将药物开发作为一种专业。

IF 3.1 Q2 PHARMACOLOGY & PHARMACY
Pravin Chopra
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引用次数: 0

摘要

在过去的几十年里,药物发展发生了巨大的变化。它已经从一个小团队承担的任务演变为一系列复杂的活动,涉及世界各地多个相互关联的科学学科的若干职能和合格的专业人员。该学科被定义为一门医学专业,涉及药物的研究、开发和监测,主要由药学医生带头,现已扩展到包括非医学合格的科学家,逐步在药物开发范围内担任传统角色。专业背景的参与也在扩大。每个单独的功能都贡献了独特的专业知识和技能,但他们都有一种认同感,一种集体承诺,以及通过创新治疗改善人类健康和福祉的共同目标。与此同时,在研发环境、医疗保健服务、监管精神、更透明的数据共享、指数级数字化以及对患者结果的重视方面取得了里程碑式的进步,这使得系统和流程以及所有全球利益相关者都承担了更大的责任。越来越多地,这需要一个共同的目标,促进持续学习,并在药物开发社区中产生一种专业身份,这是一种逐渐获得等同于药学医学的肯定的新发明。在涉及的多专业团队中,一致的相关能力和能力,在不同(尽管是互补的)实践社区中同时识别的感觉,正在进行的专业知识培训的义务,强制性的企业范围内的伦理和道德行为准则,以及在学术机构,监管机构,生物制药行业——所有人都声称符合标准,并且值得药物开发/药物医学被承认、考虑和认可为一个独特的职业,以其自身的地位。自1957年以来,药物医学的概念已经浮出水面,多年来在科学文献中受到了相当大的关注。然而,这门学科很难被普遍理解和欣赏。这一观点审视了相关的产生影响和阻碍因素,同时提倡促进药物开发,使其从传统职业发展成为一种职业,并转变为一种成熟的职业,其愿景和目的是促进更好的药物,改善全球人民的健康结果。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Embracing Medicines Development as a Profession.

Medicines development has dramatically transformed in the preceding decades. It has evolved from a task undertaken by a small team to a complex series of activities, involving several functions and qualified professionals, across multiple, interrelated, scientific disciplines, worldwide. Conceptualized as a medical specialty, concerned with the research, development, and monitoring of medicines, and spearheaded largely by pharmaceutical physicians, the discipline has extended to embrace non-medically qualified scientists progressively taking on traditional roles within the medicines development ambit. There is expanded engagement of professional backgrounds. Each individual function contributes unique expertise and skills, but they all share a sense of identity, a collective commitment, and a common goal of improving human health and well-being, through innovative treatments. At the same time, milestone advancements in the research and development environment, in healthcare delivery, the regulatory ethos, data sharing with greater transparency, the exponential digitalization, and the emphasis on patient outcomes have imposed greater accountability in systems and processes, and across all global stakeholders. Increasingly, this demands a joint purpose, fostering continuous learning, and engendering a professional identity within the medicines development community, a coinage gaining incremental affirmation as equivalent to pharmaceutical medicine. The aligned set of related competencies and capabilities across the multi-professional teams involved, the sense of identifying concurrently across different, albeit complementary, communities of practice, the obligation of ongoing specialized knowledge training, the mandated enterprise-wide codes of ethics and moral conduct, and the intertwined career paths within the larger business organizational construct of academic institutions, regulatory agencies, and the biopharmaceutical industry-all profess to meet the criteria, and merit medicines development/pharmaceutical medicine be acknowledged, regarded, and recognized as a distinct profession of stature, in its own standing. The concept of pharmaceutical medicine has been floated since 1957, and has received considerable attention in scientific literature over the years. Yet, the discipline struggles to be universally understood and appreciated. This perspective scrutinizes related engendering influences and hindering elements, while advocating the furtherance of medicines development from a traditional occupation, emerging as a vocation, and transforming into a mature profession, with the vision and purpose of advancing better medicines for improved health outcomes for people, globally.

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来源期刊
Pharmaceutical Medicine
Pharmaceutical Medicine PHARMACOLOGY & PHARMACY-
CiteScore
5.10
自引率
4.00%
发文量
36
期刊介绍: Pharmaceutical Medicine is a specialist discipline concerned with medical aspects of the discovery, development, evaluation, registration, regulation, monitoring, marketing, distribution and pricing of medicines, drug-device and drug-diagnostic combinations. The Journal disseminates information to support the community of professionals working in these highly inter-related functions. Key areas include translational medicine, clinical trial design, pharmacovigilance, clinical toxicology, drug regulation, clinical pharmacology, biostatistics and pharmacoeconomics. The Journal includes:Overviews of contentious or emerging issues.Comprehensive narrative reviews that provide an authoritative source of information on topical issues.Systematic reviews that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by PRISMA statement.Original research articles reporting the results of well-designed studies with a strong link to wider areas of clinical research.Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Pharmaceutical Medicine may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.All manuscripts are subject to peer review by international experts. Letters to the Editor are welcomed and will be considered for publication.
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