Clinical Pharmacy
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
Hydrophilic and Hydrophobic Properties of Drug Substance
In pharmaceutical preparations, Hydrophobic and Hydrophilic properties play a crucial role in how drugs are formulated, delivered, and absorbed in the body. Hydrophobic Definition: Hydrophobic substances repel water and do not dissolve easily in it. They are often nonpolar molecules, like lipids or oils. Role in Pharmaceuticals Drug Solubility: Hydrophobic ... Read More
Prednisolone | Drug Digest
Prednisolone is a synthetic glucocorticoid, which works by mimicking the effects of cortisol, a naturally occurring hormone produced by the adrenal glands. It acts on the glucocorticoid receptor, affecting various cellular processes, including: Reducing inflammation by inhibiting the release of inflammatory mediators such as prostaglandins and leukotrienes. Suppressing the immune ... Read More
Pulmonary Embolism | A Life-Threatening Condition
As a professional pharmacist, it’s critical to shed light on Pulmonary Embolism (PE), a serious condition that can be life-threatening if not promptly treated. What is Pulmonary Embolism? PE occurs when a blood clot travels to the lungs, blocking one or more pulmonary arteries. This blockage can severely impair lung ... Read More
FDA Clinical Study Requirements for IND
Clinical study requirements for an Investigational New Drug (IND) application are designed to ensure the safety and efficacy of the investigational drug during human trials. Here are the key aspects and requirements: Clinical Study Protocol A detailed clinical study protocol must be included in the IND application. This protocol should ... Read More
Diabetes and Foot Care Recommendations
American Diabetes Association (ADA) Standards of Care 2024: 1. Perform a comprehensive foot evaluation at least annually to identify risk factors for ulcers and amputations. 2. The examination should include inspection of the skin, assessment of foot deformities, neurological assessment (10-g monofilament testing with at least one other assessment: pinprick, ... Read More
Insulin Therapy in Type 2 Diabetes
ADA Standards of Care 2024 1. Many adults with type 2 diabetes eventually require and benefit from insulin therapy. The progressive nature of type 2 diabetes should be regularly and objectively explained to individuals with diabetes, and clinicians should avoid using insulin as a threat or describing it as a ... Read More
LYRICA (Pregabalin) | Drug Digest
LYRICA (pregabalin) has been Pfizer’s flagship blockbuster brand for many years due to the fact that it has been approved in multiple indications. It has also been the highest-selling neurology brand for several years. As such, the company has tried using aggressive strategies to extend the brand’s lifecycle in order ... Read More