根据现行药典生产的强效制剂临床前研究科学指南--PrePoP 指南。

IF 4.2 2区医学 Q1 INTEGRATIVE & COMPLEMENTARY MEDICINE

Journal of Integrative Medicine-Jim Pub Date : 2024-09-01 DOI:10.1016/j.joim.2024.06.005

Alexander L. Tournier , Leoni V. Bonamin , Susann Buchheim-Schmidt , Steven Cartwright , Christoph Dombrowsky , Paul Doesburg , Carla Holandino , Maria Olga Kokornaczyk , Everine B. van de Kraats , Jesús Antonio López-Carvallo , Papiya Nandy , José Manuel Mazón-Suástegui , Fateme Mirzajani , Bernard Poitevin , Claudia Scherr , Karin Thieves , Sandra Würtenberger , Stephan Baumgartner

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引用次数: 0

摘要

目的：药典规范了用于补充医学和综合医学不同分支的强效药物制剂的生产。这些制剂的理化性质和生物活性通常在临床前研究中进行调查，但目前该领域尚无实验研究指南。本 PrePoP 指南旨在提供建议，促进对强效制剂进行高质量、统计合理且可重复的临床前研究：方法：采用简化的德尔菲共识法收集相关科学协会提名的研究人员的意见，内容涵盖该领域基本研究方法的最相关方面，包括适当的对照、样本制备和处理以及统计。经过三轮反馈后，最终就对强效制剂进行高质量研究的最重要方面和注意事项达成了共识：我们就一系列主题提出了一系列建议，包括实验控制、系统稳定性、盲法和随机化、环境影响以及特效样本和对照组的制备程序，我们还讨论了这一研究领域的一些具体挑战：专家共识过程为强效制剂研究制定了一套强有力的方法指南，并提供了一个宝贵的框架，将为这一新兴领域的后续研究提供信息并提高其质量：Tournier AL、Bonamin LV、Buchheim-Schmidt S、Cartwright S、Dombrowsky C、Doesburg P、Holandino C、Kokornaczyk MO、van de Kraats EB、López-Carvallo JA、Nandy P、Mazón-Suástegui JM、Mirzajani F、Poitevin B、Scherr C、Thieves K、Würtenberger S、Baumgartner S。根据现行药典生产的强效制剂临床前研究科学指南--PrePoP 指南。J Integr Med.2024; Epub ahead of print.

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Scientific guidelines for preclinical research on potentised preparations manufactured according to current pharmacopoeias—the PrePoP guidelines

Objective

Pharmacopoeias regulate the manufacture of potentised pharmaceutical preparations used in different branches of complementary and integrative medicine. The physicochemical properties and biological activity of these preparations are often investigated in preclinical research, yet no guidelines for experimental research currently exist in this area. The present PrePoP guidelines aim to provide recommendations to promote high-quality, statistically sound, and reproducible preclinical research on potentised preparations.

Methods

Input was gathered from researchers nominated by the relevant scientific societies using a simplified Delphi consensus approach covering the most relevant aspects of basic research methodology in the field including appropriate controls, sample preparation and handling, and statistics. After three rounds of feedback, a consensus was finally reached on the most important aspects and considerations for conducting high-quality research on potentised preparations.

Results

We present a series of recommendations on a range of topics including experimental controls, system stability, blinding and randomisation, environmental influences, and procedures for the preparation of potentised samples and controls, and we address some specific challenges of this research field.

Conclusion

This expert consensus process resulted in a robust set of methodological guidelines for research on potentised preparations and provides a valuable framework that will inform and improve the quality of subsequent research in this emerging field.

Please cite this article as

Tournier AL, Bonamin LV, Buchheim-Schmidt S, Cartwright S, Dombrowsky C, Doesburg P, Holandino C, Kokornaczyk MO, van de Kraats EB, López-Carvallo JA, Nandy P, Mazón-Suástegui JM, Mirzajani F, Poitevin B, Scherr C, Thieves K, Würtenberger S, Baumgartner S. Scientific guidelines for preclinical research on potentised preparations manufactured according to current pharmacopoeias—the PrePoP guidelines. J Integr Med. 2024; 22(5): 533–544.

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来源期刊

Journal of Integrative Medicine-Jim Medicine-Complementary and Alternative Medicine

CiteScore

9.20

自引率

4.20%

发文量

3319

期刊介绍： The predecessor of JIM is the Journal of Chinese Integrative Medicine (Zhong Xi Yi Jie He Xue Bao). With this new, English-language publication, we are committed to make JIM an international platform for publishing high-quality papers on complementary and alternative medicine (CAM) and an open forum in which the different professions and international scholarly communities can exchange views, share research and their clinical experience, discuss CAM education, and confer about issues and problems in our various disciplines and in CAM as a whole in order to promote integrative medicine. JIM is indexed/abstracted in: MEDLINE/PubMed, ScienceDirect, Emerging Sources Citation Index (ESCI), Scopus, Embase, Chemical Abstracts (CA), CAB Abstracts, EBSCO, WPRIM, JST China, Chinese Science Citation Database (CSCD), and China National Knowledge Infrastructure (CNKI). JIM Editorial Office uses ThomsonReuters ScholarOne Manuscripts as submitting and review system (submission link: http://mc03.manuscriptcentral.com/jcim-en). JIM is published bimonthly. Manuscripts submitted to JIM should be written in English. Article types include but are not limited to randomized controlled and pragmatic trials, translational and patient-centered effectiveness outcome studies, case series and reports, clinical trial protocols, preclinical and basic science studies, systematic reviews and meta-analyses, papers on methodology and CAM history or education, conference proceedings, editorials, commentaries, short communications, book reviews, and letters to the editor. Our purpose is to publish a prestigious international journal for studies in integrative medicine. To achieve this aim, we seek to publish high-quality papers on any aspects of integrative medicine, such as acupuncture and traditional Chinese medicine, Ayurveda medicine, herbal medicine, homeopathy, nutrition, chiropractic, mind-body medicine, taichi, qigong, meditation, and any other modalities of CAM; our commitment to international scope ensures that research and progress from all regions of the world are widely covered. These ensure that articles published in JIM have the maximum exposure to the international scholarly community. JIM can help its authors let their papers reach the widest possible range of readers, and let all those who share an interest in their research field be concerned with their study.