Protocol Template
... objective is to assess the clinical efficacy as measured by the change in pulmonary function over the six month treatment period.” Other examples of objectives are maximum tolerated dose, proof of dose selection, or to assess the safety and pharmacokinetics. ...
... objective is to assess the clinical efficacy as measured by the change in pulmonary function over the six month treatment period.” Other examples of objectives are maximum tolerated dose, proof of dose selection, or to assess the safety and pharmacokinetics. ...
Curriculum Vitae - Chesapeake Research Group
... A randomized, double-blind, active- and placebo-controlled study of the analgesic efficacy and safety of repeated dosing of DIC075V relative to parenteral ketorolac and placebo in patients with acute moderate to severe post-surgical pain following mixed elective general orthopedic surgery ...
... A randomized, double-blind, active- and placebo-controlled study of the analgesic efficacy and safety of repeated dosing of DIC075V relative to parenteral ketorolac and placebo in patients with acute moderate to severe post-surgical pain following mixed elective general orthopedic surgery ...
Biomarker as Essential Part of Clinical Development
... develop in individual case (prognostic biomarker). In such context biomarkers indicate whether a drug will be effective in a specific patient and how the patient body will process it. Two studies involving prognostic and predictive iomarkers are discussed in this paper. A phase III study was perform ...
... develop in individual case (prognostic biomarker). In such context biomarkers indicate whether a drug will be effective in a specific patient and how the patient body will process it. Two studies involving prognostic and predictive iomarkers are discussed in this paper. A phase III study was perform ...
A critical review of Empirically Supported Treatments
... could be included in the ESTs list. Another methodological critical issue is that a treatment could be considered as EST only with the minimal standard of 2 supportive studies, “even if 50 other studies failed to find effects” (p.418, Herbert, 2003). “To make the EVT list, an approach need only demo ...
... could be included in the ESTs list. Another methodological critical issue is that a treatment could be considered as EST only with the minimal standard of 2 supportive studies, “even if 50 other studies failed to find effects” (p.418, Herbert, 2003). “To make the EVT list, an approach need only demo ...
Clinical effectiveness of cognitive therapy v. interpersonal
... out, so far the data collected in randomized comparisons of CT and IPT are insufficient to reliably decide whether the two therapies have differential effects on the BDI. More specifically, trial sequential analysis on the three existing studies examining the effects of individual CT and IPT for depre ...
... out, so far the data collected in randomized comparisons of CT and IPT are insufficient to reliably decide whether the two therapies have differential effects on the BDI. More specifically, trial sequential analysis on the three existing studies examining the effects of individual CT and IPT for depre ...
Rifaximin-Extended Intestinal Release Induces
... Boards/Ethics Committees at each center, and all patients gave written informed consent. The study was conducted according to the European Clinical Trials Directive (EudraCT number: 2007-001014-17) and registered with ClinicalTrials.gov (number: NCT00528073). ...
... Boards/Ethics Committees at each center, and all patients gave written informed consent. The study was conducted according to the European Clinical Trials Directive (EudraCT number: 2007-001014-17) and registered with ClinicalTrials.gov (number: NCT00528073). ...
London, 22 October 2009 * COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE
... Overtime, most patients develop chronic bacterial colonisation/infection of the airways. Bacterial colonisation occurs very early in the first few years of life. A typical persisting pathogen pattern in pulmonary tract (CFU/ml of Staphylococcus aureus (SA) and/or Pseudomonas aeruginosa (PA) strains) ...
... Overtime, most patients develop chronic bacterial colonisation/infection of the airways. Bacterial colonisation occurs very early in the first few years of life. A typical persisting pathogen pattern in pulmonary tract (CFU/ml of Staphylococcus aureus (SA) and/or Pseudomonas aeruginosa (PA) strains) ...
editor`s corner: what`s inside
... conference attracts a cavalcade of solutions providers – active and passive – each with their own take on the same basic package design: an insulated box with ice packs or some other temperature stabilizer wedged inside that is intended to keep the product at a predetermined temperature, for a prede ...
... conference attracts a cavalcade of solutions providers – active and passive – each with their own take on the same basic package design: an insulated box with ice packs or some other temperature stabilizer wedged inside that is intended to keep the product at a predetermined temperature, for a prede ...
Numbers-needed-to-treat analysis: an explanation using
... that individual. A number of authorities, including the National Institute for Health and Clinical Excellence (NICE), recommend that patients are actively involved in treatment decisions, but do not opine on how this can realistically be achieved. Nevertheless, presenting information on treatment in ...
... that individual. A number of authorities, including the National Institute for Health and Clinical Excellence (NICE), recommend that patients are actively involved in treatment decisions, but do not opine on how this can realistically be achieved. Nevertheless, presenting information on treatment in ...
Antibacterial class is not obviously important in outpatient pneumonia: a meta-analysis
... For the primary analysis, the intention-to-treat or modified intention-to-treat populations (those with CAP who had received at least one dose of study drug) were used. When the analysis was not clearly one of intention to treat, the clinically evaluable per protocol population were reviewed and inc ...
... For the primary analysis, the intention-to-treat or modified intention-to-treat populations (those with CAP who had received at least one dose of study drug) were used. When the analysis was not clearly one of intention to treat, the clinically evaluable per protocol population were reviewed and inc ...
Safety Summary of LGG Perspective of a Gastrointestinal Health
... primarily species of lactobacillus or bifidobacterium, appear to have health-promoting benefits when provided in conditions which have altered the normal human gastrointestinal flora. The science of probiotics is now focused on attempting to identify the most beneficial species and provide them in f ...
... primarily species of lactobacillus or bifidobacterium, appear to have health-promoting benefits when provided in conditions which have altered the normal human gastrointestinal flora. The science of probiotics is now focused on attempting to identify the most beneficial species and provide them in f ...
Obtaining Clinical Samples For Microbiology
... Clinical staff are to ensure that all tests are fully explained to patients so that they are able to give fully informed consent and this be documented in the patient’s notes. If a person has been assessed and deemed to lack capacity, that is, there is an impairment of, or disturbance in the functio ...
... Clinical staff are to ensure that all tests are fully explained to patients so that they are able to give fully informed consent and this be documented in the patient’s notes. If a person has been assessed and deemed to lack capacity, that is, there is an impairment of, or disturbance in the functio ...
NURS 135 - Great Basin College
... components of one of three ATI modules, Dosage and Calculations, at the ATI website. The difference between these three modules is the mathematical process that is used to determine correct dosages. Each student should do a quick review of each modality to determine which mathematical process is eas ...
... components of one of three ATI modules, Dosage and Calculations, at the ATI website. The difference between these three modules is the mathematical process that is used to determine correct dosages. Each student should do a quick review of each modality to determine which mathematical process is eas ...
01/27/2012 - The Medical University of South Carolina
... about the research project following completion of their participation in research. (Note that this usage, which occurs within the behavioral sciences, departs from standard English, in which debriefing is obtaining rather than imparting information.) ...
... about the research project following completion of their participation in research. (Note that this usage, which occurs within the behavioral sciences, departs from standard English, in which debriefing is obtaining rather than imparting information.) ...
Carvedilol was more effective than metoprolol tartrate for lowering
... Downloaded from http://ebm.bmj.com/ on May 14, 2017 - Published by group.bmj.com ...
... Downloaded from http://ebm.bmj.com/ on May 14, 2017 - Published by group.bmj.com ...
Cancer Pharmacoethnicity: Ethnic Differences in Susceptibility to the
... cyclophosphamide via conversion to dechloroethylcyclophosphamide (35). The importance of the CYP enzymes in anticancer pharmacokinetics has been well described (36, 37), and ethnic differences in the activity of several CYP enzymes are known (38, 39). One salient study of breast cancer patients show ...
... cyclophosphamide via conversion to dechloroethylcyclophosphamide (35). The importance of the CYP enzymes in anticancer pharmacokinetics has been well described (36, 37), and ethnic differences in the activity of several CYP enzymes are known (38, 39). One salient study of breast cancer patients show ...
the role of the drug regulatory agencies about the interaction
... conclusions are not really convincing. While the EMA published its two documents without attaching any related reference(4,5), the AEMPS based its new recommendation on incomplete sources such as the following(8): pharmacodynamic studies previously considered in its first report(7), two trials whose ...
... conclusions are not really convincing. While the EMA published its two documents without attaching any related reference(4,5), the AEMPS based its new recommendation on incomplete sources such as the following(8): pharmacodynamic studies previously considered in its first report(7), two trials whose ...
Indirect comparisons for single-arm trials or trials without
... first all–oral regimens vs. current standards of care, a head to head trial is not required to demonstrate superiority vs. the current standard of care ...
... first all–oral regimens vs. current standards of care, a head to head trial is not required to demonstrate superiority vs. the current standard of care ...
Content and Format of an Investigational New Drug (IND) Application
... doses, and, if possible, to gain early evidence on effectiveness. During Phase 1, sufficient information about the drug’s pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid, Phase 2 studies. The total number of subjects and p ...
... doses, and, if possible, to gain early evidence on effectiveness. During Phase 1, sufficient information about the drug’s pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid, Phase 2 studies. The total number of subjects and p ...
protocol synopsis
... 11.2 Protocol Adherence ............................................................................................................................................ 30 11.3 Study Amendments .............................................................................................................. ...
... 11.2 Protocol Adherence ............................................................................................................................................ 30 11.3 Study Amendments .............................................................................................................. ...
Alrex®
... Alrex® should not be used in cases of existing (suspected or confirmed) ocular viral, fungal, or mycobacterial infections. Alrex® may suppress the host response and thus increase the hazard of secondary ocular infections. The use of Alrex® in patients with a history of herpes simplex requires great ...
... Alrex® should not be used in cases of existing (suspected or confirmed) ocular viral, fungal, or mycobacterial infections. Alrex® may suppress the host response and thus increase the hazard of secondary ocular infections. The use of Alrex® in patients with a history of herpes simplex requires great ...
FDA Enforcement of Criminal Liability for Clinical
... 29. During pre-clinical testing, the sponsor must obtain toxicological and pharmacological information on the drugs. See 21 C.F.R. 312.23(a)(8); FDA, THE CDER HANDBOOK, supra note 28, at 5. In practice, however, most IND applicants only submit toxicology data. Interview with Peter Barton Hutt, Senio ...
... 29. During pre-clinical testing, the sponsor must obtain toxicological and pharmacological information on the drugs. See 21 C.F.R. 312.23(a)(8); FDA, THE CDER HANDBOOK, supra note 28, at 5. In practice, however, most IND applicants only submit toxicology data. Interview with Peter Barton Hutt, Senio ...
Endpoints in respiratory diseases
... A wide range of outcome measures or endpoints have been used in clinical trials to assess the effects of treatments in paediatric respiratory diseases. This can make difficult to compare treatment outcomes from different trials and also to understand whether new treatments offer a real clinical bene ...
... A wide range of outcome measures or endpoints have been used in clinical trials to assess the effects of treatments in paediatric respiratory diseases. This can make difficult to compare treatment outcomes from different trials and also to understand whether new treatments offer a real clinical bene ...
Adverse Event Reporting and IND Safety Reports
... Any AE considered serious or unanticipated in nature, degree or severity must be reported to the Sponsor’s representative within 24 hours of becoming aware of the adverse event (or per protocol). Per 21CFR312.64: “An investigator shall promptly report to the sponsor any adverse effect that may reaso ...
... Any AE considered serious or unanticipated in nature, degree or severity must be reported to the Sponsor’s representative within 24 hours of becoming aware of the adverse event (or per protocol). Per 21CFR312.64: “An investigator shall promptly report to the sponsor any adverse effect that may reaso ...
ceftin tablets and oral suspension
... CEFTIN for oral suspension is indicated for the treatment of pediatric patients aged 3 months to 12 years with mild-to-moderate acute bacterial maxillary sinusitis caused by susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae (non-β-lactamase–producing strains only). Limitation ...
... CEFTIN for oral suspension is indicated for the treatment of pediatric patients aged 3 months to 12 years with mild-to-moderate acute bacterial maxillary sinusitis caused by susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae (non-β-lactamase–producing strains only). Limitation ...