Pharmacodynamics Clause Samples

The Pharmacodynamics clause defines how a drug or investigational product affects the body, focusing on its biochemical and physiological effects. In practice, this clause outlines the methods and parameters for measuring drug action, such as monitoring biomarkers, dose-response relationships, or therapeutic effects during a clinical trial. Its core function is to ensure that both parties understand how drug efficacy and safety will be evaluated, thereby supporting informed decision-making and regulatory compliance.
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.
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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).
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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.
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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.
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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. ▇▇▇▇▇▇▇▇▇ 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. 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 ...
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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 ▇▇▇▇ 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 The Health Plan must work with contracted providers to conduct interperiodic EPSDT screens on RIte Care and all ACA Adult Expansion Population members under age 21 (i.e. 19 and 20-year old under this Agreement) to identify health and developmental problems in conformance with ATTACHMENT ED to this Agreement. Additional screens should be provided as Medically Necessary. At a minimum, these screens must include: • A comprehensive health and developmental history, including health education, nutrition assessment, immunization history, and developmental assessment • Immunizations according to the Rhode Island EPSDT Periodicity Schedule • An unclothed physical examination • Laboratory tests including lead, TB, and newborn screenings as medically indicated • Vision testing • Hearing testing • Dental screening oral examination by PCP as part of a comprehensive examination required before age one (1) • All other medically indicated screening services • And provide EOHHS with a list of established CPT/HCPC codes used to identify all billable services included in the EPSDT schedule.

  • 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.