Sentences with phrase «assess safety and efficacy»

Unfortunately, very few clinical trials are performed with children; thus, there is limited data with which to assess safety and efficacy.

[107] Establishing guidelines to assess safety and efficacy of botanical supplement products, the European Medicines Agency provided criteria for evaluating and grading the quality of clinical research in preparing monographs about herbal supplements.

She has experience in small molecule and large molecule development for both oncology and non-oncology indications and has a strong interest in developing alternative in vitro and in vivo methods to assess safety and efficacy outside of the traditional drug development paradigm.

A Phase 1/2 Study to Assess the Safety and Efficacy of Intratumoral IMO - 2125 in Combination with Ipilimumab or Pembrolizumab in Patients with Metastatic Melanoma

«So we bought the rights to the drug and started working with Professor Gabay to assess its safety and efficacy in a clinical trial,» explains Andrew Sleight, CEO of AB2 Bio Ltd., the Lake Geneva startup that has the World Wide license of the drug.

In broad terms, a regulatory writer assists in the production of the clinical documentation required by these national regulatory agencies when assessing the safety and efficacy of drugs.

The study assessed safety and efficacy of intracoronary autologous transplantation of bone marrow - derived human MSCs in patients with acute myocardial infarction.

The phase II part of a phase Ib / II study (ClinicalTrials.gov identifier: NCT02263508; MASTERKEY - 265)[24] assessing the safety and efficacy of T - VEC in combination with the PD - 1 — blocking antibody pembrolizumab in previously untreated, unresected stage IIIB / IV melanoma is evaluating confirmed ORR by irRECIST at week 24.

• Personalized drug safety can be addressed with patient - derived cells in Organ - Chips, enabling a patient - specific approach for assessing the safety and efficacy of new candidates while taking into account patient variability and the unique biology of individual patients.

Not exact matches

Follow - up data on safety and efficacy has been assessed at up to six years in women age 15 - 26 and the current team of investigators also looked at data on the large cohort of young people two years ago.

Patients are assessed for safety, immunogenicity, pharmacokinetics, biomarkers, and initial signals of efficacy.

Future work will continue to assess the safety and effectiveness of the procedure and efficacy of the technique with other mutations.

Their patients benefit by being closely monitored to assess the efficacy and safety of novel medications that are intended to treat their disease.

The study protocol calls for the children to be monitored for 15 years in order to assess the treatment's safety and efficacy.

A Phase 1/2 trial to assess safety, tolerability, and efficacy of the product in human subjects with diabetes, called STEP ONE, or Safety, Tolerability, and Efficacy of VC - 01 Combination Product in Type 1, was launched in September 2014, and the first implant was announced in Octobersafety, tolerability, and efficacy of the product in human subjects with diabetes, called STEP ONE, or Safety, Tolerability, and Efficacy of VC - 01 Combination Product in Type 1, was launched in September 2014, and the first implant was announced in Octobefficacy of the product in human subjects with diabetes, called STEP ONE, or Safety, Tolerability, and Efficacy of VC - 01 Combination Product in Type 1, was launched in September 2014, and the first implant was announced in OctoberSafety, Tolerability, and Efficacy of VC - 01 Combination Product in Type 1, was launched in September 2014, and the first implant was announced in OctobEfficacy of VC - 01 Combination Product in Type 1, was launched in September 2014, and the first implant was announced in October 2014.

A Phase III, Open Label, Randomized Study to Assess the Efficacy and Safety of Olaparib (Lynparza) versus Enzalutamide or Abiraterone Acetate in Men with Metastatic Castration - Resistant Prostate Cancer who have Failed Prior Treatment with a New Hormonal Agent and have Homologous Recombination Repair Gene Mutations.

The second study, FIREFISH, is aimed to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy in infants with Type I SMA.

«Human neurons — derived from reengineered skin cells — could help assess the efficacy and safety of these drugs, thereby reducing risks and resources associated with human trials.»

We carried out a multicentre single - arm phase II trial in women with AR - positive, estrogen, progesterone receptor and HER2 - negative (triple - negative) metastatic or inoperable locally advanced BC to assess the efficacy and safety of abiraterone acetate (AA) plus prednisone.

Safety and tolerability were evaluated, and pilot efficacy (AD Assessment Scale - Cognitive Subscale [ADAS - Cog], MRI, neuropsychological test battery [NTB], CSF tau, and Abeta42) was assessed in anti-AN1792 antibody responder patients (immunoglobulin G titer > or = 1:2,200).

Within the framework of TRANSVAC2, the HZI will offer access in the form of pre-clinical studies in the murine system to assess the immunogenicity, safety and efficacy of specific vaccine formulations.

So, regulators and drug developers are looking at ways to import data collected in early studies — which are used to initially assess drug safety and efficacy — into the Phase 3 studies that the FDA uses to determine whether drugs should make it onto the market.

Within the framework of TRANSVAC2, the HZI will offer access in the form of pre-clinical studies in the murine system to assess the immunogenicity, safety and efficacy of specific vaccine formulations containing a mucosal adjuvant.

An open - label pilot study to assess the efficacy and safety of virgin coconut oil in reducing visceral adiposity.

Kai Ming Liau et.al (2011) An Open - Label Pilot Study to Assess the Efficacy and Safety of Virgin Coconut Oil in Reducing Visceral Adiposity.

Charted and recorded information in client files.Tracked client movement on and off the unit by documenting times and destinations of clients.Checked facility for open windows, locked doors, malfunctioning smoke detectors and other safety hazards.Quickly responded to crisis situations when severe mental health and behavioral issues arose.Efficiently gathered information from families and social services agencies to inform development of treatment plans.Documented all patient information including service plans, treatment reports and progress notes.Collaborated closely with treatment team to appropriately coordinate client care services.Developed comprehensive treatment plans that focused on accurate diagnosis and behavioral treatment of problems.Consulted with psychiatrists about client medication changes, issues with medicine compliance and efficacy of medications.Organized treatment projects that focused on problem solving skills and creative thinking.Referred clients to other programs and community agencies to enhance treatment processes.Created and reviewed master treatment and discharge plans for each client.Guided clients in understanding illnesses and treatment plans.Developed appropriate policies for the identification of medically - related social and emotional needs of clients.Assisted clients in scheduling home visits and phone calls and monitored effectiveness of these activities.Evaluated patients for psychiatric services and psychotropic medications.Monitored patients prescribed psychotropic medications to assess the medications» effectiveness and side effects.Evaluated patients to determine potential need to transfer to specialized inpatient mental health facilities.Administered medication to patients presenting serious risk of danger to themselves and others.Conducted psychiatric evaluations and executed medication management for both inpatient and outpatient facilities.Led patients in individual, family, group and marital therapy sessions.Diagnosed mental health, emotional and substance abuse disorders.Recorded comprehensive patient histories and coordinated treatment plans with multi-disciplinary team members.Consulted with and developed appropriate treatment and rehabilitation plans for dually diagnosed patients.Referenced and used various therapy techniques, including psychodynamic, family systems, cognitive behavioral and lifespan integration psychotherapy.