The regulatory framework for similar biotherapeutic products in Cuba

Biologicals

Volumn 39, Issue 5, 2011, Pages 317-320

  Hechavarria Núnez, Yanet ^a   Pérez Massipe, Rodrigo Omar ^a   Orta Hernández, Santa Deybis ^a   Muñoz, Lázara Martínez ^a   Jacobo Casanueva, Olga Lidia ^a   Pérez Rodríguez, Violeta ^a   Domínguez Morales, Rolando Bárbaro ^a   Pérez Cristiá, Rafael B ^a  

^a Centro para el Control Estatal de la Calidad de los Medicamentos (CECMED)   (Cuba)

Author keywords

CECMED; Known biological product; Polo Cient fico del Oeste de La Habana; Similar biotherapeutic product

Indexed keywords

BIOLOGICAL PRODUCT;

ARTICLE; CUBA; DRUG APPROVAL; DRUG INDUSTRY; DRUG INFORMATION; DRUG LEGISLATION; DRUG MANUFACTURE; DRUG MARKETING; DRUG RESEARCH; HEALTH CARE ORGANIZATION; HEALTH CARE SYSTEM; LICENCE; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUALITY CONTROL;

CUBA; DRUG INDUSTRY; GUIDELINES AS TOPIC; HUMANS; LEGISLATION, DRUG; NATIONAL HEALTH PROGRAMS; PHARMACEUTICAL PREPARATIONS; QUALITY CONTROL;

EID: 80053561994     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2011.08.005     Document Type: Article

References (10)

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