Chapter title |
Glycoconjugate Vaccines: The Regulatory Framework
|
---|---|
Chapter number | 14 |
Book title |
Carbohydrate-Based Vaccines
|
Published in |
Methods in molecular biology, January 2015
|
DOI | 10.1007/978-1-4939-2874-3_14 |
Pubmed ID | |
Book ISBNs |
978-1-4939-2873-6, 978-1-4939-2874-3
|
Authors |
Christopher Jones, Jones, Christopher |
Abstract |
Most vaccines, including the currently available glycoconjugate vaccines, are administered to healthy infants, to prevent future disease. The safety of a prospective vaccine is a key prerequisite for approval. Undesired side effects would not only have the potential to damage the individual infant but also lead to a loss of confidence in the respective vaccine-or vaccines in general-on a population level. Thus, regulatory requirements, particularly with regard to safety, are extremely rigorous. This chapter highlights regulatory aspects on carbohydrate-based vaccines with an emphasis on analytical approaches to ensure the consistent quality of successive manufacturing lots. |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Unknown | 11 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Student > Ph. D. Student | 3 | 27% |
Researcher | 1 | 9% |
Other | 1 | 9% |
Student > Postgraduate | 1 | 9% |
Unknown | 5 | 45% |
Readers by discipline | Count | As % |
---|---|---|
Pharmacology, Toxicology and Pharmaceutical Science | 2 | 18% |
Chemistry | 2 | 18% |
Biochemistry, Genetics and Molecular Biology | 1 | 9% |
Medicine and Dentistry | 1 | 9% |
Unknown | 5 | 45% |