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 ochernen

link 28.06.2019 17:12 
Subject: PK exposure-response relationships with efficacy and safety parameters med.
Помогите понять смысл цели клинического исследования лекарственного препарата

To evaluate PK exposure-response relationships with efficacy and safety parameters.

PK exposure-response это вероятно  pharmacokinetic ( PK) exposure-response

Что за взаимосвязь здесь исследуется?

Оценить фармакокинетику, взаимосвязь воздействие ответ и параметры эффективности и безопасности?

Или..

Что?

Смысл предложения не могу понять. Пропущено явно что-то..

Благодарю заранее.

 A.Rezvov

link 28.06.2019 18:17 
Не об этом ли речь?

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The dose–response relationship, or exposure–response relationship, describes the magnitude of the response of an organism, as a function of exposure (or doses) to a stimulus or stressor (usually a chemical) after a certain exposure time.[1] Dose–response relationships can be described by dose–response curves. This is explained further in the following sections. A stimulus response function  or stimulus response curve is defined more broadly as the response from any type of stimulus, not limited to chemicals.

https://en.wikipedia.org/wiki/Dose-response_relationship

 A.Rezvov

link 28.06.2019 18:40 
А вот еще интересное:

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The term ‘‘ exposure–response relationship ’’ will be used here to refer to the form of the association between an outcome of interest and some measure of exposure which is assumed to be recorded on a continuous scale .

Источник: Evaluating and interpreting exposure–response relationships for manganese and neurobehavioral outcomes,  https://faculty.washington.edu/mlt/Thompson Neurotox 2006.pdf

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В этом примере "взаимосвязь", судя по всему, - это некая функциональная зависимость одного параметра ( outcome of interest ) от другого ( measure of exposure).

 A.Rezvov

link 28.06.2019 18:53 
Dose-response relationship, effect on an organism or, more specifically, on the risk of a defined outcome produced by a given amount of an agent or a level of exposure. A dose-response relationship is one in which increasing levels of exposure are associated with either an increasing or a decreasing risk of the outcome. Demonstration of a dose-response relationship is considered strong evidence for a causal relationship between the exposure and the outcome. The chance of a causal relationship cannot be disregarded, however, even when a dose-response relationship is absent.

Exposure in investigations of dose-response relationships can be characterized in different ways, including peak exposure; duration of exposure at or above a set level; average exposure, which is a time-weighted average of exposure; or cumulative exposure, which is the sum of time-weighted exposures. In any of those instances, the increase in exposure can be in its intensity or its duration.

/.../

Odds ratios and relative risks (measures of association between exposures and outcomes) can be calculated for categories of increasing exposure, where each higher exposure is compared with a baseline exposure level. The mathematical relationship of exposure to outcome may be linear, be log linear, or follow some other pattern.

https://www.britannica.com/science/dose-response-relationship

 A.Rezvov

link 28.06.2019 19:03 
Вот названия пары статей, которые подкрепляют догадку о том, что кое-что, возможно, пропущено:

1. Population pharmacokinetic and exposure–response analysis for trastuzumab administered using a subcutaneous “manual syringe” injection or intravenously in women with HER2‑positive early breast cancer

2. Population PK and Exposure-Response Relationships for the Antibody-Drug Conjugate Brentuximab Vedotin in CTCL patients in the Phase III ALCANZA study

 Dimpassy

link 30.06.2019 7:50 
Зависимость между параметрами ответа и значениями экспозиции, а также параметры фармакокинетики, эффективность и безопасность

 ochernen

link 1.07.2019 11:25 
Благодарю Вас Dimpassy :)

 Rengo

link 1.07.2019 17:17 
Dose-effect, syn. dose-response, dose-effect relationship, exposure-response relationship / доза-эффект The relationship between the amount of exposure [dose] to a substance and the resultant changes in any of body functions or health (response). Соотношение между уровнем воздействия [дозой] вещества и вызванными ими изменениями в функциях организма или здоровья (ответ, реакция).

 ochernen

link 1.07.2019 19:15 
Благодарю Rengo :)

 

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