Clinical Pharmacy
Prevention or Delay of Diabetes | Standards of Care in Diabetes 2024
In people with prediabetes, monitor for the development of type 2 diabetes at least annually; modify based on individual risk assessment. Refer adults with overweight or obesity at high risk of DM2, as seen in the Diabetes Prevention Program (DPP), to an intensive lifestyle behavior change program to achieve and ... Read More
Citrus Food with Substrate of Pgp and CYP3A4
Do we know that jabara is a Japanese citrus that is similar to yuzu and is consumed as an anti-allergic functional food in Japan and worldwide? We have previously discussed how grapefruit juice interacts with medications (drugs). A question arises: does jabara also interact with drugs? Guess what? It has ... Read More
Concepts of Elimination Rate and Clearance of Drugs
Have we come across a presenter who commented that the ‘clearance rate of a drug is high or low’? A question arises: Is clearance an elimination rate of a given drug? Some of us remain unclear regarding the concepts of elimination rate and clearance of drugs. Elimination rate is the ... Read More
Free Drug Hypothesis in Drug Discovery and Clinical Pharmacotherapy
Do we know why understanding the nuances associated with the free drug hypothesis is important for both drug discovery and clinical pharmacotherapy? Free drug hypothesis defines that (1) changes in drug action (pharmacodynamic or PD) is associated with changes in unbound drug concentration at target tissue (CuT), and (2) based ... Read More
Relation Between Renal clearance and Urine pH
Do we know why the renal clearance of some drugs (e.g. memantine) is sensitive to the change in urine pH? Memantine is a medication taken to slow the progression of moderate-to-severe Alzheimer’s disease. It is a basic (alkaline) and lipophilic (fat-liking) drug (pKa 10 and logP 3). Once memantine is ... Read More
Volume of Distribution (V)
Do we know that one of the most misunderstood pharmacokinetic (PK) parameters is volume of distribution (V)? This is especially exacerbated by the many terminologies of V. Let’s start with a simple yet important understanding that V is a proportionality factor that relates the amount of drug in the body ... Read More
Clinical Trial Terminologies | Part-2
KAPLAN-MEIER CURVE A graphical representation of survival probabilities over time in a clinical trial. HAZARD RATIO A measure comparing the risk of an event occurring in two groups over time. COX PROPORTIONAL HAZARDS MODEL A statistical method to explore the relationship between variables and time-to-event outcomes. DOSE-RANGING STUDY A study ... Read More
Clinical Trial Terminologies | Part-1
BLINDED ADJUDICATION A process where an independent committee reviews and classifies study outcomes without knowing which treatment group the participants belong to. SUBGROUP ANALYSIS An analysis conducted on specific subsets of participants (e.g., by age or gender) to explore differences in treatment effects. NON-INFERIORITY TRIAL A trial designed to demonstrate ... Read More
Food-Drug Interactions on Drug Safety & Efficacy
The FDA’s guidance Assessing the Effects of Food on Drugs in INDs and NDAs- Clinical Pharmacology Considerations, emphasizes the importance of Food-Effect (FE) studies in assessing how food influences the absorption, safety, and effectiveness of orally administered drugs during drug development. Here’s a breakdown of key takeaways: Why Food Effects ... Read More
Clinical Trials with Decentralized Elements
The U.S. Food and Drug Administration (FDA) issued final guidance titled “Conducting Clinical Trials with Decentralized Elements.” This guidance provides recommendations for sponsors, investigators, and other stakeholders on implementing decentralized elements in clinical trials. A decentralized clinical trial (DCT) is defined as a trial where trial-related activities occur outside traditional ... Read More