Insights From Our Labs to Yours
Covance Blog
To deliver on the mission of improving health and improving lives, patients need access to safe and effective treatments. As part of safety testing, abnormal toxicity tests, also known as general safety tests, are often performed when a drug manufacturer creates a batch of its licensed pharmaceutical or biotechnology-derived product.
Potency evaluation, achieved through potency assays, is essential to transition an advanced therapy medicinal product or ATMP (also known as cell and gene therapy) through pivotal clinical stages to final market authorization. However, potency is a difficult parameter to assess for ATMPs, so it is important to start developing these …
嵌合抗原受体T细胞，体外和体内临床前模型，以及最近网络研讨会的监管和安全考虑，我们提出并讨论了普及的细胞疗法临床yaboapp体育官网前计划核心in / IMPD提交。以下是简要摘要，以及从该活动中的富有洞察力Q。
As COVID-19 was declared a pandemic, Covance Clinical Trials Testing Solutions (CTTS) witnessed a sudden influx of COVID-19 studies from both large pharmaceutical organizations and biotechs. Not only did CTTS need to accelerate the timelines for these drug development sponsors’ urgent studies, but they needed to provide patient-centric testing solutions, …
随着世界等待疫苗to protect against COVID-19, the disease caused by the novel coronavirus, it will need not only scientific excellence but also business continuity excellence to keep vital research and immunogenicity studies running. Vaccine development relies on many early, nonclinical studies; some of the earliest …
BPR is the legislation governing the use of biocidal products in the European Union. Read on to find out how to navigate the authorization process and manage the information required. Biocidal products are used to control unwanted organisms (e.g., pests, such as rats, or micro-organisms, like bacteria) that are harmful …
介绍虽然存在一系列的调节定义，但生物仿制药通常定义为\生物化合物，其与参考药物高度相似，安全性，纯度和效力高度相似的临床上有意义的差异。此外，除了生物纤维生活在保持临床疗效的同时，表征降低了医疗保健成本......
The Brexit1 transition period is due to conclude on December 31, 2020 when the United Kingdom (UK) will become a third country to the European Union (EU). Drug manufacturers and contract test laboratories should be proactive in understanding the potential regulatory considerations relating to commercial drug product release testing and Brexit. …
The FDA released a Draft Guidance in December (2018) on the evidentiary framework and standards required to achieve qualified biomarkers. It is intended to cover a regulatory gap related to the use of biomarkers outside of specific drug programs. As such, this Draft Guidance supports the Qualification of Drug Development Tools …
The clinical approval of biological therapeutics inhibiting CTLA-4 (ipilimumab), PD-1 (nivolumab, pembrolizumab) and PD-L1 (atezolizumab, avelumab, durvalumab) has ushered in a revolution in the field of cancer immunotherapy. Thus far, the approvals have occurred in a small number of cancer histotypes including melanoma, non-small cell lung cancer and urothelial cancers, …