Author Archives: itembalabantu

CGMs are wearable devices that continuously monitor glucose levels in people with diabetes. They are often used by people with type 1 diabetes who require insulin therapy, but they are also increasingly being used by people with type 2 diabetes. Here are some key trends and factors driving growth in the CGM market: Some keyContinue reading “The continuous glucose monitor (CGM) market”

Firstly, CGMs are becoming increasingly popular in Korea due to the rising incidence of diabetes. According to the International Diabetes Federation, there were an estimated 5.8 million people with diabetes in Korea in 2021, accounting for approximately 10% of the adult population. As a result, there is a growing need for diabetes management tools, includingContinue reading “The continuous glucose monitor (CGM) market in Korea”

The International Conference on Harmonisation (ICH) E6 Guideline for Good Clinical Practice (GCP) provides guidance on the conduct of clinical trials. The guideline outlines key principles and processes that should be followed in order to ensure the safety and well-being of trial participants, and to ensure the validity and reliability of trial data. The followingContinue reading “Clinical trial conduct described in the ICH E6”

Blinding, also known as masking, is a key concept in clinical trials. It refers to the process of concealing information about the interventions assigned to participants in the trial, in order to reduce bias in the assessment of the treatment effect. The aim of blinding is to ensure that the assessment of the outcomes isContinue reading “Blinding in clinical trials”

In a clinical trial, the term “cohort” refers to a subgroup of participants who share common characteristics or have been exposed to similar interventions. For example, in a clinical trial comparing the efficacy of two different drugs, one cohort of participants may receive drug A while another cohort receives drug B. The term “arm” isContinue reading “What is the difference between cohorts and arms in clinical trials?”

In a clinical trial, adequate power refers to the probability that a trial will be able to detect a significant difference between the treatment and control groups if such a difference exists. The power of a trial is determined by several factors, including the sample size, the magnitude of the treatment effect, the variability ofContinue reading “In clinical trials what is adequate power and how can we assume it?”

ICH E6 (R2) is a set of guidelines developed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) for the conduct of clinical trials. The guidelines were updated in November 2016 and are commonly referred to as ICH E6 (R2). The guidelines provide recommendations for the design, conduct, andContinue reading “ICH E6”

Pharmacodynamics and pharmacokinetics are two important concepts in pharmacology that describe the effects and actions of drugs in the body. Pharmacodynamics refers to the study of the biological and physiological effects of drugs, and how they interact with the body to produce their therapeutic or toxic effects. This includes the mechanisms of action of drugs,Continue reading “what is pharmacodynamics and pharmacophysiology?”