一个随机的,交叉研究,调查索马特罗贡-格拉在2种不同的药物产品呈现中的可比性
Allison Manners1, Joan Korth-Bradley2, Michael P Wajnrajch3
1OPKO Pharmaceuticals LLC., a subsidiary of OPKO Health, Inc., Miami, USA.
Clinical pharmacology in drug development
|June 26, 2024
概括
这项研究比较了健康成年人中的两个索马特罗贡-格拉配方. 虽然两者都显示出可比的IGF-1反应,但峰值度不同,这表明潜在的配方差异.
科学领域:
- 药理学 药理学是指药理学的学科.
- 内分泌学 在内分泌学.
- 药物输送系统 药物输送系统
背景情况:
- 索马特罗贡-格拉是一种长效复合人体生长激素,用于治疗儿科生长激素缺乏症.
- 了解配方差异对于治疗等价性至关重要.
研究的目的:
- 为了比较两个索马特罗贡-格拉配方的药理动力学和药理动力学概况.
- 为了评估冷瓶和预填笔呈现方式之间的生物等价性.
主要方法:
- 在49名健康的成年男性中进行的一项随机交叉研究.
- 通过小瓶或笔进行皮下注射索马特罗贡-格拉,并进行2周的洗.
- 在剂后240小时内测量索马特龙,IGF-I和IGFBP-3度.
主要成果:
- 对度-时间曲线下的索马特龙区域和IGF-1反应证明了生物等价性.
- 索马特龙度的峰值不符合生物等价性标准 (90% CI下限为74.2%与80.0%).
- 报告了轻度不良事件,包括头痛和注射部位反应.
结论:
- 这两种索马特龙-格拉配方在很大程度上是可比的,特别是在整体暴露和IGF-1反应方面.
- 峰值度的差异值得考虑,尽管建议进行整体治疗可比性.
相关概念视频
Bioequivalence: Overview
983
Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
983
Clinical Trials: Overview
2.9K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
2.9K
Drug Nomenclature
1.7K
During the development of a new pharmaceutical, the manufacturer initially assigns a code name to the drug. Once approved, the drug receives a United States Adopted Name (USAN)—a generic, nonproprietary designation. Upon being listed in the United States Pharmacopeia, this nonproprietary name becomes the drug's official name. Additionally, the manufacturer assigns a proprietary name or trademark, which serves as the brand name under which the drug is marketed. It is worth noting that...
1.7K
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
125
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
125
Agonism and Antagonism: Quantification
352
When drugs are administered, they can elicit either an agonist or antagonist effect on the body. Agonism occurs when a drug activates a specific receptor, triggering a biological response. On the other hand, antagonism happens when a drug binds to the same receptors but blocks their activation, thereby preventing a biological response.
To quantify these effects, researchers use a dose-response curve, which provides valuable information about the potency and efficacy of a drug. Potency refers to...
To quantify these effects, researchers use a dose-response curve, which provides valuable information about the potency and efficacy of a drug. Potency refers to...
352
Drug Dosage Regimen: Overview
3.5K
A drug dosage regimen describes the specific instructions and schedule for administering a drug to a patient. It considers factors such as drug dosage, frequency, route of administration, and duration of treatment. Designing an appropriate dosage regimen for a patient aims to achieve a target drug concentration at the site of action.
Typically, the starting dose and dosing interval are guided by the manufacturer's recommendations based on clinical trials conducted during and after drug...
Typically, the starting dose and dosing interval are guided by the manufacturer's recommendations based on clinical trials conducted during and after drug...
3.5K


