Safety와 Tolerability의 차이 (feat. Chat GPT)

 

Safety: 약물의 약효(주작용)가 아닌 부작용(Adverse effects)/ 위험의 정도

            - 예를 들어 하나의 약에 다양한 효과가 있을 경우, 기대한 효과를 주작용 기대하지 않았던 효과를 부작용이라고 함

            - 삭센다의 경우, 최초 개발 시 부작용이 체중 감소였는데 -> 추후 이 부작용을 주작용으로 한 비만 치료제를 개발함

            - Safety의 규명은 side effect, 관련 potential risk 를 감수할만큼 약효 (efficacy)가 뛰어난지를 평가하는 목적

 

Tolerability: 환자 관점에서 환자가 부작용을 견딜 수 있는 정도

             - 부작용의 severity, frequency, duration, and impact와 qulaity of life를 고려함

             - 환자의 약물의 acceptance, compliance 및 adherence에 영향을 미침  

 

 

아래는 Chat GPT 원문

 

Safety and tolerability are two related but distinct concepts in the context of healthcare and medical interventions. Here's an explanation of their differences:

1. Safety: Safety refers to the degree to which a medical intervention or treatment avoids harm or adverse effects on the individual receiving it. It focuses on assessing the risks associated with a particular intervention and evaluating the potential for adverse events or complications. Safety considerations involve monitoring and managing side effects, allergic reactions, drug interactions, and other potential risks that may arise from the use of a medication, medical device, or treatment procedure. The goal is to ensure that the benefits of the intervention outweigh the potential risks to the patient's health.
2. Tolerability: Tolerability refers to the extent to which an individual can withstand or tolerate the adverse effects or discomfort caused by a medical intervention. It assesses the individual's ability to endure the undesirable effects of a treatment without experiencing undue distress or harm. Tolerability takes into account factors such as the severity, frequency, duration, and impact of adverse events on the patient's quality of life. The assessment of tolerability helps determine the acceptability of a treatment from the patient's perspective and influences treatment adherence and compliance.

In summary, safety focuses on evaluating and managing the potential risks and adverse effects of a medical intervention, while tolerability assesses the patient's ability to endure and tolerate those effects without significant distress or harm. Both concepts are important in healthcare to ensure that treatments are effective, minimize harm, and optimize the overall well-being of the patient.