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I am a pharmacist by training and continued with a PhD in ClinicalPharmacology. However, my goal was all the time to work with drug development in the pharma industry, so I moved on and started that journey in 1992 when I took on a role as ClinicalResearch Manager at AstraHässle, a mid-size Swedish pharma company.
Altasciences Completes Successful Phase I Trial of Ischemix’ Novel Compound for Treatment of Traumatic Brain Injury (TBI) pmjackson Mon, 08/28/2023 - 14:04 Laval, Québec, August 30, 2023 – Altasciences is pleased to have completed a Phase I trial on Ischemix, Inc.’s The trial was performed at Altasciences’ clinical facility in Montréal.
These algorithms can swiftly navigate extensive databases of clinical trial information to pinpoint potential matches between patients and trials, considering various factors such as treatment protocols and geographical considerations.
Dr Nurbhai has more than 25 years of experience and a strong track record in the strategic and operational leadership of all phases of clinicalresearch and development at companies across Europe and the US. The Company is managed by a team with broad international, commercial and clinical-science experience.
A Modern Twist for the Gold Standard of ClinicalResearch The gold standard for clinicalresearch intended for regulatory approval is the randomized controlled trial that compares an investigational drug candidate to either a placebo, active control, or standard of care (SoC).
Deucravacitinib demonstrated efficacy no matter baseline characteristics, including weight , disease severity and former treatment with biologic or non-biologic therapies. Deucravacitinib also demonstrated durable efficacy in scalp psoriasis through 52 weeks of treatment (Poster Number: P1391).
Treatment with DFMO aka eflornithine, already a high-profile repurposing candidate in neuroblastoma, decreased intracellular pH in TAMCs and was associated with improved survival, more so when combined with immunotherapy or radiotherapy. Patients were randomised to treatment or observation groups and followed for six months.
Title Type Date Cleared by OIRA Legal Deadline None Notable FDA Comment Periods Closing in November and December FDA comment periods are typically open for 30-60 days, unless they are extended.
Redefining clinical trial design Precision medicine is revolutionising oncology by delivering therapies tailored to individual patients based on genetic and molecular factors. This approach aims to improve treatment efficacy (compared to cytotoxic chemotherapy), minimise toxicity, and necessitates an evolution in clinical trial methodologies.
Regulatory organizations like Health Canada, the International Council for Harmonisation (ICH), and the European Medicines Agency (EMA) have long emphasized the importance of including diverse populations in clinicalresearch. For example, elderly individuals are more prone to comorbidities, dementia, and functional decline.
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