Integrating 3Rs approaches in WHO guidelines for the batch release testing of biologicals: Responses from a survey of National Control Laboratories and National Regulatory Authorities.

Lilley, Elliot; Bruysters, Martijn; Das, Pradip; Gill, Simeon; Isbrucker, Richard; Jones, David; Holmes, Anthony

Lilley, Elliot; Bruysters, Martijn; Das, Pradip; Gill, Simeon; Isbrucker, Richard; Jones, David; Holmes, Anthony.

Afiliação

Lilley E; NC3Rs, London, UK. Electronic address: elliot.lilley@nc3rs.org.uk.
Bruysters M; National Institute of Public Health and the Environment, Bilthoven, the Netherlands.
Das P; Biological E Limited, Hyderabad, India.
Gill S; AstraZeneca, Cambridge, UK.
Isbrucker R; World Health Organisation, Geneva, Switzerland.
Jones D; Consultant - formally MHRA, UK.
Holmes A; NC3Rs, London, UK.

Biologicals ; 84: 101721, 2023 Nov.

Article em En | MEDLINE | ID: mdl-37922625

Assuntos

Laboratórios; Vacinas; Humanos; Animais; Fatores Biológicos; Controle de Qualidade; Inquéritos e Questionários

Palavras-chave

3Rs; Batch release testing; Biological therapeutics; NC3Rs; National Control Laboratories; National Regulatory Authorities; Non-animal testing strategies; Quality control; Survey; Vaccine manufacturers; Vaccines; WHO

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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Vacinas / Laboratórios Limite: Animals / Humans Idioma: En Ano de publicação: 2023 Tipo de documento: Article

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