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Outcomes of the European Federation of Pharmaceutical Industries and Associations Oligonucleotide Working Group Survey on Nonclinical Practices and Regulatory Expectations for Therapeutic Oligonucleotide Safety Assessment.
Tessier, Yann; Achanzar, William; Mihalcik, Lauren; Amuzie, Chidozie; Andersson, Patrik; Parry, Joel D; Moggs, Jonathan; Whiteley, Laurence O.
Afiliação
  • Tessier Y; Pharmaceutical Sciences, Roche Pharma Research and Early Development, F. Hoffmann-La Roche Ltd., Basel, Switzerland.
  • Achanzar W; Drug Safety Evaluation, Bristol Myers Squibb Company, New Brunswick, New Jersey, USA.
  • Mihalcik L; Amgen Research, Translational Safety & Bioanalytical Sciences, South San Francisco, California, USA.
  • Amuzie C; Janssen Pharmaceutical Companies of Johnson & Johnson, Spring House, Pennsylvania, USA.
  • Andersson P; Respiratory and Immunology Safety, Clinical Pharmacology and Safety Sciences, R&D, AstraZeneca, Gothenburg, Sweden.
  • Parry JD; Nonclinical Safety, GSK R&D, David Jack Centre for R&D, Ware, United Kingdom.
  • Moggs J; Preclinical Safety, Translational Medicine, Novartis Institutes for BioMedical Research, Basel, Switzerland.
  • Whiteley LO; Pfizer Drug Safety Research and Development, Cambridge, Massachusetts, USA.
Nucleic Acid Ther ; 31(1): 7-20, 2021 02.
Article em En | MEDLINE | ID: mdl-33054599

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Oligonucleotídeos / Terapia Genética / Avaliação Pré-Clínica de Medicamentos Tipo de estudo: Guideline / Risk_factors_studies Limite: Humans Idioma: En Revista: Nucleic Acid Ther Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Suíça

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Oligonucleotídeos / Terapia Genética / Avaliação Pré-Clínica de Medicamentos Tipo de estudo: Guideline / Risk_factors_studies Limite: Humans Idioma: En Revista: Nucleic Acid Ther Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Suíça