Safety assessment post-licensure

Miller, E.; Waight, P. and Farrington, P. (1998). Safety assessment post-licensure. In: Plotkin, S. A.; Brown, F. and Horaud, F. eds. Preclinical and Clinical Development of New Vaccines. Developments in Biologicals (95). Karger, pp. 235–243.



About the book:
This publication covers all aspects of new vaccine development from the preclinical stage to licensing. It contains discussions about the preclinical testing which is necessary to obtain permission to test a new vaccine in clinical trials and to organize a clinical plan that will demonstrate the safety and efficacy of a new vaccine.

In addition, some aspects of newer strategies, such as DNA immunization, are presented as well as a number of theoretical issues relating to vaccination, such as immunological correlates of protection, interference with immune responses, combination of vaccines, and the natural history of disease. Much attention is devoted to the proof of efficacy, a process which is both expensive and complicated.

This volume is important reading for all scientists interested in vaccine development, especially those working in industry, government and public health authorities.

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