caprisa 004 tenofovir gel trial
... CAPRISA 004 was designed according to the most rigorous international ethical standards to protect the wellbeing of the participants. CAPRISA 004 followed strict national and international procedures for monitoring and reporting, including regular reviews by an internal Protocol Safety Review Team ( ...
... CAPRISA 004 was designed according to the most rigorous international ethical standards to protect the wellbeing of the participants. CAPRISA 004 followed strict national and international procedures for monitoring and reporting, including regular reviews by an internal Protocol Safety Review Team ( ...
SANTEN RECEIVES FDA APPROVAL OF IQUIX
... fluoroquinolone active against a broad spectrum of Gram-positive and Gram-negative ocular pathogens. Levofloxacin's high solubility, at neutral pH, allows the solution to be formulated with a concentration of active drug (1.5%), three times higher than any other ophthalmic fluoroquinolone on the mar ...
... fluoroquinolone active against a broad spectrum of Gram-positive and Gram-negative ocular pathogens. Levofloxacin's high solubility, at neutral pH, allows the solution to be formulated with a concentration of active drug (1.5%), three times higher than any other ophthalmic fluoroquinolone on the mar ...
2 - Stephen F. Austin State University
... The student will 1. Relate concepts and principles of the arts, sciences, humanities, and nursing as a source for making nursing practice decisions with clients and families. 2. Demonstrate responsibility and accountability using consistent behavior patterns and professional communication. 3. Evalua ...
... The student will 1. Relate concepts and principles of the arts, sciences, humanities, and nursing as a source for making nursing practice decisions with clients and families. 2. Demonstrate responsibility and accountability using consistent behavior patterns and professional communication. 3. Evalua ...
THIRTY -SIXTH ANNUAL REPORT RESEARCH ADVISORY PANEL 2006
... importance of this study is that it offers a controlled, systematic study of a drug treatment protocol already in use across the United States. Both participants and research staff will be blinded to assignment oftreatment condition. The PROMETA™ pharmacotherapy is purported to have resulted in succ ...
... importance of this study is that it offers a controlled, systematic study of a drug treatment protocol already in use across the United States. Both participants and research staff will be blinded to assignment oftreatment condition. The PROMETA™ pharmacotherapy is purported to have resulted in succ ...
HYMAN, PHELPS 8 MCNAMARA, P. C.
... Biological Products” (draft guidance release for comment on March 13, 1997), and other pertinent guidelines available from the Agency. ...
... Biological Products” (draft guidance release for comment on March 13, 1997), and other pertinent guidelines available from the Agency. ...
Glossary Terms
... biomarker. A characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention. [Biomarker definitions working group] biostatistics. Branch of statistics applied to the analysis of ...
... biomarker. A characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention. [Biomarker definitions working group] biostatistics. Branch of statistics applied to the analysis of ...
Using SAS® for Modeling and Simulation in Drug Development – A Review and Assessment of Some Available Tools
... Modeling and simulation within the context of clinical trials has become an important tool used in addressing a variety of considerations and is now a widely used component for improving the efficiency of drug development. It is recognized as a powerful tool that can be used to make drug development ...
... Modeling and simulation within the context of clinical trials has become an important tool used in addressing a variety of considerations and is now a widely used component for improving the efficiency of drug development. It is recognized as a powerful tool that can be used to make drug development ...
Clinical Evaluation of Topical Application of Doxycycline 3% +
... Numerous host modulatory agents have been investigated in clinical trials. Non-steroidal anti-inflammatory drugs (NSAIDs), antimicrobial of doxycycline and or a combination of drugs have been successfully applied as an adjunct to non-surgical mechanical periodontal treatment [19,20]. Even so, the ex ...
... Numerous host modulatory agents have been investigated in clinical trials. Non-steroidal anti-inflammatory drugs (NSAIDs), antimicrobial of doxycycline and or a combination of drugs have been successfully applied as an adjunct to non-surgical mechanical periodontal treatment [19,20]. Even so, the ex ...
3.1 Serious Adverse Events
... might be reluctant fearing failure of this utilisation and associated costs. The recent strategy. Only a head to head second objective (DIVA) is to determine comparison of the several treatment whether sigmoidectomy with anastomosis options for perforated diverticulitis with and ileostomy or sigmoid ...
... might be reluctant fearing failure of this utilisation and associated costs. The recent strategy. Only a head to head second objective (DIVA) is to determine comparison of the several treatment whether sigmoidectomy with anastomosis options for perforated diverticulitis with and ileostomy or sigmoid ...
FAQS - Istituto Superiore di Sanità
... a specific characteristic of a sample of subjects in order to assess its real value (descriptive studies). Other studies are aimed at assessing the relationship between two variables within a sample of subjects (analytical studies). Therefore, differently from clinical trials, the events observed du ...
... a specific characteristic of a sample of subjects in order to assess its real value (descriptive studies). Other studies are aimed at assessing the relationship between two variables within a sample of subjects (analytical studies). Therefore, differently from clinical trials, the events observed du ...
A Randomized Trial of Rectal Indomethacin to Prevent Post
... occurred in 79 of 602 patients (13.1%). Of these events, 27 of 295 (9.2%) occurred in the indomethacin group and 52 of 307 (16.9%) occurred in the placebo group (P=0.005), corresponding to an absolute risk reduction of 7.7 percentage points (number needed to treat [NNT] to prevent one episode of pos ...
... occurred in 79 of 602 patients (13.1%). Of these events, 27 of 295 (9.2%) occurred in the indomethacin group and 52 of 307 (16.9%) occurred in the placebo group (P=0.005), corresponding to an absolute risk reduction of 7.7 percentage points (number needed to treat [NNT] to prevent one episode of pos ...
Reporting Bias in Clinical Trials Investigating the Efficacy of Second
... Different types of reporting biases can be present. Study publication bias occurs when studies with positive results are more likely to be published than studies with negative results.3 Outcome reporting bias involves publishing outcomes from a study that are “positive” (eg, statistically significan ...
... Different types of reporting biases can be present. Study publication bias occurs when studies with positive results are more likely to be published than studies with negative results.3 Outcome reporting bias involves publishing outcomes from a study that are “positive” (eg, statistically significan ...
How to translate new insights in MS into clinical practice ABSTRACT BOOK
... aspects of MS, and comment on how the findings of this research may affect clinical practice. The final session of the conference, Session VI, will focus on what is known about childhood MS and how best to approach the treatment of paediatric MS. Case studies will be presented, offering you the oppo ...
... aspects of MS, and comment on how the findings of this research may affect clinical practice. The final session of the conference, Session VI, will focus on what is known about childhood MS and how best to approach the treatment of paediatric MS. Case studies will be presented, offering you the oppo ...
CDISC Clinical Research Glossary
... Demographic, clinical, and other data collected for each participant at the beginning of the trial before the intervention is administered. NOTE: Randomized, controlled trials aim to compare groups of participants that differ only with respect to the intervention (treatment). Although proper random ...
... Demographic, clinical, and other data collected for each participant at the beginning of the trial before the intervention is administered. NOTE: Randomized, controlled trials aim to compare groups of participants that differ only with respect to the intervention (treatment). Although proper random ...
ELCC 2014 European Lung Cancer Conference Scientific Meeting
... Molecular testing for clinical practice Prof. Keith Kerr of the Aberdeen University Medical School, UK, provided some tips for success in biomarker testing. He said that one key is test anticipation. It is important to maximise tissue collection without causing the patient undue harm and to process ...
... Molecular testing for clinical practice Prof. Keith Kerr of the Aberdeen University Medical School, UK, provided some tips for success in biomarker testing. He said that one key is test anticipation. It is important to maximise tissue collection without causing the patient undue harm and to process ...
Phase 1 Trial Design: Is 3 + 3 the Best?
... of target events (eg, DLT) from the clinical data to assign patients to dose levels and determine the MTD or RP2D. Model-based designs use a statistical estimation of the target toxicity level by depicting the dose-toxicity relationship. The model is used to assign patients to dose levels and define ...
... of target events (eg, DLT) from the clinical data to assign patients to dose levels and determine the MTD or RP2D. Model-based designs use a statistical estimation of the target toxicity level by depicting the dose-toxicity relationship. The model is used to assign patients to dose levels and define ...
A 12-month, Open-Label, Multicenter Extension Trial of Orally
... postmortem examination of brains from narcoleptic patients.10 The possible therapeutic properties of sodium oxybate (gammahydroxybutyrate; GHB) in humans were first suggested 40 years ago.11 Since then, numerous studies have explored the potential clinical uses of sodium oxybate, including the treat ...
... postmortem examination of brains from narcoleptic patients.10 The possible therapeutic properties of sodium oxybate (gammahydroxybutyrate; GHB) in humans were first suggested 40 years ago.11 Since then, numerous studies have explored the potential clinical uses of sodium oxybate, including the treat ...
the LEAD (liraglutide effect and action in diabetes)-2
... demonstrated that GLP-1 exerts direct functional effects through both GLP-1 receptor dependent and independent pathways in the heart [9]. ...
... demonstrated that GLP-1 exerts direct functional effects through both GLP-1 receptor dependent and independent pathways in the heart [9]. ...
Croup - Nursing and midwifery in Western Australia
... Croup (also known as laryngotracheobronchitis) describes an acute clinical syndrome of hoarse voice, barking cough and stridor resulting from inflammation of the upper airway.3,7 Symptoms can fluctuate in severity depending on whether the child is distressed or c ...
... Croup (also known as laryngotracheobronchitis) describes an acute clinical syndrome of hoarse voice, barking cough and stridor resulting from inflammation of the upper airway.3,7 Symptoms can fluctuate in severity depending on whether the child is distressed or c ...
IIT - anzctr
... LABA 2 days before. During the washout period patients would be allowed to take SABA at 2 puffs qid. Once the washout period is complete, the patients would be tested for reproducibility for VOCs in exhaled air separated by 2 days. They would be able to use their shortacting beta2 agonists when nece ...
... LABA 2 days before. During the washout period patients would be allowed to take SABA at 2 puffs qid. Once the washout period is complete, the patients would be tested for reproducibility for VOCs in exhaled air separated by 2 days. They would be able to use their shortacting beta2 agonists when nece ...
INITIAL INVESTIGATIONAL NEW DRUG APPLICATION
... intended to be used in toxicological and clinical studies should be included. For injectable products, sterility and pyrogenicity tests, endotoxin levels and particulate matter should be included. Submitting a copy of the certificate of analysis of the clinical batch is also suggested. 4. The accept ...
... intended to be used in toxicological and clinical studies should be included. For injectable products, sterility and pyrogenicity tests, endotoxin levels and particulate matter should be included. Submitting a copy of the certificate of analysis of the clinical batch is also suggested. 4. The accept ...
Anticholinergics for Overactive Bladder
... Considerations for choosing and using anticholinergic drugs in OAB? • No ACs are more effective than oxybutynin 3,4 • Oxybutynin immediate release (IR) DITROPAN is the lowest cost AC & often suitable for initial therapy. HS dosing is suitable if night time is primary concern. It may also be useful “ ...
... Considerations for choosing and using anticholinergic drugs in OAB? • No ACs are more effective than oxybutynin 3,4 • Oxybutynin immediate release (IR) DITROPAN is the lowest cost AC & often suitable for initial therapy. HS dosing is suitable if night time is primary concern. It may also be useful “ ...
The Urgent Need Regenerating antibacterial drug
... and brought to market between 1983-1987, compared with the estimate that between only two and four new antibacterial agents will reach market between 2008-2012. It is by no means clear if even these will address the current clinical issues. The Urgent Need initiative was established in response to t ...
... and brought to market between 1983-1987, compared with the estimate that between only two and four new antibacterial agents will reach market between 2008-2012. It is by no means clear if even these will address the current clinical issues. The Urgent Need initiative was established in response to t ...
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... The Panel closed fifty-eight research studies during the year 2005. Twenty-one Independent studies were closed, of which eighteen were human studies and three were non-human studies. Thirty-four Multicenter Clinical Drug Trial studies were closed. Three Drug Abuse Treatment studies were closed .. At ...
... The Panel closed fifty-eight research studies during the year 2005. Twenty-one Independent studies were closed, of which eighteen were human studies and three were non-human studies. Thirty-four Multicenter Clinical Drug Trial studies were closed. Three Drug Abuse Treatment studies were closed .. At ...