帕尔博西克利布囊:在养条件下对健康受试者进行生物等价性研究,以比较两个配方
Marcelo Gomes Davanço1, Thaís Pereira Vespasiano1, Jessé Moisan2
1Medical & Clinical Affairs Department, United Medical Ltda. (a Knight Therapeutics Company), Sao Paulo 04085-001, SP, Brazil.
Pharmaceutics
|February 27, 2026
概括
这项研究在健康志愿者中证明了通用palbociclib囊和参考产品之间的生物等价性. 这两种palbociclib配方都耐受良好,支持对品牌仿制药的监管批准.
科学领域:
- 药理动力学和药物新陈代谢
- 临床药理学 临床药理学
- 制药科学 制药科学
背景情况:
- 乳腺癌是全球领先的女性癌症,激素受体阳性 (HR+) 晚期病例通常用CDK4/6抑制剂治疗,如palbociclib.
- 帕尔博西克利布是HR+晚期乳腺癌的关键治疗方法,需要可获得的通用替代品.
研究的目的:
- 评估一种新的palbociclib囊配方的生物等价性和耐受性.
- 为了支持在拉丁美洲市场的品牌通用palbociclib产品的监管提交.
主要方法:
- 一个开放标签,随机,单剂量,两期交叉研究在健康的参与者.
- 在食条件下,对比一个测试palbociclib 125 mg囊 (Laboratório LKM S.A.) 与参考Ibrance® 125 mg囊 (Pfizer).
- 使用LC-MS/MS计算palbociclib血度的药理动力学分析,参数通过非分区方法计算.
主要成果:
- 对Cmax和AUC0-72的几何平均比率 (90%CI) 分别为107.07% (101.98-112.42) 和109.77% (106.51-113.13).
- 该研究招募了52名健康受试者,其中50人完成了试验.
结论:
- 测试的palbociclib囊配方证明了与参考产品的生物等价性,符合监管标准.
- 两种palbociclib配方在健康的研究参与者中都表现出良好的耐受性.
更多相关视频
相关概念视频
Bioavailability Study Design: Healthy Subjects Versus Patients
192
Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
192
Bioequivalence: Overview
2.1K
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,...
2.1K
Bioequivalence studies: Biowaivers
332
Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
332
Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules
380
Bioequivalence in generic drugs, such as tablets and capsules, refers to their pharmaceutical equivalence to the brand-name counterparts. However, for therapeutic equivalence, manufacturers must also consider physical attributes like size, shape, and weight (FDA Guidance for Industry, December 2003). Discrepancies in these aspects could impact patient compliance and cause medication errors. For instance, swallowing difficulties, often experienced with larger tablets or capsules, can lead to...
380
Bioavailability Study Design: Single Versus Multiple Dose Studies
286
Bioavailability studies are essential for understanding how a drug is absorbed, distributed, metabolized, and excreted in the body. These studies assess the extent and rate at which the active pharmaceutical agent becomes available at the site of action. The design of bioavailability studies can involve single-dose or multiple-dose regimens, each with distinct advantages and limitations.Single-dose studies are the preferred approach due to their simplicity and reduced drug exposure for...
286
Modified-Release Drug Delivery Systems: Bioavailability
58
Modified-release (MR) dosage forms are designed to extend drug release over time, thereby maintaining stable plasma concentrations and reducing dosing frequency. However, their bioavailability is typically below 100% due to incomplete drug release and presystemic metabolism, and limitations in drug permeability across the gastrointestinal epithelium, all of which can restrict the fraction of the drug reaching systemic circulation. Consequently, studying the in vivo bioavailability of MR...
58


