The role of health-related quality of life data in the drug approval processes in the us and Europe: A review of guidance documents and authorizations of medicinal products from 2006 to 2010

Pharmaceutical Medicine

Volumn 25, Issue 3, 2011, Pages 147-160

  Marquis, Patrick ^a   Caron, Martine ^b   Emery, Marie Pierre ^b   Scott, Jane A ^c   Arnould, Benoit ^c   Acquadro, Catherine ^b  

^a Mapi Values USA LLC   (United States)

^b MAPI Research Trust   (France)

^c MAPI VALUES   (United States)

Author keywords

Clinical trial design; Endpoints; European Medicines Agency; Food and Drug Administration; Guideline utilisation; Labelling; Patient preference; Pharmaceutical industry; Product approvals; Product launches; Quality of life; Quality of life rating scales; Regulatory process

Indexed keywords

ANTINEOPLASTIC AGENT; APREPITANT; BICALUTAMIDE; BUDESONIDE PLUS FORMOTEROL; CARVEDILOL; ECULIZUMAB; FLUTICASONE FUROATE; FLUTICASONE PROPIONATE PLUS SALMETEROL XINAFOATE; FORMOTEROL FUMARATE PLUS MOMETASONE FUROATE; FOSAPREPITANT; GEFITINIB; GEMCITABINE; GOLIMUMAB; INTERFERON BETA SERINE; MELATONIN; NEW DRUG; PAZOPANIB; PRUCALOPRIDE; QUETIAPINE; RECOMBINANT ERYTHROPOIETIN; TRABECTEDIN; USTEKINUMAB; VARENICLINE;

ALLERGIC RHINITIS; ANEMIA; ANKYLOSING SPONDYLITIS; ASTHMA; BIPOLAR DISORDER; CHEMOTHERAPY INDUCED EMESIS; CHRONIC OBSTRUCTIVE LUNG DISEASE; CLINICAL EFFECTIVENESS; CLINICAL TRIAL (TOPIC); CONSTIPATION; CYSTIC FIBROSIS; DATA ANALYSIS; DRUG APPROVAL; DRUG LABELING; DRUG SAFETY; EUROPE; EUROPEAN MEDICINES AGENCY; FOOD AND DRUG ADMINISTRATION; HAY FEVER; HEALTH CARE ORGANIZATION; HEART FAILURE; HEMATOLOGIC MALIGNANCY; HUMAN; INSOMNIA; KIDNEY CARCINOMA; LUNG NON SMALL CELL CANCER; MULTIPLE SCLEROSIS; OUTCOME ASSESSMENT; OVARY TUMOR; PAROXYSMAL NOCTURNAL HEMOGLOBINURIA; PERENNIAL RHINITIS; PRACTICE GUIDELINE; PRESCRIPTION; PRIORITY JOURNAL; PROSTATE TUMOR; PSORIASIS; PSORIATIC ARTHRITIS; QUALITY OF LIFE; REVIEW; RHEUMATOID ARTHRITIS; SYSTEMATIC REVIEW; TOBACCO DEPENDENCE; TREATMENT INDICATION; UNITED STATES; WEIGHT CONTROL;

EID: 79960017594     PISSN: 11782595     EISSN: 11791993     Source Type: Journal    
DOI: 10.2165/11588560-000000000-00000     Document Type: Review

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