From molecule to market access: Drug regulatory science as an upcoming discipline

European Journal of Pharmacology

Volumn 719, Issue 1-3, 2013, Pages 9-15

  Gispen De Wied, Christine C ^a   Leufkens, Hubertus G M ^a  

^a MEDICINES EVALUATION BOARD   (Netherlands)

Author keywords

Benefit risk assessment; Drug development; Market authorization; Post marketing surveillance; Regulatory science

Indexed keywords

GENERIC DRUG; NEW DRUG; VACCINE;

ARTICLE; COST EFFECTIVENESS ANALYSIS; DECISION MAKING; DRUG APPROVAL; DRUG EFFICACY; DRUG MARKETING; DRUG REGULATORY SCIENCE; DRUG SAFETY; EVIDENCE BASED PRACTICE; FOOD AND DRUG ADMINISTRATION; HUMAN; LICENSING; NONHUMAN; PRIORITY JOURNAL; PUBLIC HEALTH; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; SCIENCE; STANDARD; VALIDATION STUDY;

BENEFIT-RISK ASSESSMENT; DRUG DEVELOPMENT; MARKET AUTHORIZATION; POST-MARKETING SURVEILLANCE; REGULATORY SCIENCE;

ANIMALS; EVIDENCE-BASED PRACTICE; GOVERNMENT AGENCIES; HUMANS; PHARMACEUTICAL PREPARATIONS; SAFETY; SOCIAL CONTROL, FORMAL;

EID: 84888288345     PISSN: 00142999     EISSN: 18790712     Source Type: Journal    
DOI: 10.1016/j.ejphar.2013.07.021     Document Type: Review

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