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Articles 151 - 180 of 299
Full-Text Articles in Diseases
Assessment Of Pathways For The Introduction And Spread Of Mycobacterium Bovis In The United States, Katie Portacci, Jason Lombard, Lauren Abrahamsen, Eric Bush, Charles Fossler, Robert Harris, Kamina Johnson, Ryan S. Miller, Dianna Mitchell, Randy Pritchard, Steven Sweeney, Todd Weaver
Assessment Of Pathways For The Introduction And Spread Of Mycobacterium Bovis In The United States, Katie Portacci, Jason Lombard, Lauren Abrahamsen, Eric Bush, Charles Fossler, Robert Harris, Kamina Johnson, Ryan S. Miller, Dianna Mitchell, Randy Pritchard, Steven Sweeney, Todd Weaver
Zoonotics and Wildlife Disease: Publications
Bovine tuberculosis (TB) was responsible for more losses among U.S. farm animals in the early 20th century than all other infectious diseases combined. The Cooperative State-Federal Tuberculosis Eradication Program (established in 1917 and administered by APHIS, State animal health agencies, and U.S. livestock producers) has nearly eradicated bovine TB from the nation’s livestock population. However, despite the many accomplishments of the program, bovine TB remains a serious and costly disease of livestock in the United States. In 1992, VS conducted an assessment to identify pathways for the introduction and spread of bovine TB, in order to develop the most effective …
Diabetic Ketoacidosis Associated With Tacrolimus In Solid Organ Transplant Recipients, Muhammad Qamar Masood, Madiha Rabbani, Wasim Jafri, Manal Habib, Taimur Saleem
Diabetic Ketoacidosis Associated With Tacrolimus In Solid Organ Transplant Recipients, Muhammad Qamar Masood, Madiha Rabbani, Wasim Jafri, Manal Habib, Taimur Saleem
Section of Diabetes, Endocrinology and Metabolism
Diabetic ketoacidosis in patients receiving tacrolimus in the post-transplant setting is rare. We describe two such cases in solid-organ transplant recipients. The first patient, a 17-year-old male, presented with severe diabetic ketoacidosis and was managed with intravenous fluids and insulin infusion. He was a known case of Laurence-Moon-Bardet-Biedl syndrome and had received a renal transplant 2 years ago and was receiving tacrolimus since then. Although diabetic ketoacidosis resolved in 24 hours, large doses of subcutaneous insulin (upto 130 units per day) were needed to keep serum glucose within the normal range. Substitution of tacrolimus with cyclosporine obviated the need for …
Spurious Hyperkalaemia: An Insight, Khawaja Salman Zaki, Uzma Majid, Najmul Islam
Spurious Hyperkalaemia: An Insight, Khawaja Salman Zaki, Uzma Majid, Najmul Islam
Section of Diabetes, Endocrinology and Metabolism
Hyperkalaemia is a common electrolyte disorder with potentially lethal consequences and can lead to life-threatening cardiac dysrhythmias. Spurious hyperkalaemia, also known as pseudohyperkalaemia or factitious hyperkalaemiais, is also quite common in clinical practice and it's a source of avoidable emergency department visits or hospital admissions. We report a case in which alarming hyperkalaemia was found in a patient having Chronic Monomyelocytic Leukaemia on two different occasions, later diagnosed to be spurious.
Aneurysm Of Sinus Of Valsalva, Fateh Ali Tipoo Sultan, Nageeb Basir, Saulat H. Fatimi
Aneurysm Of Sinus Of Valsalva, Fateh Ali Tipoo Sultan, Nageeb Basir, Saulat H. Fatimi
Section of Cardiology
Aneurysm of sinus of Valsalva is a rare cardiac abnormality with congenital origin in most of the cases. If it is located in the right coronary sinus, it usually ruptures into a right heart chamber and frequently a ventricular septal defect (VSD) coexists with this condition. Early diagnosis and immediate surgical treatment can save the patient’s life in most cases. All the 3 cases reported in this series had aneurysm of right sinus of Valsalva with associated VSD and mild degree of aortic regurgitation (AR). Two of the cases ruptured aneurysm into the right ventricle. Trans-esophageal echocardiography was used to …
Negative Pressure Pulmonary Oedema: A Rare Complication Following General Anaesthesia, Zeeshan Waheed, Javaid Khan
Negative Pressure Pulmonary Oedema: A Rare Complication Following General Anaesthesia, Zeeshan Waheed, Javaid Khan
Section of Pulmonary & Critical Care
An important cause of pulmonary oedema is Negative Pressure Pulmonary Oedema (NPPE) which characteristically develops soon after extubation from an endo-tracheal intubation. In this case report we identified a case of previously healthy man who was intubated for General Anaesthesia for extraction of impacted molar tooth. Soon after extubation he developed severe respiratory distress. Immediate diagnosis of NPPE secondary to post extubation laryngospasm was made. He was promptly treated with 100 percent oxygen via CPAP (continuous positive airway pressure) mask and within an hour he markedly improved and subsequently became asymptomatic. NPPE is an important cause of morbidity and need …
Coming Down From Coming Out: Recharging The Activism Batteries, Kenneth P. Serbin
Coming Down From Coming Out: Recharging The Activism Batteries, Kenneth P. Serbin
At Risk for Huntington's Disease
No abstract provided.
‘Drug Hunters’ Bring Hope To Huntington’S Families, Kenneth P. Serbin
‘Drug Hunters’ Bring Hope To Huntington’S Families, Kenneth P. Serbin
At Risk for Huntington's Disease
No abstract provided.
Unmasking Gene Veritas: A Huntington's Disease Activist Goes Public, Kenneth P. Serbin
Unmasking Gene Veritas: A Huntington's Disease Activist Goes Public, Kenneth P. Serbin
At Risk for Huntington's Disease
No abstract provided.
A Survey Of Oxidative Paracatalytic Reactions Catalyzed By Enzymes That Generate Carbanionic Intermediates: Implications For Ros Production, Cancer Etiology, And Neurodegenerative Diseases, Victoria Bunik, John Schloss, John T. Pinto, Natalia Dudareva, Arthur J L Cooper
A Survey Of Oxidative Paracatalytic Reactions Catalyzed By Enzymes That Generate Carbanionic Intermediates: Implications For Ros Production, Cancer Etiology, And Neurodegenerative Diseases, Victoria Bunik, John Schloss, John T. Pinto, Natalia Dudareva, Arthur J L Cooper
NYMC Faculty Publications
Enzymes that generate carbanionic intermediates often catalyze paracatalytic reactions with O2 and other electrophiles not considered “normal” reactants. For example, pyridoxal 5′-phosphate (PLP)—containing pig kidney dopa decarboxylase oxidizes dopamine with molecular O2 to 3,4-dihydroxyphenylacetaldehyde at about 1% of the rate at which it catalyzes nonoxidative dopa decarboxylation. The mutant Y332F enzyme, however, catalyzes stoichiometric conversion of dopa to 3,4-dihydroxyphenylacetaldehyde, suggesting that even minor structural changes may alter or initiate paracatalytic reactions catalyzed by certain enzymes. Carbanions generated by several thiamine diphosphate (ThDP)—dependent enzymes react with different electrophiles, transforming some xenobiotics and endogenous compounds into potentially biologically hazardous products. The detrimental …
Causes Of Smoking In Pakistan: An Analysis Of Social Factors, Sobia Nizami, Zain A Sobani, Emmon Raza, Noor-Ul-Ain Baloch, Javaid Khan
Causes Of Smoking In Pakistan: An Analysis Of Social Factors, Sobia Nizami, Zain A Sobani, Emmon Raza, Noor-Ul-Ain Baloch, Javaid Khan
Section of Pulmonary & Critical Care
OBJECTIVE: To determine the factors contributing to the initiation and propagation of smoking in visitors to a major tertiary health center in Karachi, Pakistan.
METHODS: Seven major contributing factors to the initiation and propagation of smoking were presented to consenting study participants (n=170) in a questionnaire. Participants were then requested to use their experience and opinion to rate each of the given factors on a scale of 1 to 5 regarding its importance as a causative factor in the initiation and propagation of smoking. Results were analyzed using SPSSv16.0.
RESULTS: Preliminary analysis revealed occupational stress relief as the most important …
Feeling Like An Alien: Going Public About Huntington's, Kenneth P. Serbin
Feeling Like An Alien: Going Public About Huntington's, Kenneth P. Serbin
At Risk for Huntington's Disease
No abstract provided.
Unifying The Mathematical Modeling Of In Vivo And In Vitro Microdialysis, Peter M. Bungay, Rachita K. Sumbria, Ulrich Bickel
Unifying The Mathematical Modeling Of In Vivo And In Vitro Microdialysis, Peter M. Bungay, Rachita K. Sumbria, Ulrich Bickel
Pharmacy Faculty Articles and Research
A unifying approach is presented for developing mathematical models of microdialysis that are applicable to both in vitro and in vivo situations. Previous models for cylindrical probes have been limited by accommodating analyte diffusion through the surrounding medium in the radial direction only, i.e., perpendicular to the probe axis, or by incomplete incorporation of diffusion in the axial direction. Both radial and axial diffusion are included in the present work by employing two-dimensional finite element analysis. As in previous models, the nondimensional clearance modulus (Θ) represents the degree to which analyte clearance from the external medium influences diffusion through the …
Memories Of The Dna Car, Kenneth P. Serbin
Memories Of The Dna Car, Kenneth P. Serbin
At Risk for Huntington's Disease
No abstract provided.
Noncoronary Cardiac Abnormalities Are Associated With Coronary Artery Dilation And With Laboratory Inflammatory Markers In Acute Kawasaki Disease., Beth F. Printz, Lynn A. Sleeper, Jane W. Newburger, L Luann Minich, Timothy Bradley, Meryl S. Cohen, Deborah Frank, Jennifer S. Li, Renee Margossian, Girish S. Shirali, Masato Takahashi, Steven D. Colan, Pediatric Heart Network Investigators
Noncoronary Cardiac Abnormalities Are Associated With Coronary Artery Dilation And With Laboratory Inflammatory Markers In Acute Kawasaki Disease., Beth F. Printz, Lynn A. Sleeper, Jane W. Newburger, L Luann Minich, Timothy Bradley, Meryl S. Cohen, Deborah Frank, Jennifer S. Li, Renee Margossian, Girish S. Shirali, Masato Takahashi, Steven D. Colan, Pediatric Heart Network Investigators
Manuscripts, Articles, Book Chapters and Other Papers
OBJECTIVES: We explored the association of noncoronary cardiac abnormalities with coronary artery dilation and with laboratory inflammatory markers early after Kawasaki disease (KD) diagnosis.
BACKGROUND: Left ventricular (LV) dysfunction, mitral regurgitation (MR), and aortic root dilation occur early after diagnosis; their associations with coronary artery dilation and inflammatory markers have not been well-described.
METHODS: Centrally interpreted echocardiograms were obtained at KD diagnosis and 1 and 5 weeks after diagnosis on 198 subjects in the National Institutes of Health-sponsored Pediatric Heart Network KD pulsed steroid trial. Regression models were constructed to investigate the relationships among early LV dysfunction, MR, and aortic …
The Roles Of Conserved And Nonconserved Cysteinyl Residues In The Oligomerization And Function Of Mammalian Prestin, Benjamin Currall, Danielle Rossino, Heather Jensen Smith, Richard Hallworth
The Roles Of Conserved And Nonconserved Cysteinyl Residues In The Oligomerization And Function Of Mammalian Prestin, Benjamin Currall, Danielle Rossino, Heather Jensen Smith, Richard Hallworth
Journal Articles: Eppley Institute
The creation of several prestin knockout and knockin mouse lines has demonstrated the importance of the intrinsic outer hair cell membrane protein prestin to mammalian hearing. However, the structure of prestin remains largely unknown, with even its major features in dispute. Several studies have suggested that prestin forms homo-oligomers that may be stabilized by disulfide bonds. Our phylogenetic analysis of prestin sequences across chordate classes suggested that the cysteinyl residues could be divided into three groups, depending on the extent of their conservation between prestin orthologs and paralogs or homologs. An alanine scan functional analysis was performed of all nine …
Microrna-183 Family Expression In Hair Cell Development And Requirement Of Micrornas For Hair Cell Maintenance And Survival, Michael D. Weston, Marsha L. Pierce, Heather Jensen Smith, Bernd Fritzsch, Sonia Rocha-Sanchez, Kirk W. Beisel, Garrett A. Soukup
Microrna-183 Family Expression In Hair Cell Development And Requirement Of Micrornas For Hair Cell Maintenance And Survival, Michael D. Weston, Marsha L. Pierce, Heather Jensen Smith, Bernd Fritzsch, Sonia Rocha-Sanchez, Kirk W. Beisel, Garrett A. Soukup
Journal Articles: Eppley Institute
MicroRNAs (miRNAs) post-transcriptionally repress complementary target gene expression and can contribute to cell differentiation. The coordinate expression of miRNA-183 family members (miR-183, miR-96, and miR-182) has been demonstrated in sensory cells of the mouse inner ear and other vertebrate sensory organs. To further examine hair cell miRNA expression in the mouse inner ear, we have analyzed miR-183 family expression in wild type animals and various mutants with defects in neurosensory development. miR-183 family member expression follows neurosensory cell specification, exhibits longitudinal (basal-apical) gradients in maturating cochlear hair cells, and is maintained in sensory neurons and most hair cells into adulthood. …
The Role Of Streptococcus Mutans In The Formation Of Dental Caries: An Ecological Perspective, Jason Yeshaya Friedman
The Role Of Streptococcus Mutans In The Formation Of Dental Caries: An Ecological Perspective, Jason Yeshaya Friedman
The Science Journal of the Lander College of Arts and Sciences
The teeth are among the most distinctive and productive features of the human species. It is the longest lasting surface of the body and can be used in research studies many years after death. Yet, in the living individual, the integrity of the teeth is constantly assaulted by a microbial challenge so great that dental caries, or decay, ranks as one of the most widespread medical afflictions. According to studies, dental caries rank third in medical costs, behind only heart disease and cancer (Loesche 1996). This review will attempt to describe what is responsible for dental caries, namely a bacterium …
Talking To Children About Cancer, Talia Greenland
Talking To Children About Cancer, Talia Greenland
Graduate Student Independent Studies
Designed for children who have a close relationship with a young family member or peer with cancer. The purpose of this study is to suggest a general framework and a developmentally sound approach for talking to these children about cancer. Included is an original, illustrated children's book about a child with cancer, told from the viewpoint of the child's twin sibling.
Is Thrombolytic Therapy Safe When Used To Treat Elderly Patients?, Daniel Yaeger
Is Thrombolytic Therapy Safe When Used To Treat Elderly Patients?, Daniel Yaeger
The Science Journal of the Lander College of Arts and Sciences
Recently, research has been conducted to determine if thrombolytic therapy works to dissolve clots and if it is a safe treatment option. The specific purpose of this study is to determine if thrombolytic therapy is safe for use in the elderly. This study was conducted by reviewing the relevant literature that has been published from the time that research began to test the usefulness of thrombolytic therapy. Numerous journals were examined to ensure impartiality and emerge with an unbiased conclusion. The journals were discovered using PubMed article finder, using Google as a search engine, and by scrutinizing relevant references found …
Efficacy And Safety Of Once-Daily Aclidinium In Chronic Obstructive Pulmonary Disease, Paul W. Jones, Stephen I. Rennard, Alvar Agusti, Pascal Chanez, Helgo Magnussen, Leonardo Fabbri, James F. Donohue, Eric D. Bateman, Nicholas J. Gross, Rosa Lamarca, Cynthia Caracta, Esther Garcia Gil
Efficacy And Safety Of Once-Daily Aclidinium In Chronic Obstructive Pulmonary Disease, Paul W. Jones, Stephen I. Rennard, Alvar Agusti, Pascal Chanez, Helgo Magnussen, Leonardo Fabbri, James F. Donohue, Eric D. Bateman, Nicholas J. Gross, Rosa Lamarca, Cynthia Caracta, Esther Garcia Gil
Journal Articles: Pulmonary & Critical Care Med
BACKGROUND: The long-term efficacy and safety of aclidinium bromide, a novel, long-acting muscarinic antagonist, were investigated in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
METHODS: In two double-blind, 52-week studies, ACCLAIM/COPD I (n=843) and II (n=804), patients were randomised to inhaled aclidinium 200 μg or placebo once-daily. Patients were required to have a post-bronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity ratio of ≤70% and FEV1< 80% of the predicted value. The primary endpoint was trough FEV1 at 12 and 28 weeks. Secondary endpoints were health status measured by St George's Respiratory Questionnaire (SGRQ) and time to first moderate or severe COPD exacerbation.
RESULTS: At 12 and 28 weeks, aclidinium improved trough FEV1 versus placebo in ACCLAIM/COPD I (by 61 and 67 mL; both p< 0.001) and ACCLAIM/COPD II (by 63 and 59 mL; both p< 0.001). More patients had a SGRQ improvement≥4 units at 52 weeks with aclidinium versus placebo in ACCLAIM/COPD I (48.1% versus 39.5%; p=0.025) and ACCLAIM/COPD II (39.0% versus 32.8%; p=0.074). The time to first exacerbation was significantly delayed by aclidinium in ACCLAIM/COPD II (hazard ratio [HR] 0.7; 95% confidence interval [CI] 0.55 to 0.92; p=0.01), but not ACCLAIM/COPD I (HR 1.0; 95% CI 0.72 to 1.33; p=0.9). Adverse events were minor in both studies.
CONCLUSION: Aclidinium is effective and well tolerated …
Reduction Of Exacerbations By The Pde4 Inhibitor Roflumilast--The Importance Of Defining Different Subsets Of Patients With Copd, Stephen I. Rennard, Peter M.A. Calverley, Udo M. Goehring, Dirk Bredenbröker, Fernando J. Martinez
Reduction Of Exacerbations By The Pde4 Inhibitor Roflumilast--The Importance Of Defining Different Subsets Of Patients With Copd, Stephen I. Rennard, Peter M.A. Calverley, Udo M. Goehring, Dirk Bredenbröker, Fernando J. Martinez
Journal Articles: Pulmonary & Critical Care Med
BACKGROUND: As chronic obstructive pulmonary disease (COPD) is a heterogeneous disease it is unlikely that all patients will benefit equally from a given therapy. Roflumilast, an oral, once-daily phosphodiesterase 4 inhibitor, has been shown to improve lung function in moderate and severe COPD but its effect on exacerbations in unselected populations was inconclusive. This led to the question of whether a responsive subset existed that could be investigated further.
METHODS: The datasets of two previous replicate, randomized, double-blind, placebo-controlled, parallel-group studies (oral roflumilast 500 μg or placebo once daily for 52 weeks) that were inconclusive regarding exacerbations were combined in …
Differentiation Of Embryonic Stem Cells Into Fibroblast-Like Cells In Three-Dimensional Type I Collagen Gel Cultures, Shinsaku Togo, Tadashi Sato, Hisatoshi Sugiura, Xingqi Wang, Hesham Basma, Amy J. Nelson, Xiangde Liu, Tom W. Bargar, J. Graham Sharp, Stephen I. Rennard
Differentiation Of Embryonic Stem Cells Into Fibroblast-Like Cells In Three-Dimensional Type I Collagen Gel Cultures, Shinsaku Togo, Tadashi Sato, Hisatoshi Sugiura, Xingqi Wang, Hesham Basma, Amy J. Nelson, Xiangde Liu, Tom W. Bargar, J. Graham Sharp, Stephen I. Rennard
Journal Articles: Pulmonary & Critical Care Med
Fibroblasts are heterogeneous mesenchymal cells that play important roles in the production and maintenance of extracellular matrix. Although their heterogeneity is recognized, progenitor progeny relationships among fibroblasts and the factors that control fibroblast differentiation are poorly defined. The current study was designed to develop a reliable method that would permit in vitro differentiation of fibroblast-like cells from human and murine embryonic stem cells (ESCs). Undifferentiated ESCs were differentiated into embryoid bodies (EBs) with differentiation media. EBs were then cast into type I collagen gels and cultured for 21 d with basal media. The spindle-shaped cells that subsequently grew from the …
Detection Of Cardiac Myosin Heavy Chain-Α-Specific Cd4 Cells By Using Mhc Class Ii/IaK Tetramers In A/J Mice, Chandirasegara Massilamany, Arunakumar Gangaplara, Nora M. Chapman, Noel Rose, Jay Reddy
Detection Of Cardiac Myosin Heavy Chain-Α-Specific Cd4 Cells By Using Mhc Class Ii/IaK Tetramers In A/J Mice, Chandirasegara Massilamany, Arunakumar Gangaplara, Nora M. Chapman, Noel Rose, Jay Reddy
Jay Reddy Publications
A/J mice bearing the H-2 allele IAk are highly susceptible to autoimmune myocarditis induced with cardiac myosin heavy chain (Myhc)-α 334–352, whereas B10.A mice carrying a similar allele IAk are relatively resistant, suggesting that the generation of Myhc-α-reactive T cell repertoires is influenced by genetic background. To enumerate the precursor frequencies of Myhc-α-specific CD4 T cells, we sought to create IAk tetramers for Myhc-α 334–352. Tetramers were created using approaches that involve covalent tethering of individual peptide sequences or exogenous loading of peptides into empty IAk molecules by peptide-exchange reaction. Using ribonuclease 43– 56 tetramers as controls, we demonstrated that …
Going Viral, Judy Diamond
Going Viral, Judy Diamond
World of Viruses
Science education is developing new and innovative means of communication that compete directly with global media to reach the ‘YouTube Generation’. The truly interdisciplinary team of the SEPA-funded World of Viruses project is discovering how best to spread the word.
KEY COLLABORATORS
Judy Diamond, Professor, University of Nebraska State Museum
Charles Wood, Director, Nebraska Center for Virology
Moira Rankin, President, Soundprint Media Center, Inc
Carl Zimmer, Science writer and author of WoV book of essays, A Planet of Viruses
David Uttal, Cognitive science professor, Northwestern University
Benjamin Jee, Cognitive scientist, College of Holy Cross
Tom Floyd, Comic illustrator, Nebraska Educational …
Why Doesn’T A Pregnant Woman Reject Her Fetus, Lisa Merry
Why Doesn’T A Pregnant Woman Reject Her Fetus, Lisa Merry
3690: A Journal of First-Year Student Research Writing
Overview: Recurrent Pregnancy loss (RPL) occurs when a woman has three or more consecutive miscarriages; this phenomenon happens in about 1-3% of women. Why some women reject their unborn fetus and others carry theirs to term is still unclear. There are four main theories that exist regarding why some women reject their fetus and others do not: the maternal immune system might not be capable of responding to fetal antigens due to mechanisms that induce tolerance in responding maternal cells; a “barrier” may from between mother and fetus, preventing access of maternal immune cell to fetal antigens; fetal cells may …
Situation Assessment Of The Hiv Response Among Young People In Zambia, Sam Kalibala, Drosin Mulenga
Situation Assessment Of The Hiv Response Among Young People In Zambia, Sam Kalibala, Drosin Mulenga
HIV and AIDS
The main objective of this situational assessment is to compile and synthesize existing recent information on HIV and young people together with the current AIDS response for young people in Zambia—including programs, policies, and key partners—and to document gaps and challenges in the response. The assessment aims to further strengthen this response by all stakeholders including the Government of the Republic of Zambia, the UN, faith-based organizations, civil society organizations, donors, young people, and youth-led organizations. Recommendations include: amending and strengthening laws related to HIV programming for young people and involving them in design and implementation; offering health services, life …
Hiv Transmission Among Married Men And Women In Districts With High Out-Migration In India: Study Brief, Niranjan Saggurti, Bidhubhusan Mahapatra, Suvakanta N. Swain, Madhusudana Battala, Umesh Chawla, Alka Narang
Hiv Transmission Among Married Men And Women In Districts With High Out-Migration In India: Study Brief, Niranjan Saggurti, Bidhubhusan Mahapatra, Suvakanta N. Swain, Madhusudana Battala, Umesh Chawla, Alka Narang
HIV and AIDS
This brief describes a study examining the links between male out-migration and HIV transmission among married men and women and other mechanisms by which HIV is transmitted within marital relationships in districts with high out-migration.
Facilitating Regulatory Approval Of Multipurpose Prevention Technologies For Sexual And Reproductive Health, Martha Brady
Facilitating Regulatory Approval Of Multipurpose Prevention Technologies For Sexual And Reproductive Health, Martha Brady
HIV and AIDS
This brief describes multipurpose prevention technologies (MPTs) that address women's sexual and reproductive health (SRH) needs, and how to go about facilitating regulatory approval of this technology. It outlines a strategic framework to examine current regulatory guidance, as well a product development pathway to bring MPTs to market.
What Regulatory Guidance Exists For Multipurpose Prevention Technologies (Mpts)? A Review Of Key Guidance Documents And Their Applicability To Mpts, Martha Brady, Heeyoung Park
What Regulatory Guidance Exists For Multipurpose Prevention Technologies (Mpts)? A Review Of Key Guidance Documents And Their Applicability To Mpts, Martha Brady, Heeyoung Park
HIV and AIDS
This brief reviews regulatory guidance documents and how they may apply to multi-purpose technologies (MPTs). It examines guidance documents from the Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The brief concludes by anticipating increased interactions with US regulatory agencies in hopes of finding new regulatory pathways that address MPTs specifically.
Evaluation Of The Informed Consent Process For Male Circumcision Scale-Up In Swaziland, Barbara Friedland, Louis Apicella, Katie D. Schenk, Meredith Sheehy, Paul C. Hewett
Evaluation Of The Informed Consent Process For Male Circumcision Scale-Up In Swaziland, Barbara Friedland, Louis Apicella, Katie D. Schenk, Meredith Sheehy, Paul C. Hewett
HIV and AIDS
This report evaluates the informed consent process for male circumcision conducted through the Male Circumcision Partnership for Swaziland, led by Population Services International, in partnership with Jhpiego, Marie Stopes International, and the Population Council. The study assesses participants' comprehension of the circumcision process, the informed consent process, as well as the affect of male circumcision counseling on their experience.