These studies determine whether the drug has the desired profile of action in model systems. The models are selected to provide as reliable an index of efficacy in man as possible.
這些研究將確定該藥在模型系統(tǒng)中是否具有預(yù)期的作用。模型的選擇應(yīng)盡可能使其提供可信的人體功效指標(biāo)。
Several models are usually employed. The models may be simple or complex and include:
(1) Cell cultures or bacteria;
(2) Partially purified enzymes or subcellular particles;
(3) Isolated tissues;
(4) Perfused organs;
(5) Intact animals from mice to primates.
以下是幾種常用模型,簡(jiǎn)單型和復(fù)雜型兼而有之:
(1)細(xì)胞培養(yǎng)或細(xì)菌培養(yǎng);
⑵部分提純的酶或亞細(xì)胞粒子;
⑴離體組織;
⑷灌注器官;
(5)從小鼠到靈長(zhǎng)類的正常無損傷動(dòng)物。
The object is to identify therapeutically useful pharmacological activity and to characterize these actions using established models and drugs of known action.
When drugs with specific actions on enzymes or receptors are being studied, relatively simple cell free systems or isolated tissue preparations can be used3. When poorly characterized subjective actions are sought, particularly involving behavioral effects, it may be necessary to perform tests in conscious intact animals.
該目標(biāo)旨在確立其在治療上具備有效的藥理學(xué)作用,并通過使甩已知模型和療效確定的藥物來描述這些作用。
在研究藥物對(duì)酶或受體的特異性效用時(shí),可選擇相對(duì)簡(jiǎn)單的、較為獨(dú)立的系統(tǒng)或組織施藥。如果將特征不明顯的主觀行為作為研究對(duì)象,特別是涉及行為效果時(shí),則有必要在意識(shí)健全的動(dòng)物身上進(jìn)行試驗(yàn)。
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