Rare diseases, often referred to as orphan diseases, affect a small percentage of the population. Despite their rarity, these conditions collectively impact millions of lives. In Canada, as in many other countries, the regulation and development of treatments for rare...
BioPharma Services Inc. is a Contract Research Organization (CRO) that plays a pivotal role in drug development by providing outsourced research services on a contractual basis. These clinical trials are designed to evaluate the safety and tolerability of new drugs,...
Drug development is a complex and lengthy process associated with high costs. Bringing a new medicine to the clinical practice has been estimated to cost on average over US$ 1 billion and to last more than 12 years. Moreover, there is a high attrition rate in drug...
Bayesian statistical methods are revolutionizing the design and analysis of clinical trials across all phases by allowing continuous adaptation and the incorporation of prior knowledge. Unlike the frequentist approach, which typically relies on fixed sample sizes and...
Dimethyl fumarate (DMF) is a medication used primarily to treat relapsing forms of multiple sclerosis (MS). Monomethyl fumarate (MMF) is a derivative of fumaric acid that contains a single methyl group attached to the fumarate backbone. They belong to a class of drugs...
Phase 1 clinical trials, including first-in-human studies, bridge preclinical and clinical drug development by being the first stage in drug development programs during which a New Chemical Entity (NCE) or Investigational Medicinal Product (IMP) is evaluated in...
