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Global harmonization of vaccine testing requirements: Making elimination of the ATT and TABST a concrete global achievement.
Viviani, Laura; Halder, Marlies; Gruber, Marion; Bruckner, Lukas; Cussler, Klaus; Sanyal, Gautam; Srinivas, Geetha; Goel, Sunil; Kaashoek, Marianne; Litthauer, Derek; Lopes da Silva, Arthur Leonardo; Sakanyan, Elena; Aprea, Patricia; Jin, Hongtao; Vandeputte, Joris; Seidle, Troy; Yakunin, Dimitriy.
Afiliação
  • Viviani L; Humane Society International, Switzerland. Electronic address: lviviani@hsi.org.
  • Halder M; European Commission Joint Research Centre, Italy.
  • Gruber M; FDA Center for Biologics Evaluation and Research, USA.
  • Bruckner L; EDQM-nominated Expert, Switzerland.
  • Cussler K; Paul-Ehrlich-Institut, EDQM-nominated Expert, Germany.
  • Sanyal G; Vaccines Analytics, USA.
  • Srinivas G; USDA Center for Veterinary Biologics, USA.
  • Goel S; Serum Institute of India Pvt Ltd., India.
  • Kaashoek M; MSD Animal Health, VAC2VAC-nominated Expert, the Netherlands.
  • Litthauer D; University of Free State / National Control Laboratory, South Africa.
  • Lopes da Silva AL; ANVISA, Brazilian Pharmacopoeia Coordination (COFAR), Brazil.
  • Sakanyan E; Russian Pharmacopoeia Committee, FSBI "SCEEMP" of Ministry of Health, Russia.
  • Aprea P; National Administration of Drugs, Foods and Medical Devices (ANMAT), Argentina.
  • Jin H; New Drug Safety Evaluation Center of Chinese Academy of Medical Sciences, China.
  • Vandeputte J; International Alliance for Biological Standardization, Belgium.
  • Seidle T; Humane Society International, Switzerland.
  • Yakunin D; Moscow Laboratory of Control of Medicines, FSBI "IMCESACMP", Roszdravnadzor, Russia.
Biologicals ; 63: 101-105, 2020 Jan.
Article em En | MEDLINE | ID: mdl-31699501
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Controle de Qualidade / Vacinas / Testes de Toxicidade / Alternativas aos Testes com Animais Limite: Animals Idioma: En Ano de publicação: 2020 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Controle de Qualidade / Vacinas / Testes de Toxicidade / Alternativas aos Testes com Animais Limite: Animals Idioma: En Ano de publicação: 2020 Tipo de documento: Article