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A Risk-Based Assessment for Determining the Pharmacokinetic Comparability Requirements of Biologic-Device Combination Products Administered by Subcutaneous Injection.
Nøhr, Mark Klitgaard; Waheed, Shaik Rizwan; Kildemoes, Rasmus Juul; Hatorp, Vibeke; Bækdal, Tine Aggerholm; Adrian, Charlotte Lindorff; Korsholm, Lars Peter; Arp-Hansen, Eva Lisby; Holst, Helle; Roberts, Scott W.
Afiliación
  • Nøhr MK; Regulatory Affairs, Chemistry, Manufacturing and Controls, Novo Nordisk A/S, Søborg, Denmark.
  • Waheed SR; Regulatory Affairs, Device, Novo Nordisk A/S, Søborg, Denmark.
  • Kildemoes RJ; Medical & Science Clinical Pharmacology, Novo Nordisk A/S, Søborg, Denmark.
  • Hatorp V; Medical & Science Clinical Pharmacology, Novo Nordisk A/S, Søborg, Denmark.
  • Bækdal TA; Medical & Science Clinical Pharmacology, Novo Nordisk A/S, Søborg, Denmark.
  • Adrian CL; Medical & Science Clinical Pharmacology, Novo Nordisk A/S, Søborg, Denmark.
  • Korsholm LP; Biostatistics Research and Development, Novo Nordisk A/S, Søborg, Denmark.
  • Arp-Hansen EL; Global Regulatory Affairs, Novo Nordisk A/S, Søborg, Denmark.
  • Holst H; Medical & Science Rare Endocrine Disorders, LCM & Cell Therapies, Novo Nordisk A/S, Søborg, Denmark.
  • Roberts SW; Regulatory Affairs, Chemistry, Manufacturing and Controls, Novo Nordisk A/S, Søborg, Denmark. osrb@novonordisk.com.
AAPS J ; 26(5): 100, 2024 Sep 04.
Article en En | MEDLINE | ID: mdl-39231891
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Productos Biológicos Límite: Humans Idioma: En Revista: AAPS J Asunto de la revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2024 Tipo del documento: Article País de afiliación: Dinamarca Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Productos Biológicos Límite: Humans Idioma: En Revista: AAPS J Asunto de la revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2024 Tipo del documento: Article País de afiliación: Dinamarca Pais de publicación: Estados Unidos