Regulatory requirements for regenerative medicine: From research to clinical application

2006 ◽  
Vol 39 ◽  
pp. S217
Author(s):  
S. Kloth
Pharmaceutics ◽  
2021 ◽  
Vol 13 (12) ◽  
pp. 2091
Author(s):  
Ana Sara Cordeiro ◽  
Yogita Patil-Sen ◽  
Maitreyi Shivkumar ◽  
Ronak Patel ◽  
Abdulwahhab Khedr ◽  
...  

Viral infections causing pandemics and chronic diseases are the main culprits implicated in devastating global clinical and socioeconomic impacts, as clearly manifested during the current COVID-19 pandemic. Immunoprophylaxis via mass immunisation with vaccines has been shown to be an efficient strategy to control such viral infections, with the successful and recently accelerated development of different types of vaccines, thanks to the advanced biotechnological techniques involved in the upstream and downstream processing of these products. However, there is still much work to be done for the improvement of efficacy and safety when it comes to the choice of delivery systems, formulations, dosage form and route of administration, which are not only crucial for immunisation effectiveness, but also for vaccine stability, dose frequency, patient convenience and logistics for mass immunisation. In this review, we discuss the main vaccine delivery systems and associated challenges, as well as the recent success in developing nanomaterials-based and advanced delivery systems to tackle these challenges. Manufacturing and regulatory requirements for the development of these systems for successful clinical and marketing authorisation were also considered. Here, we comprehensively review nanovaccines from development to clinical application, which will be relevant to vaccine developers, regulators, and clinicians.


Health Policy ◽  
2008 ◽  
Vol 88 (1) ◽  
pp. 62-72 ◽  
Author(s):  
Mina Tsubouchi ◽  
Shigeyuki Matsui ◽  
Yoshiro Banno ◽  
Kiyoshi Kurokawa ◽  
Koji Kawakami

2011 ◽  
Vol 15 (07) ◽  
pp. 15-28 ◽  

The clinical application of stem cells in hematopoietic disease. Use of pluripotent stem cells and their differentiated products in pharmacological drug discovery and safety testing. Messages from the nucleus: Insights into Aging. inStem: The Institute for Stem Cell Biology and Regenerative Medicine.


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