Batchelor Hannah, Ernest Terry, Flanagan Talia, Klein Sandra, Turner Roy, Fotaki Nikoletta, Storey David
School of Pharmacy, Institute of Clinical Sciences, Robert Aitken Building, University of Birmingham, Edgbaston, B15 2TT, UK.
GlaxoSmithKline, New Frontiers Science Park, Third Avenue, Harlow, Essex CM19 5AW, UK.
Int J Pharm. 2016 Sep 25;511(2):1151-7. doi: 10.1016/j.ijpharm.2016.06.115. Epub 2016 Jun 25.
The aim of this research survey was to understand current global thinking around the need for and development of a paediatric biopharmaceutics classification system (pBCS) to be used for the development of paediatric medicines and regulatory purposes (e.g. Biowaivers). A literature review highlighted the paucity of data in this area and therefore a survey was developed to better understand this topic to identify areas of common thinking and highlight future research needs. Global experts in paediatric biopharmaceutics were identified from existing networks and public forums. An online survey was developed and circulated broadly to maximise participation. Sixty individuals (including academics, health care professionals, pharmaceutical industry scientists and regulators) completed the survey, bringing together their views on the need for a pBCS. The results highlighted that the area of greatest concern was the definition of BCS II and IV drugs within this population and additional research is required to generate evidence to underpin this issue. In questions relating to permeability and dissolution consensus was generally reached within the expert population suggesting that little additional research is required to define suitable criteria. More than 90% of those experts who participated agreed that a pBCS would be useful for paediatric populations with a greater need identified for the younger populations (newborn and infants compared to adolescents). The results presented will facilitate further discussion and research into the evidence to underpin a relevant pBCS. These results highlight the need for additional evidence and guidance in this area.
本研究调查的目的是了解当前全球对于用于儿科药物研发及监管目的（如生物豁免）的儿科生物药剂学分类系统（pBCS）的必要性及开发的看法。文献综述凸显了该领域数据的匮乏，因此开展了一项调查，以更好地理解这一主题，识别共同的看法领域，并突出未来的研究需求。通过现有网络和公共论坛确定了儿科生物药剂学领域的全球专家。设计并广泛传播了一项在线调查，以最大限度地提高参与度。60个人（包括学者、医疗保健专业人员、制药行业科学家和监管人员）完成了该调查，汇集了他们对pBCS必要性的看法。结果表明，最受关注的领域是该人群中BCS II类和IV类药物的定义，需要开展更多研究以获取支撑该问题的证据。在与渗透性和溶出度相关的问题上，专家群体普遍达成了共识，这表明确定合适的标准几乎不需要更多研究。超过90%参与调查的专家认为，pBCS对儿科人群有用，其中较年幼的人群（新生儿和婴儿与青少年相比）需求更大。所呈现的结果将促进对支撑相关pBCS的证据进行进一步的讨论和研究。这些结果凸显了该领域对更多证据和指导的需求。
