Pharmacodynamics Sample Clauses

Pharmacodynamics. Levosimendan produces significant, dose-dependent increases in cardiac output, stroke volume and heart rate, and decreases in pulmonary capillary wedge pressure, mean blood pressure, mean pulmonary artery pressure, mean right atrial pressure and total peripheral resistance.30 The effect of levosimendan on hemodynamic variables was clearly evident already at the end of a 5-min bolus infusion.31 There is no sign of development of tolerance even with a prolonged infusion up to 48 hours.32 Due to the formation of the active metabolite, the hemodynamic effects are maintained several days after stopping levosimendan infusion.33 Compared with dobutamine, levosimendan produces a slightly greater increase in cardiac output and a profoundly greater decrease in pulmonary capillary wedge pressure.34, 35 In contrast to dobutamine, the hemodynamic effects are not attenuated with concomitant beta-blocker use.35 It has also been shown that at 48 hours after the start of infusion, a 24-hour infusion achieves superior hemodynamic effects over a 48-hour dobutamine infusion in patients with severe acute decompensated heart failure on beta-blockers.34 Several studies indicate that levosimendan produces a rapid and sustained decrease in natriuretic peptides. Xxxxxxxxx et al.33 found that a 24-hour levosimendan infusion induced a 40% decrease in plasma N-terminal atrial natriuretic peptide (NT-proANP) and N-terminal pro-BNP (NT-proBNP) levels and the treatment effect was estimated to last up to 16 and 12 days, respectively. The beneficial effects of levosimendan on hemodynamics and neurohormones are not associated with any significant increase in myocardial energy consumption, as evidenced using dynamic positron emission tomography (PET) in hospitalized patients with NYHA III-IV heart failure.36 Similarly, bolus doses of 8 µg/kg or 24 µg/kg did not increase myocardial oxygen consumption in postoperative patients, although cardiac function markedly improved.37 Levosimendan also possesses anti-stunning effects. This was shown in 24 patients with an acute myocardial infarction (AMI) who had undergone percutaneous transluminal coronary angioplasty (PTCA).38 A bolus dose of levosimendan improved the function of stunned myocardium, as evidenced by a substantial reduction in the number of hypokinetic segments in the left ventricular wall compared to placebo.
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Pharmacodynamics. Since neither one single dose nor one target concentration may be appropriate for all patients, researchers integrate the in vivo drug exposure and the in vitro susceptibility of pathogen against antimicrobial drugs, normally quantified as MIC, as a pharmacokinetic/pharmacodynamic (PK/PD) predictor for the in vivo antimicrobial efficacy. The relationship between the exposure to posaconazole and the corresponding antifungal response (PD) in relation to the pathogen susceptibility (MIC) has been verified in many preclinical studies.
Pharmacodynamics. The pharmacodynamics (PD) of H3K27 methylation in the pediatric population has not previously been studied, however the inhibition of H3K27me3 has been demonstrated to be necessary for tazemetostat efficacy in nonclinical models. Preliminary PD data from peripheral blood monocytes (PBMs) demonstrated a relationship between Cycle 1, Day 15 tazemetostat exposure and H3K27me3 levels, with consistent and significant post-dose reductions in H3K27me3 observed at the 900 and 1200 mg/m2 doses.
Pharmacodynamics. Plasma total Cu, ceruloplasmin, ceruloplasmin-bound Cu, and LBC will be assessed during the study. Blood samples will be collected as described in the SoA (Table 1) for plasma isolation as per the Laboratory Manual. The isolated plasma will be stored at -20°C before analysis. Plasma samples will be used for ICP-MS measurement of total Cu, ceruloplasmin, ceruloplasmin-bound Cu, and toxic copper as measured by LBC and/or NCC at the time points indicated in the SoA (Table 1).
Pharmacodynamics. In a series of in-vitro experiments, inflammatory challenges were performed on pbmCs and hirudinized whole blood from 4 healthy volunteers (who did not participate in the Phase 1 clinical trial). We assessed the effect of Cnm-au8 on in vitro toll-like receptor -9 (tlr9)-mediated cytokine release after stimulation with well-characterized tlr9 agonists. pbmCs and whole blood samples were incubated with a concentration range of Cnm-au8 for 6 to 24 hours. Subsequently, tlr9 ligands CpG (Cytosine phosphodiester and Guanine 58 measuring pharmacodynamics in early clinical drug studies in multiple sclerosis Chapter iv – gold nanopartiCles pharmaCokinetiCs in healthy volunteers 59 triphosphate) or ss-dna/lyovec were added to the culture, for an additional 3 to 24 hours. The response was quantified by measurement of cytokine release in culture supernatant (pan ifnα, il- 6, il-1β, tnfα). This in vitro study was performed to explore whether Cnm- au8 exerts anti-inflammatory effects. In that case, the tlr9 challenge would have been included as pharmacodynamic assay in the mad part of the clinical study. All pk parameters were calculated using non-compartmental analysis.Whole blood con- centrations below lloq were taken as 0 for the calculation of the descriptive statistics for whole blood gold concentrations at each sampling time. All pharmacokinetic calculations were done and individual subject whole blood concentration-time graphs were prepared using sas® for Windows® Version 9.4. Individual pharmacokinetic parameters for Cnm-au8 were summarized with descrip- tive statistics. Pharmacokinetic parameters such as the maximum observed plasma con- centration (Cmax), time to Cmax (tmax), the area under the plasma concentration versus time from time 0 to time of measurable plasma concentration after 24 hours (auC0-24h) and terminal-phase half-life (t½) were calculated using non-compartmental analyses and pharmacokinetic modelling. The study was performed between April 2015 and October 2016. Cohort 1 (single dose of 15 mg) was repeated due to a new batch of Cnm-au8 during the study. A total of 86 subjects participated in the phase 1 study of which 83 completed the study. Due to circumstances for cohort 5 (multiple dose, 15 mg) 10 subjects were enrolled (instead of the planned 12 subjects). Three subjects discontinued the study after dosing: one sub- ject retracted consent during the follow-up phase of the mad study, one subject of a mad cohort missed only the last follow-up ...
Pharmacodynamics. Sulglicotide is a sulphated glycopeptide chemically related to glycoproteins present in the gastric juice, accountable for the defense of the gastro-duodenal mucosa. Three hypotesis of mechanism of action: X cytoprotective action at gastro-duodenal level through increased biosynthesis of prostaglandins; X antagonism to gastric hyper-secretion, induced by most common mediators; X anti-peptic action by combination with pepsin and formation of a less active complex.

Related to Pharmacodynamics

  • Study An application for leave of absence for professional study must be supported by a written statement indicating what study or research is to be undertaken, or, if applicable, what subjects are to be studied and at what institutions.

  • Clinical 1.1 Provides comprehensive evidence based nursing care and individual case management to a specific group of patients/clients including assessment, intervention and evaluation. 1.2 Undertakes clinical shifts at the direction of senior staff and the Nursing Director including participation on the on-call/after-hours/weekend roster if required. 1.3 Responsible and accountable for patient safety and quality of care through planning, coordinating, performing, facilitating, and evaluating the delivery of patient care relating to a particular group of patients, clients or staff in the practice setting. 1.4 Monitors, reviews and reports upon the standard of nursing practice to ensure that colleagues are working within the scope of nursing practice, following appropriate clinical pathways, policies, procedures and adopting a risk management approach in patient care delivery. 1.5 Participates in xxxx rounds/case conferences as appropriate. 1.6 Educates patients/carers in post discharge management and organises discharge summaries/referrals to other services, as appropriate. 1.7 Supports and liaises with patients, carers, colleagues, medical, nursing, allied health, support staff, external agencies and the private sector to provide coordinated multidisciplinary care. 1.8 Completes clinical documentation and undertakes other administrative/management tasks as required. 1.9 Participates in departmental and other meetings as required to meet organisational and service objectives. 1.10 Develops and seeks to implement change utilising expert clinical knowledge through research and evidence based best practice. 1.11 Monitors and maintains availability of consumable stock. 1.12 Complies with and demonstrates a positive commitment to Regulations, Acts and Policies relevant to nursing including the Code of Ethics for Nurses in Australia, the Code of Conduct for Nurses in Australia, the National Competency Standards for the Registered Nurse and the Poisons Act 2014 and Medicines and Poisons Regulations 2016. 1.13 Promotes and participates in team building and decision making. 1.14 Responsible for the clinical supervision of nurses at Level 1 and/or Enrolled Nurses/ Assistants in Nursing under their supervision.

  • Diagnostic procedures to aid the Provider in determining required dental treatment.

  • Screening After you sign and date the consent document, you will begin screening. The purpose of the screening is to find out if you meet all of the requirements to take part in the study. Procedures that will be completed during the study (including screening) are described below. If you do not meet the requirements, you will not be able to take part in the study. The study investigator or study staff will explain why. As part of screening, you must complete all of the items listed below: • Give your race, age, gender, and ethnicity • Give your medical history o You must review and confirm the information in your medical history questionnaire • Give your drug, alcohol, and tobacco use history • Give your past and current medication and treatment history. This includes any over-the-counter or prescription drugs, such as vitamins, dietary supplements, or herbal supplements, taken in the past 28 days • Height and weight will be measured • Physical exam will be done • Electrocardiogram (ECG) will be collected. An ECG measures the electrical activity of the heart • You may be tested for COVID-19 o Blood tests for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C o Blood tests to see how your blood clots ▪ Fibrinogen ▪ PT/INR/aPTT o Blood tests for amylase and lipase (enzymes that help with digestion, Part B only) o Blood tests for a lipid (fats) panel (Part B only) ▪ Total cholesterol ▪ Triglycerides ▪ HDL ▪ Direct HDL o Blood tests to check your thyroid function (Part B and Part C only) ▪ TSH ▪ Free T4 o Urine to test for drugs of abuse (illegal and prescription) o Urine tests to check your albumin/ creatinine ratio o Females who have not had a period for at least 12 months in a row will have a blood hormone test to confirm they cannot have children • The study investigator may decide to do an alcohol breath test • The use of proper birth control will be reviewed (males only) • You will be asked “How do you feel?” HIV, hepatitis B, and hepatitis C will be tested at screening. If anyone is exposed to your blood during the study, you will have these tests done again. If you have a positive test, you cannot be in or remain in the study. HIV is the virus that causes acquired immunodeficiency syndrome (AIDS). If your HIV test is positive, you will be told about the results. It may take weeks or months after being infected with HIV for the test to be positive. The HIV test is not always right. Having certain infections or positive test results may have to be reported to the State Department of Health. This includes results for HIV, hepatitis, and other infections. If you have any questions about what information is required to be reported, please ask the study investigator or study staff. Although this testing is meant to be private, complete privacy cannot be guaranteed. For example, it is possible for a court of law to get health or study records without your permission.

  • Influenza Vaccine Upon recommendation of the Medical Officer of Health, all employees shall be required, on an annual basis to be vaccinated and or to take antiviral medication for influenza. If the costs of such medication are not covered by some other sources, the Employer will pay the cost for such medication. If the employee fails to take the required medication, she may be placed on an unpaid leave of absence during any influenza outbreak in the home until such time as the employee has been cleared by the public health or the Employer to return to the work environment. The only exception to this would be employees for whom taking the medication will result in the employee being physically ill to the extent that she cannot attend work. Upon written direction from the employee’s physician of such medical condition in consultation with the Employer’s physician, (if requested), the employee will be permitted to access their sick bank, if any, during any outbreak period. If there is a dispute between the physicians, the employee will be placed on unpaid leave. If the employee gets sick as a reaction to the drug and applies for WSIB the Employer will not oppose the application. If an employee is pregnant and her physician believes the pregnancy could be in jeopardy as a result of the influenza inoculation and/or the antiviral medication she shall be eligible for sick leave in circumstances where she is not allowed to attend at work as a result of an outbreak. This clause shall be interpreted in a manner consistent with the Ontario Human Rights Code.

  • Human Leukocyte Antigen Testing This plan covers human leukocyte antigen testing for A, B, and DR antigens once per member per lifetime to establish a member’s bone marrow transplantation donor suitability in accordance with R.I. General Law §27-20-36. The testing must be performed in a facility that is: • accredited by the American Association of Blood Banks or its successors; and • licensed under the Clinical Laboratory Improvement Act as it may be amended from time to time. At the time of testing, the person being tested must complete and sign an informed consent form that also authorizes the results of the test to be used for participation in the National Marrow Donor program.

  • Studies The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company or its subsidiaries that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus were and, if still pending, are being conducted in accordance in all material respects with all statutes, laws, rules and regulations, as applicable (including, without limitation, those administered by the FDA or by any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA). The descriptions of the results of such studies and tests that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus are accurate and complete in all material respects and fairly present the published data derived from such studies and tests, and each of the Company and its subsidiaries has no knowledge of other studies or tests the results of which are materially inconsistent with or otherwise call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, neither the Company nor its subsidiaries has received any notices or other correspondence from the FDA or any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA with respect to any ongoing clinical or pre-clinical studies or tests requiring the termination or suspension of such studies or tests. For the avoidance of doubt, the Company makes no representation or warranty that the results of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company will be sufficient to obtain governmental approval from the FDA or any foreign, state or local governmental body exercising comparable authority.

  • Study Population ‌ Infants who underwent creation of an enterostomy receiving postoperative care and awaiting enterostomy closure: to be assessed for eligibility: n = 201 to be assigned to the study: n = 106 to be analysed: n = 106 Duration of intervention per patient of the intervention group: 6 weeks between enterostomy creation and enterostomy closure Follow-up per patient: 3 months, 6 months and 12 months post enterostomy closure, following enterostomy closure (12-month follow-up only applicable for patients that are recruited early enough to complete this follow-up within the 48 month of overall study duration).

  • Infectious Diseases The Employer and the Union desire to arrest the spread of infectious diseases in the nursing home. To achieve this objective, the Joint Health and Safety Committee may review and offer input into infection control programs and protocols including surveillance, outbreak control, isolation, precautions, worker education and training, and personal protective equipment. The Employer will provide training and ongoing education in communicable disease recognition, use of personal protective equipment, decontamination of equipment, and disposal of hazardous waste.

  • Outcomes Secondary: Career pathway students will: have career goals designated on SEOP, earn concurrent college credit while in high school, achieve a state competency certificate and while completing high school graduation requirements.

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