对Crudele等人的回应。对Gudin等人“篡改对两种具有防滥用特性的羟考酮缓释制剂口服药代动力学特征的影响的比较”的评论

J. Gudin, E. Kopecky, A. Fleming
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引用次数: 1

摘要

尊敬的编辑,我们感谢Crudele和同事花时间阅读我们的出版物“比较篡改对两种具有抗滥用特性的羟考酮缓释制剂的口服药代动力学特征的影响”[1],其中比较了操纵Xtampza缓释(ER)和操纵重新配制的奥施康定的药代动力学(PK)特征。我们非常感谢编辑们给我们一个回复他们评论的机会。Crudele指出,这篇论文“暗示这些PK结果得到了比较药效学(药物喜欢效应)或人类滥用潜力研究数据的支持,而事实并非如此。”参考文献中的研究(Gudin et al. 2015)[1]没有收集比较药效学数据,因为操纵处理组的PK结果差异非常明显,并且是独立的:粉碎的Xtampza ER(羟考酮)的PK谱与完整的Xtampza ER具有生物等效性(图1A)[1]。这与压碎后的奥施康定(盐酸羟考酮)的情况形成对比,后者与压碎后的奥施康定完全不同,与压碎后的羟考酮片具有生物等效性(图1B)[1]。参考研究中提供的数据最近在第二项研究中得到了重复[2],并且是…
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Response to Crudele et al. Commentary on Gudin et al. “Comparing the Effect of Tampering on the Oral Pharmacokinetic Profiles of Two Extended-Release Oxycodone Formulations with Abuse-Deterrent Properties”
Dear Editor, We appreciate Crudele and colleagues taking the time to read our publication “Comparing the Effect of Tampering on the Oral Pharmacokinetic Profiles of Two Extended-Release Oxycodone Formulations with Abuse-Deterrent Properties” [1], in which the pharmacokinetic (PK) profiles of manipulated Xtampza extended release (ER) were compared with manipulated reformulated OxyContin. We are grateful to the editors for a chance to respond to their comments. Crudele states that the paper “implies that these PK results are supported by comparative pharmacodynamic (drug liking effects) or human abuse potential study data, when such is not the case.” The study in reference (Gudin et al. 2015) [1] did not collect comparative pharmacodynamic data as the differences of the PK results of the manipulated treatment groups were quite compelling and stand on their own: Crushed Xtampza ER (oxycodone) had a PK profile that was bioequivalent to Xtampza ER taken intact (Figure 1A) [1]. This was in contrast to the crushed OxyContin (oxycodone HCl) profile, which was significantly different than OxyContin taken intact and bioequivalent to crushed immediate-release oxycodone tablets (Figure 1B) [1]. The data presented in the referenced study have been recently duplicated in a second study [2] and are …
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