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Establishing Effective Adaptive Trial Designs for Oncology in Multi-Regional Studies

Conversations in Drug Development Trends

However, implementing adaptive trial designs within MRCTs requires careful consideration of international regulatory standards to optimize patient outcomes and resource efficiency. The International Council for Harmonisation of Technical Pharmaceuticals for Human Use provides guidelines, but local adaptations and interpretations still vary.

Trials 80
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Where is the promise for plant-based medicines? Part 1: Cannabis  

Drug Discovery World

The situation in Europe follows a similar narrative of “more” – more research, more trials, and more results are needed for medical cannabis to reach its full potential. Jazz Pharmaceuticals has supplied the cannabidiol for the trials at no cost.

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Four Pain Models Altasciences Uses to Assess Treatments During Clinical Trials

Alta Sciences

COMMONLY USED PAIN MODELS As pain models continue to expand, there are still many tried and tested ways to achieve the most accurate results possible, such as pain stimulation, pharmacodynamics (PD), and pharmacokinetics (PK) for early phase analgesic trials. WHY IS PAIN RESEARCH SO IMPORTANT? WHAT IS PAIN AWARENESS MONTH? in 2001.

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What Does a CRO Actually Do?

Vial

These roles include project managers, research assistants, site contract managers, quality managers, clinical research associates, clinical trial assistants, regulatory affairs managers, heads of clinical operations, data managers, statistical programmers, and biostatisticians.

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Novo Nordisk: positivity for haemophilia treatment  

Drug Discovery World

Earlier this year, pharmaceutical company Novo Nordisk announced positive results from Phase I & II clinical trials investigating its antibody treatment for haemophilia A. . Abstract presented at International Society of Thrombosis and Haemostasis (ISTH) 2022. 3 Windyga J, Chowdary P, Lopez-Jaime F, et al.

Treatment 130
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Poxel Announces Additional Positive Phase 2a Results, and Phase 2b Plan for PXL770, an Oral First-in-Class AMPK Activator, in NASH

The Pharma Data

The Phase 2b trial will also evaluate efficacy on other histology endpoints (fibrosis), assessment of metabolic and non-metabolic parameters, pharmacokinetic assessment as well as safety and tolerability. Harrison, MD, Director, Summit Clinical Research. The Phase 2b trial is expected to begin during the second half of 2021.

Trials 52
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Bristol Myers Squibb Announces Interim Results from Long-Term Study Reinforcing Efficacy and Safety Profile of Zeposia (ozanimod) in Patients with Relapsing Forms of Multiple Sclerosis

The Pharma Data

study investigator and Professor of Clinical Neurology, University of California San Francisco (UCSF) Weill Institute for Neurosciences and clinical research director, UCSF MS Center. Inhibition of drug transporter breast cancer resistance protein has no effect on the pharmacokinetics of major active metabolites of ozanimod.