Relevant bibliographies by topics / Pharmaceutical clinical trials / Dissertations / Theses
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Dissertations / Theses on the topic 'Pharmaceutical clinical trials'

Author: Grafiati
Published: 4 June 2021
Last updated: 18 February 2022

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1

Barrios, Hemali. "Total Quality System Breakdowns in Outsourced Clinical Trials." ScholarWorks, 2016. https://scholarworks.waldenu.edu/dissertations/2019.

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Numerous deaths, tragedies, and underreported drug side effects occur in outsourced clinical trials. Total quality system breakdowns occur even though quality agreement contracts and quality management systems are used by pharmaceutical organizations. The purpose of this single case study was to explore strategies clinical quality assurance managers use to avoid breakdowns in quality with outsourced clinical trials in Asia-Pacific countries. The study included a purposeful sample of 15 clinical quality assurance managers from 1 pharmaceutical organization located in the Northeast region of the
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2

Ferrão, Ângela Filipa Machado. "Clinical research in a pharmaceutical industry." Master's thesis, Universidade de Aveiro, 2015. http://hdl.handle.net/10773/14880.

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Mestrado em Biomedicina Farmacêutica<br>This training report describes the knowledge and experience gained during the curricular internship at the Medical Affairs unit of the Research Department of Bluepharma Indústria S.A.. The main activities addressed are related with the conduction of phase I clinical trials by a sponsor, namely bioequivalence clinical trials. In this context, is described the main applicable regulations, the management process of a clinical trial and a reflection about the main challenges in the field. Furthermore, are outlined the activities related with the management
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3

Woodruffe-Peacock, Charlotte Anne. "Clinical trials on over-the-counter medicines in community pharmacies." Thesis, King's College London (University of London), 1998. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.299861.

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4

Egharevba, Terry. "Stakeholder perceptions towards conducting pharmaceutical industry-sponsored clinical trials in Sub-Saharan Africa." Thesis, University of Glasgow, 2017. http://theses.gla.ac.uk/8451/.

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Clinical trials are prospective studies in volunteers to test the safety and efficacy of a drug or intervention in a well-defined, controlled experiment. Pharmaceutical companies spend billions of dollars each year on clinical trials. Yet, despite the rising levels of chronic diseases and evidence suggesting that black patients may respond to treatments differently than their white counterparts, Sub-Saharan Africa is still represented in very few industry-sponsored trials. In addition to any immediate potential therapeutic benefit and the ability to grant patients greater access to drugs that
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5

Parsons, Laura B., and John B. Bossaer. "Differences in the Hyper-CVAD Regimen throughout Clinical Trials." Digital Commons @ East Tennessee State University, 2012. https://dc.etsu.edu/etsu-works/2355.

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6

Toth, Benjamin. "Clinical trials in British medicine 1858-1948, with special reference to the development of the randomised controlled trial." Thesis, University of Bristol, 1998. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.364843.

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7

Ma, Wing-yan. "Contract research organizations : performance and evaluation of services /." View the Table of Contents & Abstract, 2006. http://sunzi.lib.hku.hk/hkuto/record/B38030561.

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8

Salgueiro, Ana Cláudia Marques. "Curricular training in coordination of clinical trials in a clinical research unit." Master's thesis, Universidade de Aveiro, 2014. http://hdl.handle.net/10773/14285.

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Mestrado em Medicina Farmacêutica<br>This report describes several activities and projects developed in the context of a curricular training in a clinical research unit, Centro de Investigação Clínica (CIC), led by Professor Joaquim Ferreira. The CIC is one of the research groups of Instituto de Medicina Molecular (IMM) and it is also a group of the Centro Académico de Medicina de Lisboa (CAML) consortium. The principal area of training was the coordination of clinical trials and observational studies. Additionally, other research activities were conducted during the training such as, pharmac
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9

Lam, Wai-to Ivy, and 林慧桃. "Current good clinical practice (GCP) knowledge among investigators andemployees of pharmaceutical company." Thesis, The University of Hong Kong (Pokfulam, Hong Kong), 2004. http://hub.hku.hk/bib/B45010134.

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10

Wang, You-Gan. "Contributions to the theory of Gittins indices : with applications in pharmaceutical research and clinical trials." Thesis, University of Oxford, 1991. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.293423.

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11

Ferreira, Adriana Filipa da Silva. "Curricular training report: clinical trials coordination in neurology." Master's thesis, Universidade de Aveiro, 2015. http://hdl.handle.net/10773/21557.

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Mestrado em Biomedicina Farmacêutica<br>O presente relatório descreve as atividades desenvolvidas durante o estágio curricular como coordenadora de investigação clínica, que teve lugar na Unidade de Farmacologia Clínica do Instituto de Medicina Molecular e decorreu de Setembro de 2014 a Junho de 2015. A principal atividade desempenhada durante este estágio foi a coordenação de ensaios clínicos na área da neurologia, nomeadamente ensaios de fase II, III e IV. Foram desenvolvidas outras atividades, tais como gestão de dados clínicos, atividades de farmacovigilância e escrita científica e monito
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12

Tate, Wendy Rose. "Evaluation of Efficiency in the Activation and Accrual of Interventional Clinical Trials at Cancer Centers." Diss., The University of Arizona, 2016. http://hdl.handle.net/10150/612064.

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Background: Clinical trials represent a significant percentage of the time and cost to bring a drug through the development process and to Food and Drug Administration approval. Despite how critical these trials are to the drug development process, many studies are underpowered due to low accrual. This translates to valuable questions regarding the safety and effectiveness of new agents being left unanswered, requiring additional time and studies. A call for reform of the industry has been made by stakeholders in the clinical research enterprise; however, national change is slow. Thus site
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13

Correia, Márcia Sofia Barbosa. "Internship report in clinical studies coordination at IPO-Porto." Master's thesis, Universidade de Aveiro, 2014. http://hdl.handle.net/10773/12949.

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Mestrado em Biomedicina Farmacêutica<br>This report describes my activities as study coordinator (SC) intern, at the “Unidade de Investigação Clínica” (UIC) in the Oncology Portuguese Institute of Porto (IPOP). This training occurred during the second year of the Pharmaceutical Biomedicine Master at the University of Aveiro. My internship took place between 21st January, 2013 and 4th October, 2013 with the main objective to gain experience and expertise in oncology coordinating clinical trials. I present the state-of-the-art of clinical research with emphasis on current situation in Portugal a
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14

Sousa, Joana Cristina Mendes Cruz de. "Training report in clinical trials coordination at Blueclinical, LTD." Master's thesis, Universidade de Aveiro, 2016. http://hdl.handle.net/10773/17158.

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Mestrado em Biomedicina Farmacêutica<br>This report describes the activities performed as clinical research coordinator, during the internship of the Master in Pharmaceutical Medicine, at the University of Aveiro. The curricular internship took place at Blueclinical – particularly at Centro Hospitalar de Vila Nova de Gaia/Espinho, from 15th September 2015 to 15th April 2016. The report is divided into seven chapters. The training objectives are presented in the two chapter, and in the next chapter the host institutions are characterized. Then, in the four chapter it is presented the st
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15

Shi, Yun, and 施昀. "Escalation with overdose control for phase I drug-combination trials." Thesis, The University of Hong Kong (Pokfulam, Hong Kong), 2013. http://hub.hku.hk/bib/B49799733.

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The escalation with overdose control (EWOC) method is a popular modelbased dose finding design for phase I clinical trials. Dose finding for combined drugs has grown rapidly in oncology drug development. A two-dimensional EWOC design is proposed for dose finding with two agents in combination based on a four-parameter logistic regression model. During trial conduct, the posterior distribution of the maximum tolerated dose (MTD) combination is updated continuously in order to find the appropriate dose combination for each cohort of patients. The probability that the next dose combination excee
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16

Oliveira, Joana Pereira. "Curricular training report: clinical studies coordination in a clinical research organization vs an investigational site perspective." Master's thesis, Universidade de Aveiro, 2015. http://hdl.handle.net/10773/15780.

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Mestrado em Biomedicina Farmacêutica<br>This report describes my experience of nine months as a trainee of a CRO (Eurotrials, Scientific Consultants), as well as a trainee of a clinical research site (Clinical Academic Center – Braga, Association). This document describes the European framework about clinical research and the Portuguese situation compared to similar countries. The activities developed during this internship are also described. These activities are divided in two phases. The first one occurred in Eurotrials, Scientific Consultants, a CRO specialized in clinical research and s
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17

Turkoz, Ibrahim. "BLINDED EVALUATIONS OF EFFECT SIZES IN CLINICAL TRIALS: COMPARISONS BETWEEN BAYESIAN AND EM ANALYSES." Diss., Temple University Libraries, 2013. http://cdm16002.contentdm.oclc.org/cdm/ref/collection/p245801coll10/id/234528.

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Statistics<br>Ph.D.<br>Clinical trials are major and costly undertakings for researchers. Planning a clinical trial involves careful selection of the primary and secondary efficacy endpoints. The 2010 draft FDA guidance on adaptive designs acknowledges possible study design modifications, such as selection and/or order of secondary endpoints, in addition to sample size re-estimation. It is essential for the integrity of a double-blind clinical trial that individual treatment allocation of patients remains unknown. Methods have been proposed for re-estimating the sample size of clinical trials,
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18

Ma, Wing-yan, and 馬詠恩. "Contract research organizations: performance and evaluation of services." Thesis, The University of Hong Kong (Pokfulam, Hong Kong), 2006. http://hub.hku.hk/bib/B39724888.

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19

Georgievska, Liljana. "Curricular internship report in medical writing at Blueclinical, Portugal." Master's thesis, Universidade de Aveiro, 2015. http://hdl.handle.net/10773/15799.

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Mestrado em Biomedicina Farmacêutica<br>The contents of this report are a summary of the activities carried out during the 8-month internship as an Associate Medical Writer at Blueclinical Ltd, Matosinhos, Portugal. Mainly my activities were related to medical writing, particularly writing the clinical research protocols, clinical study reports, writing manuscript and preparing poster presentations. In addition to these activities, I also participated in performance of a clinical trial from beginning to end. During the period of its realization, I was able to familiarize myself with all the
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20

Moreira, Paula Cristina Leão. "Internship report on Blueclinical phase I unit." Master's thesis, Universidade de Aveiro, 2014. http://hdl.handle.net/10773/13413.

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Mestrado em Biomedicina Farmacêutica<br>Bioavailability/Bioequivalence clinical trials are a promising area in Pharmaceutical R&D and it is very interesting being involved in this field. During the internship, I practiced assistance activities to Bioavailability/Bioequivalence clinical trials and this was my target for intervention within Blueclinical during ten months. During this time I also had opportunity to exercise nursing research activities due to my previous training in the area. This report aims to describe the activities in which I was involved, the learning points and the experien
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21

Rodrigues, Raquel Filipa de Oliveira. "Relatório de estágio curricular numa unidade de investigação clínica." Master's thesis, Universidade de Aveiro, 2016. http://hdl.handle.net/10773/16575.

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Mestrado em Biomedicina Farmacêutica<br>This report presents the activities and projects developed during the curricular internship in a clinical research unit, the Laboratory of Clinical Pharmacology, part of the Institute of Molecular Medicine. The internship had a duration of 10 months, being that the most relevant activity was the coordination of clinical trials in the area of neurology. I also collaborated in medical writing activities, namely systematic reviews on cardiology, paediatrics and clinical pharmacology. I had also the opportunity to participate in the management of clinical d
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22

Simas, Ana Luísa Oliveira de. "Training report : clinical studies coordination in oncology." Master's thesis, Universidade de Aveiro, 2014. http://hdl.handle.net/10773/12966.

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Mestrado em Biomedicina Farmacêutica<br>This report describes a curricular training experience in Study Coordination, developed at Unidade de Investigação Clínica (Clinical Research Unit) of Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E. (Portuguese Oncology Institute-Porto), in the ambit of the Master in Pharmaceutical Medicine at University of Aveiro. This report describes the State of the Art in Pharmaceutical R&D Process in Europe, especially in Oncology, emphasising its current trends and stressing specificities of special and vulnerable populations, in the scope of t
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23

Clemson, Christine Moulton. "Development of a Multi-Site Phase II Clinical Trial of Valproic Acid for Retinitis Pigmentosa." eScholarship@UMMS, 2010. https://escholarship.umassmed.edu/gsbs_diss/470.

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The body of work presented here is a compendium of the multiple steps required for an investigator initiated trial of an existing medication (Valproic Acid- VPA) for a new indication (Retinitis Pigmentosa – RP). The chapters are listed in logical and chronological order of the process. In order to access patient records an expedited Institutional Review Board (IRB) application for retrospective chart review was submitted (Chapter 1). These records enabled the statistical analysis which not only laid the framework for the trial design, but also became the basis for two manuscripts (Chapter 2).
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24

In-Uba, Mariana José Manuel. "Curricular training report: 7 months as a study coordinator at Blueclinical LTD." Master's thesis, Universidade de Aveiro, 2015. http://hdl.handle.net/10773/15773.

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Mestrado em Biomedicina Farmacêutica<br>The present report describes in detail the activities undertaken under the coordination of clinical and observational studies during the curricular internship at Blueclinical Ltd., inserted in the Master of Pharmaceutical Biomedicine. Blueclinical Ltd.company operates in three different areas: R&D consultancy, management and coordination of trial centers, and a phase I unit. The curricular internship had the duration of seven months during which I was able to perform different tasks relating to coordination of clinical trials in Centro Hospitalar do Ba
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25

Jonvallen, Petra. "Testing Pills, Enacting Obesity : The work of localizing tools in a clinical trial." Doctoral thesis, Linköping : Univ. Department of Technology and Social Change, 2005. http://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-5132.

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26

Saikkonen, Patrik, and Kabir Khan. "Kliniska prövningars inverkan på läkemedelsföretagens aktiekurser." Thesis, Södertörns högskola, Institutionen för ekonomi och företagande, 2011. http://urn.kb.se/resolve?urn=urn:nbn:se:sh:diva-8854.

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Bakgrund: Läkemedelsbranschen är idag en av de mest reglerade branscherna på marknaden. Forskning och utveckling har en stor betydelse för läkemedelsföretagen. För att lansera ett läkemedel krävs det att företagen genomför kliniska prövningar, deras utfall kan mycket väl avgöra företagens framtid. Problemformulering: hur stor inverkan har de olika faserna inom produktutvecklingen på aktiekurserna för företag i läkemedelsbranschen. Syfte: Syftet med uppsatsen är att undersöka hur marknaden reagerar när läkemedel som är under utveckling går in i de tre olika kliniska faserna.Metod: Studien baser
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27

Escandon, Rafael Duncan. "Globalization of Clinical Research and Assessment of Global Access to Treatments Approved between 2006-2015." ScholarWorks, 2019. https://scholarworks.waldenu.edu/dissertations/7379.

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Globalization in clinical research and development has increased since the 1990s. Products approved in the United States (U.S.) and European Union (EU) include increasing numbers of research participants from low- and middle-income countries. The purposes of this quantitative correlational study were to investigate the lag time, or drug lag, between U.S. approval and the approval of selected drugs in all countries that hosted their pivotal clinical trials. The study population was limited to products approved first in the U.S. between 2006 and 2015. The health capability model and research for
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28

Junod, Valérie. "Clinical drug trials : studying the saftey and efficacy of new pharmaceuticals /." Bruxelles [u.a.] : Bruylant [u.a.], 2005. http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&doc_number=014759137&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA.

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Junod, Valérie. "Clinical drug trials : studying the safety and efficacy of new pharmaceuticals /." Genève ; Zurich ; Bâle : Genève : Bruxelles : Schulthess ; Faculté de droit ; Bruylant, 2005. http://aleph.unisg.ch/hsgscan/hm00153347.pdf.

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30

Almeida, Nuno Miguel Dias. "Curricular internship in a clinical research unit." Master's thesis, Universidade de Aveiro, 2016. http://hdl.handle.net/10773/17113.

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Mestrado em Biomedicina Farmacêutica<br>O presente relatório descreve em detalhe as tarefas e atividades desenvolvidas no contexto de um estágio curricular durante o segundo ano do Mestrado em Biomedicina Farmacêutica, da Universidade de Aveiro. Este estágio teve lugar na Unidade de Farmacologia Clínica do Professor Joaquim Ferreira, do Instituto de Medicina Molecular, de 14 de setembro de 2015 a 27 de junho de 2016. Esta experiência permitiu-me pôr em prática aquilo que aprendi no mestrado durante dez meses. Tive a oportunidade de trabalhar em três áreas diferentes da biomedicina farmacêutic
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31

Silva, Ricardo Daniel da Conceição. "The clinical research coordination: the coordination of a clinical trial in a rare disease." Master's thesis, Universidade de Aveiro, 2016. http://hdl.handle.net/10773/18773.

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Mestrado em Biomedicina Farmacêutica<br>This thesis aims to describe the professional activity of a clinical research coordinator. More specifically, it intends to demonstrate the importance of its role in the context of new drug development through the example of the coordination of a clinical trial in a rare disease in a hospital. For this purpose, the drug development process will be addressed and it will also be discussed the current pharmaceutical research and development paradigm. The Portuguese clinical trial reality and development of new drugs for rare diseases will also be sc
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32

Теленкова, И. В., та I. V. Telenkova. "Развитие фармацевтической индустрии как части глобальной производственной системы : магистерская диссертация". Master's thesis, б. и, 2020. http://hdl.handle.net/10995/98007.

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Актуальность работы обосновывается необходимостью: - выполнения законодательных документов, в т.ч. государственной программы РФ «Развитие фармацевтической и медицинской промышленности на период на 2013-2020 года», которая направлена на увеличение объема экспорта лекарственных средств до 75 млрд.руб. в 2020 году. - устранения следующего противоречия: с одной стороны, происходит смещение географии мировой фармацевтической индустрии в сторону развивающихся рынков; с другой стороны, фармацевтический рынок Россия в отличие от Китая, Индии и Кореи, находится в начальной стадии развития. Объект и
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Debonneuil, Edouard. "Analyses prospectives de mortalité : approches actuarielle et biomédicale." Thesis, Lyon, 2018. http://www.theses.fr/2018LYSE1096/document.

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La durée de vie humaine augmente dans le monde depuis quelques siècles. Cette augmentation a été plus importante que ne le prédisaient les spécialistes qui ont énoncé des limites. Malgré les incertitudes importantes sur l'avenir de la longévité, la biologie du vieillissement et ses applications semblent en passe de faire chuter les taux de mortalité aux grands âges, similairement à la chute des taux de mortalité infantile il y a 150 ans.L’industrie pharmaceutique prend conscience du potentiel des innovations biomédicales issues de la biologie du vieillissement, rachète des biotechs et développ
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Mauldin, Jo A. Seaman John Weldon. "Bayesian approaches to problems in drug safety and adaptive clinical trial designs." Waco, Tex. : Baylor University, 2008. http://hdl.handle.net/2104/5177.

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35

Lin, Molly. "Clinical Trial and Error: An Assessment of the Food and Drug Administration's Implementation of Breakthrough Therapy Designation." Scholarship @ Claremont, 2016. http://scholarship.claremont.edu/scripps_theses/823.

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This thesis explores the effectiveness of the Food and Drug Administration’s implementation of Breakthrough Therapy Designation (BTD), focusing on the low number of approval rates and repercussions of BTD for the development of new drugs for patients suffering serious life threatening illnesses. BTD, as an expedited review process, shows potential for improvement in its guidelines for necessary qualifications for BTD. Cutting costs, through a shortening in development time, and raising profits, through first mover status of new to market drugs, BTD is regarded by pharmaceutical executives as a
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36

Acharya, Milin R. "Clinical Pharmacology of MS-275, A Histone Deacetylase Inhibitor." VCU Scholars Compass, 2005. http://scholarscompass.vcu.edu/etd/832.

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The goal of this escalating single-dose phase I research study was to determine the safety, tolerability, pharmacokinetics, pharmacodynamics as well as in vitro metabolism and plasma protein binding of MS-275, a novel histone deacetylase inhibitor, in patients with solid tumors and lymphomas. A validated LC/MS assay was developed to quantitate MS-275 in plasma, human liver microsomes and urine. The pharmacokinetic (PK) evaluation was done using a non-compartmental approach. In-vitro plasma protein binding profile of MS-275 was characterized by a validated micro-equilibrium dialysis method. In
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37

El, Sanadi Caroline Elizabeth. "THE VALUE OF A FUNCTIONAL EXCIPIENT ADDITIVE TO HUMAN INSULIN THERAPIES: FROM MANUFACTURE TO HUMAN CLINICAL TRIAL." Case Western Reserve University School of Graduate Studies / OhioLINK, 2015. http://rave.ohiolink.edu/etdc/view?acc_num=case1450286879.

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Lakhani, Nehal Jagdish. "Evaluation of the Pharmacokinetic-Pharmacodynamic relationship, Metabolism and Plasma Protein Binding of the novel antitumor agent, 2-Methoxyestradiol (2ME2), following oral administration in patients with solid tumors." VCU Scholars Compass, 2005. http://scholarscompass.vcu.edu/etd/1381.

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The goal of this study was to determine safety, tolerability and pharmacokinetics of 2ME2 in patients with solid tumors and determine maximum tolerated dose (MTD). The following hypotheses were tested: 1) 2ME2 will be well tolerated in clinic when given orally and will have quantifiable effects on the ex vivo markers of angiogenesis and apoptosis; 2) 2ME2 will exhibit linear pharmacokinetics; 3) Plasma protein binding will be extensive and linear; 4) Sulfation will be the major metabolic pathway for 2ME2.This was a phase I dose escalation study. Twenty patients with refractory solid tumo
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Souley, Issoufou Mamane Sani. "Anthropologie d'un essai clinique : enjeux de santé globale autour d'un nouveau vaccin testé par un complexe humanitaro-scientifique." Thesis, Lyon, 2020. http://www.theses.fr/2020LYSEN035.

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En 2015, Epicentre, un centre de recherche épidémiologique crée en 1987 par l'ONG humanitaire Médecins Sans Frontières (MSF) se lance dans un essai clinique randomisé sur un nouveau vaccin contre les formes sévères de diarrhées des enfants de moins de cinq ans. Il est produit par le Serum Institute Of India Limited (entreprise pharmaceutique indienne). L'essai est conduit à Madarounfa, une localité rurale située dans le Sud du Niger. Cette thèse propose de discuter des dimensions globales et des enjeux locaux autour d'un vaccin, le Rotasiil que l'on peut définir comme « un vaccin africain » si
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Lamy, Ana Teresa Gonçalves. "Perceção das relações de cooperação em I&D em empresas farmacêuticas em Portugal : aplicação da janela de Johari." Master's thesis, Instituto Superior de Economia e Gestão, 2015. http://hdl.handle.net/10400.5/10523.

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Mestrado em Gestão e Estratégia Industrial<br>Cooperar é uma palavra que vem do latim cooperari e significa "ação de trabalhar ou laborar em grupo com outros para o mesmo objetivo". Nas organizações, devido à junção de diversas áreas do conhecimento, quer interna, quer externamente, hoje é necessário cooperar cada vez mais. No caso das empresas farmacêuticas, a cooperação para o desenvolvimento de um novo fármaco torna-se relevante permitindo que a empresa e parceiro obtenham vantagens dessa parceria. Porém, as organizações são constituídas por pessoas e a perceção destas acerca do que é uma r
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Fransén, Nelly. "Studies on a Novel Powder Formulation for Nasal Drug Delivery." Doctoral thesis, Uppsala universitet, Institutionen för farmaci, 2008. http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-9292.

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Nasal administration has potential for the treatment of indications requiring a fast onset of effect or for drugs with low oral bioavailability. Liquid nasal sprays are relatively common, but can be associated with suboptimal absorption from the nasal cavity; this thesis shows that nasal absorption can be significantly enhanced with a dry powder formulation. It was shown that interactive mixtures, consisting of fine drug particles adhered to the surface of mucoadhesive carrier particles, could be created in a particle size suitable for nasal administration. Sodium starch glycolate (SSG), a com
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42

Jadhav, Pravin R. "COMPARISON OF LONGITUDINAL AND CONVENTIONAL DATA ANALYSIS METHODS FOR ASSESSING EFFECTIVENESS." VCU Scholars Compass, 2006. http://scholarscompass.vcu.edu/etd_retro/139.

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Pharmaceutical drug development is a costly and time consuming process. Reportedly, it takes about 10-15 years and ~900 million dollars of investment to launch a new drug in the world market. Any measure that increases the power and also decreases uncertainty about that power also increases drug net present value. For some time now, it has been argued that judicious utilization of available data might lead to more efficient use of resources during drug development. Conventionally, assessment of effectiveness has been based on comparing change from baseline at some pre-specified time for the co
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Chang, Wei-Shun, and 張惟舜. "Correlates of the Quality of Pharmaceutical Clinical Trials Paper in Taiwan." Thesis, 2016. http://ndltd.ncl.edu.tw/handle/54694042763366478355.

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碩士<br>國立陽明大學<br>公共衛生研究所<br>104<br>Objective Consolidated standards of reporting trials is used to improve the quality of randomized clinical trials papers. This study will use the variables of the basic information published in randomized clinical trials papers and classify consolidated standards of reporting trials into four types from the latest 2010 version as index. To study factors associated with randomized clinical trials papers’ quality among Taiwan pharmaceutical randomized clinical trials literatures. Method Using research data from PubMed medical database, literatures on Taiwan phar
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Hsin, Hsu Hsiu, and 許秀鑫. "Legal Liability & Liability Insurance in Human Clinical Trials on Pharmaceutical Products." Thesis, 2010. http://ndltd.ncl.edu.tw/handle/53989364900494590523.

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碩士<br>東吳大學<br>法律學系<br>98<br>Clinical trials on pharmaceutical products, has been a very popular subject, particularly since 1995 the Executive Yuan to promote "Strengthening of the biotechnology industry program", furthermore, in 2003, the vision to develop Taiwan into an Asia-Pacific R & D, manufacturing and operations center. In 2004, conclusion of the Executive Yuan's Industrial Technology Strategy meeting, one of which is "to improve the clinical trial system." Hope to build Taiwan as the best partner of global biotech industry in terms of clinical research and clinical trials. After whic
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HSIEH, CHIA-YU, and 謝佳諭. "Human Clinical Trials on Pharmaceutical Products- Study of Review Procedure and Compensation Mechanism." Thesis, 2016. http://ndltd.ncl.edu.tw/handle/58816442393755528077.

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碩士<br>東吳大學<br>法律學系<br>104<br>Recently, human clinical trials has been valued gradually and there are not a few related lawsuit cases around the world. Due to the increase of rights of patients and medical arguments, this issue has become more and more noticeable. In the sphere of pharmaceutical products trials to human body, the benefits in which it involves are multiple, including the benefit of testers themselves and the public benefit to the whole society or to the academic research such as human dignity of testers, right of health and right of privacy…etc. Besides, such trials would make ‘
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Lu, Guan-Yu, and 呂灌育. "Analysis of Market Reactions to the Announcement of Clinical Trials in Biotech Pharmaceutical Industry." Thesis, 2015. http://ndltd.ncl.edu.tw/handle/74pr2k.

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碩士<br>國立交通大學<br>管理學院管理科學學程<br>103<br>This study was designed to investigate the phases of clinical trials of Taiwanese biotech drugmakers announcement on whether biotech pharmaceutical companies generate significant abnormal stock return. The sample period ranges from 2002 to 2015 in Taiwan listed Biotech Pharmaceuticals Corporations. The 228 announcement date in clinical trials are collected. This study shows that during clinical trial announcement date, there is a positive abnormal return rate of 1.1728%, and study also found that the first phase of clinical trials (Phase I ) have higher abn
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Yang, Hsiu-Wen, and 楊琇雯. "Influence of Personality Traits on willingness to Participate in Clinical Trials of Pharmaceutical Industry Employees." Thesis, 2014. http://ndltd.ncl.edu.tw/handle/70692383962852415181.

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碩士<br>臺北醫學大學<br>醫務管理學研究所<br>102<br>Before products launch, clinical trials for biotech products to market is the most important stage of pharmaceutical industry. According to clinical trial registration perform database show that Taiwan with a total time of ongoing clinical trials with thousands of pieces, and we need lots of participants. Multinational multi-center clinical trials in Taiwan prior to the implementation of the third phase, in recent years, due to their ability to enhance the pharmaceutical research and development, pre-clinical trials (phase I, II) and increase the recruitment
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Penz, Craig Christopher. "Baseline characteristics influencing placebo response in clinical trials of treatments for fragile X syndrome." Thesis, 2014. https://hdl.handle.net/2144/15220.

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Fragile X Syndrome (FXS) is a disorder caused by a congenital mutation of the FMR1 gene on the X chromosome. FXS is associated with moderate to severe intellectual disability and is one known cause of autism spectrum disorders. There are no approved medications to treat FXS symptoms. In 2013, Seaside Therapeutics completed two Phase 3 studies of an investigational medication, STX209, for treatment of social withdrawal in FXS. Efficacy results for these studies were not positive. Clinical trials of psychoactive drugs often fail to show a statistical difference from placebo controls and a
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Dias, José Augusto Aleixo. "Contribution of medical affairs to an efficient management in the pharmaceutical industry." Doctoral thesis, 2019. http://hdl.handle.net/10773/25719.

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During the last decade the pharmaceutical industry (PI) operations became far more complex due to several structural and organizational changes, new legislation and pharmacoeconomic constraints. The role of Medical Affairs (MA) has been increasingly important and the interactions between PI and healthcare professionals (HCP) are currently much more based on science, than in marketing or commercial arguments. This thesis provides an in-depth description of the MA function, maps key areas of activity, challenges processes and opportunities, based on the feedback collected from PI profes
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Hoerter, Jeanne. "To what extent does pharmaceutical company research in South Africa reflect the countries burden of disease?" Thesis, 2006. http://hdl.handle.net/10539/1870.

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Student Number : 0310496H - MPH research report - Faculty of Health Sciences<br>This study compares pharmaceutical company research on new medicines in South Africa with the country’s burden of disease and describes the process and criteria that companies use to set their research priorities. A quantitative survey of pharmaceutical companies shows that company research conducted from 2000 to 2003 is moderately associated with the country’s burden of disease estimates for 2000. The degree of association is dependent on which measures of company research and burden of disease are compared, and
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