rayjean J Hung, Xifeng Wu, James Mckay, Xuchen Zong, Robert Carreras-Torres, David C Christiani, Neil Caporaso, Mattias Johansson, Geoffrey Liu, Stig E Bojesen, Loic Le Marchand, Demetrios Albanes, Heike Bickeböller, Melinda C Aldrich, William S Bush, Adonina Tardon, Gad Rennert, Chu Chen, M Dawn Teare, John K Field, Lambertus A Kiemeney, Philip Lazarus, Aage Haugen, Stephen Lam, Matthew B Schabath, Angeline S Andrew, Hongbing Shen, Yun-Chul Hong, Jian-Min Yuan, Pier A Bertazzi, Angela C Pesatori, Yuanqing Ye, Nancy Diao, Li Su, Ruyang Zhang, Yonathan Brhane, Natasha Leighl, Jakob S Johansen, Anders Mellemgaard, Walid Saliba, Christopher Haiman, Lynne Wilkens, Ana Fernandez-Somoano, Guillermo Fernandez-Tardon, Erik H F M Van Der Heijden, Jin Hee Kim, Juncheng Dai, Zhibin Hu, Michael P A Davies, Michael W Marcus, Hans Brunnström, Jonas Manjer, Olle Melander, David C Muller, Kim Overvad, Antonia Trichopoulou, Rosario Tumino, Jennifer Doherty, Gary E Goodman, Angela Cox, Fiona Taylor, Penella Woll, Irene Brüske, Judith Manz, Thomas Muley, Angela Risch, Albert Rosenberger, Kjell Grankvist, Mikael Johansson, Frances Shepherd, Ming-Sound Tsao, Susanne M Arnold, Eric B Haura, Ciprian Bolca, Ivana Holcatova, Vladimir Janout, Milica Kontic, Jolanta Lissowska, Anush Mukeria, Simona Ognjanovic, Tadeusz M Orlowski, Ghislaine Scelo, Beata Swiatkowska, David Zaridze, Per Bakke, Vidar Skaug, Shanbeh Zienolddiny, Eric J Duell, Lesley M Butler, Woon-Puay Koh, Yu-Tang Gao, Richard Houlston, John Mclaughlin, Victoria Stevens, David C Nickle, Ma'en Obeidat, Wim Timens, Bin Zhu, Lei Song, María Soler Artigas, Martin D Tobin, Louise V Wain, Fangyi Gu, Jinyoung Byun, Ahsan Kamal, Dakai Zhu, Rachel F Tyndale, Wei-Qi Wei, Stephen Chanock, Paul Brennan, Christopher I Amos

Journal Articles and Abstracts

Genome-wide association studies (GWAS) identified the chromosome 15q25.1 locus as a leading susceptibility region for lung cancer. However, the pathogenic pathways, through which susceptibility SNPs within chromosome 15q25.1 affects lung cancer risk, have not been explored. We analyzed three cohorts with GWAS data consisting 42,901 individuals and lung expression quantitative trait loci (eQTL) data on 409 individuals to identify and validate the underlying pathways and to investigate the combined effect of genes from the identified susceptibility pathways. The KEGG neuroactive ligand receptor interaction pathway, two Reactome pathways, and 22 Gene Ontology terms were identified and replicated to ...


Il-16/Mir-125a Axis Controls Neutrophil Recruitment In Pristane-Induced Lung Inflammation, Siobhan Smith, Hardy Kornfeld, Caroline A. Jefferies 2018 Royal College of Surgeons in Ireland

Il-16/Mir-125a Axis Controls Neutrophil Recruitment In Pristane-Induced Lung Inflammation, Siobhan Smith, Hardy Kornfeld, Caroline A. Jefferies

Open Access Articles

Severe lung inflammation and alveolar hemorrhage can be life-threatening in systemic lupus erythematosus (SLE) patients if not treated early and aggressively. Neutrophil influx is the driver key of this pathology, but little is known regarding the molecular events regulating this recruitment. Here, we uncover a role for IL-16/mir-125a in this pathology and show not only that IL-16 is a target for miR-125a but that reduced miR-125a expression in SLE patients associates with lung involvement. Furthermore, in the pristane model of acute "SLE-like" lung inflammation and alveolar hemorrhage, we observed reduced pulmonary miR-125a and enhanced IL-16 expression. Neutrophil infiltration was ...


Amyotrophic Lateral Sclerosis Presenting As Chronic Cough, Marjorie Friedman, MD 2018 Thomas Jefferson University

Amyotrophic Lateral Sclerosis Presenting As Chronic Cough, Marjorie Friedman, Md

The Medicine Forum

INTRODUCTION

Amyotrophic Lateral Sclerosis (ALS) is a debilitating, uniformly fatal disease. While it most commonly presents with limb weakness, patients may also present with neurocognitive, respiratory, or bulbar symptoms. Despite its poor prognosis, an early diagnosis can save patients from unnecessary and expensive testing, lead to interventions that improve quality of life, and give patients and family time for advanced planning.1 This case highlights an unusual presentation of ALS.

KEY POINTS

  • Our patient presented with chronic cough and restrictive lung disease and after extensive workup was diagnosed with ALS.
  • Bulbar and respiratory symptoms are uncommon initial presentations of ALS ...


Use Of Venovenous Extracorporeal Membranous Oxygenation Following Iatrogenic Tracheal Rupture, Rajiv Kabadi, MD 2018 Thomas Jefferson University

Use Of Venovenous Extracorporeal Membranous Oxygenation Following Iatrogenic Tracheal Rupture, Rajiv Kabadi, Md

The Medicine Forum

INTRODUCTION

Iatrogenic tracheal rupture is a rare complication of endotracheal intubation and has a high risk of morbidity and mortality. Risk factors include female gender, short stature (height less than 160-cm), difficult airway anatomy, underlying connective tissue disorder, chronic obstructive pulmonary disease, use of a rigid stylet, inadequate intubation tube size, cuff over-inflation, emergent intubation and intubation performed by non-anesthesiologists. 1 Early recognition is important and diagnosis requires bronchoscopic confirmation.2,3 We describe a case where emergent venovenous extra-corporeal membrane oxygenation (VV-ECMO) was utilized in the management of tracheal rupture.

KEY POINTS

  • Tracheal rupture is an uncommon but severe ...


Congenitally Corrected Transposition Of The Great Arteries In A Septuagenarian From The Developing Country Of Pakistan, Hunaina Shahab, Salima Ashiqali, Mehnaz Atiq 2018 Aga Khan University

Congenitally Corrected Transposition Of The Great Arteries In A Septuagenarian From The Developing Country Of Pakistan, Hunaina Shahab, Salima Ashiqali, Mehnaz Atiq

Section of Pulmonary & Critical Care

Congenitally corrected transposition of the great arteries (CCTGA) is a rare congenital cardiac defect with atrioventricular and ventriculoarterial discordance which leads to heart failure and limits patients' lifespan. We report the case of a 70-year-old lady, from a poor province in Pakistan, who presented for the first time with palpitations and was diagnosed to have CCTGA. She had moderate pulmonic valve stenosis which was protective against heart failure. She had six children all born via spontaneous vertex delivery in her local village. This case exemplifies the fact that pulmonic stenosis is favourable for patients with CCTGA. In a country where ...


Erratum To Inequivalence Of Non-Aggressiveness In Clinically Diagnosed Lung Cancers And Overdiagnosis In Lung Cancer Screening Trials., Jerome M Reich, Jong S Kim 2018 Thoracic Oncology Program, Earle A Chiles Research Institute, Portland, OR, USA.

Erratum To Inequivalence Of Non-Aggressiveness In Clinically Diagnosed Lung Cancers And Overdiagnosis In Lung Cancer Screening Trials., Jerome M Reich, Jong S Kim

Journal Articles and Abstracts

[This corrects the article DOI: 10.21037/jtd.2018.01.164.].


A Rare Case Of Diffuse Alveolar Hemorrhage Secondary To Dabigatran Successfully Treated With Extracorporeal Membrane Oxygenation, C. Hutchinson, F. M. West, H. Hirose 2018 Thomas Jefferson University

A Rare Case Of Diffuse Alveolar Hemorrhage Secondary To Dabigatran Successfully Treated With Extracorporeal Membrane Oxygenation, C. Hutchinson, F. M. West, H. Hirose

Department of Medicine Posters

Introduction

Dabigatran, a direct thrombin inhibitor, is used for stroke risk reduction in non-valvular atrial fibrillation and for treatment and prevention of venous thromboembolism. Minor side effects include indigestion and stomach pain. Major life threatening bleeding occurs in up to 2% of patients and is largely attributed to gastrointestinal hemorrhage. Here, we describe a case of a dabigatran related diffuse alveolar hemorrhage (DAH) treated successfully with extracorporeal membrane oxygenation.


Alcohol Drives Oxidation-Dependent Desensitization Of Airway Cilia Motility Responsiveness, Michael Price 2018 University of Nebraska Medical Center

Alcohol Drives Oxidation-Dependent Desensitization Of Airway Cilia Motility Responsiveness, Michael Price

Theses & Dissertations

Alcohol abuse, which can impair clearance of pathogens and debris from the airway, is associated with an increase in complications and a higher mortality rate during the progression of pneumonia. With prolonged alcohol exposure, mucociliary clearance (MCC), which depends on the coordinated beating of cilia, is dysfunctional. Effective MCC relies on cAMP-dependent protein kinase (PKA) activation of ciliary beat frequency (CBF). PKA activation and stimulation of CBF are blunted with chronic exposure to alcohol. This phenomenon is known as alcohol-induced ciliary dysfunction (AICD). Previous studies have shown that concomitant feeding of mice with alcohol and antioxidants prevents AICD, suggesting a ...


Granulomatosis With Polyangiitis: A 17 Year Experience From A Tertiary Care Hospital In Pakistan, Omar Irfan, Haris Khan, Zarrar Khan, Alina Ashraf, Rimsha Ahmed, Javaid Khan, Ali Bin Sarwar Zubairi 2018 Aga Khan University

Granulomatosis With Polyangiitis: A 17 Year Experience From A Tertiary Care Hospital In Pakistan, Omar Irfan, Haris Khan, Zarrar Khan, Alina Ashraf, Rimsha Ahmed, Javaid Khan, Ali Bin Sarwar Zubairi

Section of Pulmonary & Critical Care

Objective: Granulomatosis with Polyangiitis (GPA) is an autoimmune, multi-system, small and medium vessel vasculitis with granulomatous inflammation. Aim of this study was to assess the clinical and radiological presentations of patients with GPA amongst the Pakistani population. It is a single centre retrospective single observation study.

Results: Study was conducted at the Aga Khan University Hospital, Karachi with records were reviewed from January 2000 to December 2017. Definitive diagnosis was made using a combination of serological anti-neutrophil cytoplasmic antibody (ANCA) testing along with the clinical and radiological presentation. A total of 51 patients met the diagnostic criteria in the time ...


Alt-803, An Il-15 Superagonist, In Combination With Nivolumab In Patients With Metastatic Non-Small Cell Lung Cancer: A Non-Randomised, Open-Label, Phase 1b Trial., John M Wrangle, Vamsidhar Velcheti, Manish R Patel, Elizabeth Garrett-Mayer, Elizabeth G Hill, James G Ravenel, Jeffrey S Miller, Mohammad Farhad, Kate Anderton, Kathryn Lindsey, Michele Taffaro-Neskey, Carol Sherman, Samantha Suriano, Marzena Swiderska-Syn, Amy Sion, Joni Harris, Andie R Edwards, Julie A Rytlewski, Catherine M Sanders, Erik C Yusko, Mark D Robinson, Carsten Krieg, William L Redmond, Jack O Egan, Peter R Rhode, Emily K Jeng, Amy D Rock, Hing C Wong, Mark P Rubinstein 2018 Earle A Chiles Research Institute, Portland, OR, USA.

Alt-803, An Il-15 Superagonist, In Combination With Nivolumab In Patients With Metastatic Non-Small Cell Lung Cancer: A Non-Randomised, Open-Label, Phase 1b Trial., John M Wrangle, Vamsidhar Velcheti, Manish R Patel, Elizabeth Garrett-Mayer, Elizabeth G Hill, James G Ravenel, Jeffrey S Miller, Mohammad Farhad, Kate Anderton, Kathryn Lindsey, Michele Taffaro-Neskey, Carol Sherman, Samantha Suriano, Marzena Swiderska-Syn, Amy Sion, Joni Harris, Andie R Edwards, Julie A Rytlewski, Catherine M Sanders, Erik C Yusko, Mark D Robinson, Carsten Krieg, William L Redmond, Jack O Egan, Peter R Rhode, Emily K Jeng, Amy D Rock, Hing C Wong, Mark P Rubinstein

Journal Articles and Abstracts

BACKGROUND: Immunotherapy with PD-1 or PD-L1 blockade fails to induce a response in about 80% of patients with unselected non-small cell lung cancer (NSCLC), and many of those who do initially respond then develop resistance to treatment. Agonists that target the shared interleukin-2 (IL-2) and IL-15Rβγ pathway have induced complete and durable responses in some cancers, but no studies have been done to assess the safety or efficacy of these agonists in combination with anti-PD-1 immunotherapy. We aimed to define the safety, tolerability, and activity of this drug combination in patients with NSCLC.

METHODS: In this non-randomised, open-label, phase 1b ...


Constrictive Pericarditis Presenting As Bilateral Pleural Effusion: A Report Of Two Cases, Manesh Kumar Gangwani, Salman B. Mahmood,, Fariha Hasan, Javaid Khan 2018 Aga Khan University

Constrictive Pericarditis Presenting As Bilateral Pleural Effusion: A Report Of Two Cases, Manesh Kumar Gangwani, Salman B. Mahmood,, Fariha Hasan, Javaid Khan

Section of Pulmonary & Critical Care

Constrictive pericarditis is a rare presentation. We need a very high index of clinical suspicion to diagnose the disease. It most commonly presents secondary to tuberculosis (TB) in the developing world and post-radiation therapy in the developed world. Classically, it presents with symptoms of heart failure and as pericardial thickening or calcification on imaging studies. In hospital settings, constrictive pericarditis is not usually considered as a differential in patients presenting with pleural effusion. According to the literature, associated pleural effusions in cases of constrictive pericarditis could be left-sided. Herein, we present two unusual presentations of cases with bilateral pleural effusions ...


Investigation Of Reactive Oxygen Species Production In The Rat Lung Using Optical Imaging, Nina Friedly 2018 Marquette University

Investigation Of Reactive Oxygen Species Production In The Rat Lung Using Optical Imaging, Nina Friedly

Master's Theses (2009 -)

Oxidative stress, the imbalance between production of oxidants or reactive oxygen species (ROS) and antioxidant activity, plays a key role in the pathogenesis of acute and chronic lung diseases. The objective of this thesis was to develop a robust protocol for measuring the rate of H2O2 production in isolated perfused rat lungs and to determine the cellular sources of that rate using Amplex Red (AR). For a given lung, AR (25 mM) along with horseradish peroxidase (5 U/ml) and ascorbate oxidase (1U/ml) were added to a perfusate reservoir that was recirculated through the lungs and sampled at 5 ...


Effect Of Study Design On Sample Size In Studies Intended To Evaluate Bioequivalence Of Inhaled Short-Acting Β-Agonist Formulations, Yaohui Zeng, Sachinkumar Singh, Kai Wang, Richard C. Ahrens 2018 University of Iowa

Effect Of Study Design On Sample Size In Studies Intended To Evaluate Bioequivalence Of Inhaled Short-Acting Β-Agonist Formulations, Yaohui Zeng, Sachinkumar Singh, Kai Wang, Richard C. Ahrens

Stead Family Department of Pediatrics Publications

Pharmacodynamic studies that use methacholine challenge to assess bioequivalence of generic and innovator albuterol formulations are generally designed per published Food and Drug Administration guidance, with 3 reference doses and 1 test dose (3-by-1 design). These studies are challenging and expensive to conduct, typically requiring large sample sizes. We proposed 14 modified study designs as alternatives to the Food and Drug Administration-recommended 3-by-1 design, hypothesizing that adding reference and/or test doses would reduce sample size and cost. We used Monte Carlo simulation to estimate sample size. Simulation inputs were selected based on published studies and our own experience with ...


Effect Of Study Design On Sample Size In Studies Intended To Evaluate Bioequivalence Of Inhaled Short-Acting Β-Agonist Formulations, Yaohui Zeng, Sachinkumar Singh, Kai Wang, Richard C. Ahrens 2018 University of Iowa

Effect Of Study Design On Sample Size In Studies Intended To Evaluate Bioequivalence Of Inhaled Short-Acting Β-Agonist Formulations, Yaohui Zeng, Sachinkumar Singh, Kai Wang, Richard C. Ahrens

Stead Family Department of Pediatrics Publications

Pharmacodynamic studies that use methacholine challenge to assess bioequivalence of generic and innovator albuterol formulations are generally designed per published Food and Drug Administration guidance, with 3 reference doses and 1 test dose (3-by-1 design). These studies are challenging and expensive to conduct, typically requiring large sample sizes. We proposed 14 modified study designs as alternatives to the Food and Drug Administration-recommended 3-by-1 design, hypothesizing that adding reference and/or test doses would reduce sample size and cost. We used Monte Carlo simulation to estimate sample size. Simulation inputs were selected based on published studies and our own experience with ...


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