The use of the Maximum Tolerated Dose is considered a pragmatic way to evaluate potential chemical toxicity under conditions of limited animal groups, unknown animal model sensitivity, and uncertainty in dose response interpretation.

The maximum tolerated dose (MTD) is the highest dose level to which animals are exposed in toxicological studies, and is usually set for long-term studies as the dose that causes an ∼10% reduction in body-weight gain. The lower doses are set as fractions of the MTD.

最大耐受量 (Maximal Tolerable Dose)，在毒理学研究中，指全组染毒或给药的动物全部存活的最大剂量。 常用LD0表示，其数据以mg/kg为单位。 但由于动物的感受性有很大的个体差异，当实验动物增多时可能出现个别特别敏感或特别不敏感的动物，致使最大耐受量下降或加大，由于这种不稳定性，这个指标不宜应用于两种药物的毒性的对比。 [1] 最大耐受量 (MTD)， [2] 指药物在除急性毒性动物实验外的实验 (短期重复实验、亚慢性毒性实验、慢性毒性实验)中不引起实验动物死 …

现行的药物急性毒性研究技术指导原则（包括化学药和中药、天然药物）中明确：“最大耐受量（Maximal tolerance dose, MTD）：指动物能够耐受的而不引起动物死亡的最高剂量”。

在 肿瘤I期临床试验 中，主要目的是为了找到 II期推荐剂量 （RP2D）或者MTD（最大耐受剂量）。 目前肿瘤I期的设计方法已经多种多样，主要有3种： 1、基于-规则的设计（Rule-Based Design），例如 “3+3”设计 、加速滴定法. 2、基于-模型的设计（Model-Based Design），例如CRM（持续再评估法） 3、模型辅助的设计（Model-Assisted Design），例如 mTPI 、 BOIN法. 无论使用哪种方法，都绕不开一个问题：如何定义DLT（剂量限制性毒性）？ 或者说哪些情况 …

2021年7月25日 · The “Maximum Tolerable Dose” (MTD), also known as the “Maximum Tolerated Dose” or the “Maximally Tolerated Dose”, is defined as the dose that produces an “acceptable” level of toxicity or that, if exceeded, would put animals or …

However, clinicians often prescribe up to maximum tolerated dose (MTD), especially when treating acute and more severe disease, without evidence to show that MTD is more likely to improve outcomes. Cardiovascular guidelines for some indications advocate MTD even in prevention, for example hypercholesterolaemia, without compelling evidence of ...

2023年10月10日 · Generally, the high (or limit) dose in an MTD study is the dose that should be used in the absence of a general toxic effect. Typically, this dose is 1000 mg/kg in both rodents and non-rodents (ICH M3[R2] 2009). However, dosing up to 2000 mg/kg may be necessary under certain scenarios (i.e., in some situations where human drug exposure ...

2021年1月20日 · In phase I cancer clinical trials, the primary goal is to find the maximum tolerated dose (MTD). In practice, the MTD is often defined as the dose of the drug that will produce a defined dose-limiting toxicity (DLT) in a pre-specified percentage of patients.

Maximum tolerable dose (MTD) studies define the highest dose of a drug or therapy that does not cause unacceptable side effects or toxicity. These studies help determine safe starting doses for first in-human (FIH) clinical trials and may continue during the development of …