Your browser doesn't support javascript.
loading
Strategies for Accelerated Drug Development: An Industry Perspective Based on an IQ Consortium Survey of CMC Considerations.
Buist, Nicole; Krzyzaniak, Joseph; Abbas, Shermeen; Alvarez-Nunez, Fernando; Bell, Sammy; Chen, Bei; Chen, George; Chen, Shirlynn; He, Min; Hutchens, Clarice; Ibrahim, Basma; Ingram, Rebecca; Kulkarni, Mehuli; Murthy, Avinash; Tan, David Cheng Thiam; Sood, Ramesh; Ying, William; Roopwani, Rahul.
Afiliación
  • Buist N; Merck, 2000 Galloping Hill Rd, Kenilworth, NJ 07033, USA. Electronic address: nicole_buist@merck.com.
  • Krzyzaniak J; Pfizer Inc., Groton, CT 06340, USA.
  • Abbas S; Amgen, Inc. 1 Amgen Center Dr, Thousand Oaks, CA 9132.
  • Alvarez-Nunez F; Amgen, Inc. 1 Amgen Center Dr, Thousand Oaks, CA 9132.
  • Bell S; Eli Lilly and Company, Indianapolis, IN 46285, USA.
  • Chen B; Abbvie Inc., 1N Waukegan Road, North Chicago, IL 60064, USA.
  • Chen G; Daiichi Sankyo Inc., 211 Mt. Airy Road, Basking Ridge, NJ 07920, USA.
  • Chen S; Eli Lilly and Company, Indianapolis, IN 46285, USA.
  • He M; Biogen Inc., 225 Binney Street, Cambridge, MA 02142, USA.
  • Hutchens C; Pfizer Inc., Groton, CT 06340, USA.
  • Ibrahim B; Abbvie Inc., 1N Waukegan Road, North Chicago, IL 60064, USA.
  • Ingram R; Pfizer, Inc., Andover, MA 01810, USA.
  • Kulkarni M; Eli Lilly and Company, Indianapolis, IN 46285, USA.
  • Murthy A; F. Hoffmann-La Roche, Grenzacherstrasse 124, 4070 Basel, Switzerland.
  • Tan DCT; Abbvie Inc., 1N Waukegan Road, North Chicago, IL 60064, USA.
  • Sood R; Office of New Drug Product, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
  • Ying W; Bristol-Myers Squibb, 1 Squibb Drive, New Brunswick, NJ 08903, USA.
  • Roopwani R; Vertex Pharmaceuticals, 50 Northern Ave, Boston, MA 02210, USA.
J Pharm Sci ; 113(8): 2005-2022, 2024 Aug.
Article en En | MEDLINE | ID: mdl-38862091
ABSTRACT
Over the past decade, there has been an increase in accelerated drug development with successful regulatory approval that has provided rapid access of novel medicines to patients world-wide. This has created the opportunity for the pharmaceutical industry to continuously improve the process of quickly bringing new medicines to patients with unmet medical needs. This can be accomplished through sharing the learnings and advancements in drug development, enhancing regulatory interactions, and collaborating with academics on developing the underlying science to reduce drug development timelines. In this paper, the IQ Consortium - Accelerated Drug Development working group members intend to share recommendations for optimizing strategies that build efficiencies in accelerated pathways for regulatory approval. Information was obtained by surveying member pharmaceutical companies with respect to recent expedited submissions within the past 5 years to gain insights as to which development strategies were successful. The learnings from this analysis are provided, which includes shared learnings in formulation development, stability, analytical methods, manufacturing, and importation testing as well as regulatory considerations. Each of these sections provide a summary illustrating the key data collected as well as a discussion that is aimed to guide pharmaceutical companies on strategies to consider streamlining development activities and expedite the drug to market.
Asunto(s)
Palabras clave
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Industria Farmacéutica / Desarrollo de Medicamentos Límite: Humans Idioma: En Revista: J Pharm Sci Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Industria Farmacéutica / Desarrollo de Medicamentos Límite: Humans Idioma: En Revista: J Pharm Sci Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos