Pharma Digests
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
Critical Material Attributes (CMAs) of Excipients
When focusing solely CMAs of excipients, the same principles of API apply. These attributes influence the performance and manufacturability of the final drug product and are critical for achieving consistency in pharmaceutical formulations. Critical Material Attributes of Excipients Physical Properties Particle Size Distribution (PSD): Bulk Density and Tap Density: Specific ... Read More
Reference Standard (RS) in Bioequivalence Studies
Introduction In pharmaceutical development, a Reference Standard (RS), often referred to as a Reference Listed Drug (RLD) or comparator product, is a benchmark for evaluating the performance of generic drugs in bioequivalence (BE) studies. The RS ensures that generic drugs meet therapeutic equivalence standards, a critical step for regulatory approval. ... Read More
Alcohol Dose Dumping | A Critical Pharmaceutical Challenge
Introduction Alcohol dose dumping occurs when controlled-release formulations release their active ingredient rapidly in the presence of alcohol. This unintended release can lead to elevated drug levels, increasing risks of toxicity, side effects, or overdose. Mechanisms of Alcohol Dose Dumping Drugs at Risk Clinical Implications Preventive Measures Patient Strategies Regulatory ... 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
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