Blogs
Explore the latest insights & trends in clinical research: Our blog is your go-to source for innovative perspectives & expertise
Latest Blogs
Role of the Institutional Review Boards (IRBs) at a Phase 1 CRO
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...
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...
Optimizing DMF and MMF Clinical Trials: Managing Flushing with Aspirin
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...
Developing Formulations for Phase 1 Clinical Trials
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...
Overcome Today’s Clinical Trial Enrollment Challenges
The efficient and timely enrollment of study participants is key to the success of clinical trials. However, the process of clinical trial recruitment has consistently been associated with challenges. For example, up to 85% of clinical trials face difficulties to...
Bioequivalence Vasoconstriction Assay Studies for Topical Corticosteroids
Understanding the Vasoconstriction Assay for Topical Corticosteroids In general, traditional pharmacokinetic (PK) endpoint studies, comparing the rate and extent of absorption of the drug estimated from the drug concentrations in a biological fluid, are a strong...
Bioanalytical Method Development: Isomers
Isomers are molecules that share the same molecular formula but have different structures. This means they contain the same number of atoms of each element, but these atoms are arranged differently. There are two main forms of isomerism: structural (or constitutional)...
The Role of Tmax in Bioequivalence Assessments: Past, Present, and Future
In the realm of drug bioequivalence assessments and Phase 1 clinical studies, the focus has traditionally been on parameters such as Cmax (maximum concentration) and AUC (area under the concentration-time curve), owing to their critical role in evaluating therapeutic...
Risk Management in Clinical Trials: The Sub-Investigators Role in Protecting Sponsor Investments
Clinical trials are a cornerstone of pharmaceutical development, entailing significant investment in terms of time, money, and resources. These early stage clinical trials are fraught with various risks ranging from clinical failures to regulatory issues, all of which...
Understanding Flip-Flop Pharmacokinetics: Challenges and Strategies in Drug Development
Pharmacokinetics (PK) modeling has been a useful tool thorough from pre-clinic to clinical (from Phase 1 to 3) in drug development, clinical research, and therapeutic optimization for centuries. The PK model used quantitative parameters to describe the complex...
Schedule a Discovery Call
You can unsubscribe at any time. For more details, please read our Privacy Policy.