A Risk-Based Assessment for Determining the Pharmacokinetic Comparability Requirements of Biologic-Device Combination Products Administered by Subcutaneous Injection.
Mark Klitgaard Nøhr, Shaik Rizwan Waheed, Rasmus Juul Kildemoes, Vibeke Hatorp, Tine Aggerholm Bækdal, Charlotte Lindorff Adrian, Lars Peter Korsholm, Eva Lisby Arp-Hansen, Helle Holst, Scott W Roberts
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引用次数: 0
Abstract
The development of new large molecule drug therapies along with the innovation of biologic-device combination products such as prefilled syringes, autoinjectors and pen injectors have significantly impacted the treatment of new diseases and has improved the process of administering parenteral medicines. To support the regulatory approval of a new biologic-device combination products or subsequent chemistry, manufacturing and control changes impacting a combination product, sponsor companies must thoroughly assess the potential impact to product quality, safety and efficacy. In this report, a risk-based process to determine the potential impact to product quality, safety, and efficacy as well as corresponding regulatory actions supporting a chemistry, manufacturing and control change is presented. The risk assessment includes the standardized assessment of a) chemistry, manufacturing and control risk factors, potential responses and appropriately weighted scoring; b) pharmacokinetic risk factors, potential responses and appropriately weighted scoring; and c) the use of a 2-dimensional risk grid to combine the chemistry, manufacturing and control risks and pharmacokinetic risks to provide a regulatory recommendation. Three case studies (two clinical case studies and a post-approval case study) are provided to demonstrate the assessment process and capabilities.
期刊介绍:
The AAPS Journal, an official journal of the American Association of Pharmaceutical Scientists (AAPS), publishes novel and significant findings in the various areas of pharmaceutical sciences impacting human and veterinary therapeutics, including:
· Drug Design and Discovery
· Pharmaceutical Biotechnology
· Biopharmaceutics, Formulation, and Drug Delivery
· Metabolism and Transport
· Pharmacokinetics, Pharmacodynamics, and Pharmacometrics
· Translational Research
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