Introduction to Institutional Review Boards (IRBs) An Institutional Review Board (IRB) is an independent committee that reviews, approves, and monitors biomedical research that involves human participants. The primary purpose of an Institutional Review Board is to...
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Bioequivalence Studies: Designing an Effective Sampling Schedule
In pharmacokinetic analysis during the drug development processes, a well-structured sampling schedule is essential for accurately assessing the absorption, distribution, metabolism, and excretion (ADME) properties of a drug. However, missing data points remain...
Breaking Barriers: Exploring Rare Diseases and Orphan Drug Regulations in Canada
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...
Clinical Chemists in Early Phase & Bioequivalence Studies
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,...
How Proof of Mechanism Studies Can Advance Clinical Drug Development
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...
Using Bayesian Statistical Methods in Clinical Trials Across Different Phases
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...