Scientific and Regulatory Policy Committee Points to Consider: Nonclinical Research and Development of In Vivo Gene Therapy Products, Emphasizing Adeno-Associated Virus Vectors.

Hutt, Julie A; Assaf, Basel T; Bolon, Brad; Cavagnaro, Joy; Galbreath, Elizabeth; Grubor, Branka; Kattenhorn, Lisa M; Romeike, Annette; Whiteley, Laurence O

Hutt, Julie A; Assaf, Basel T; Bolon, Brad; Cavagnaro, Joy; Galbreath, Elizabeth; Grubor, Branka; Kattenhorn, Lisa M; Romeike, Annette; Whiteley, Laurence O.

Afiliación

Hutt JA; Greenfield Pathology Services, Inc, Greenfield, IN, USA.
Assaf BT; Drug Safety Research and Development, 2253Pfizer Inc, Cambridge, MA, USA.
Bolon B; GEMpath, Inc, Longmont, CO, USA.
Cavagnaro J; Access BIO, Boyce, VA, USA.
Galbreath E; Takeda US, Inc, Cambridge, MA, USA.
Grubor B; 2191Biogen, Preclinical Safety/Comparative Pathology, Cambridge, MA, USA.
Kattenhorn LM; Cambridge, MA, USA.
Romeike A; Covance Preclinical Services GmbH, Münster, Germany.
Whiteley LO; Drug Safety Research and Development, 2253Pfizer Inc, Cambridge, MA, USA.

Toxicol Pathol ; 50(1): 118-146, 2022 01.

Article en En | MEDLINE | ID: mdl-34657529

Asunto(s)

Dependovirus; Terapia Genética; Dependovirus/genética; Terapia Genética/métodos; Humanos; Políticas; Investigación

Palabras clave

AAV; gene therapy; nonclinical toxicity; safety assessment; viral vector

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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Terapia Genética / Dependovirus Tipo de estudio: Guideline / Prognostic_studies / Risk_factors_studies Límite: Humans Idioma: En Revista: Toxicol Pathol Año: 2022 Tipo del documento: Article País de afiliación: Estados Unidos

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