Contribution of modeling and simulation studies in the regulatory review: A european regulatory perspective

AAPS Advances in the Pharmaceutical Sciences Series

Volumn 2011, Issue 1, 2011, Pages 15-36

  Jönsson, Siv ^a   Henningsson, Anja ^a   Edholm, Monica ^a   Salmonson, Tomas ^a  

^a MEDICAL PRODUCTS AGENCY   (Sweden)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIRETROVIRUS AGENT; ETIRACETAM; MARAVIROC; SUGAMMADEX;

ARTICLE; CLINICAL TRIAL (TOPIC); COMPARTMENT MODEL; DECISION MAKING; DOCUMENTATION; DRUG APPROVAL; DRUG DEVELOPMENT; DRUG MARKETING; DRUG RESEARCH; DRUG RESPONSE; EUROPE; GOVERNMENT; HEALTH CARE ORGANIZATION; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; LAW; MATHEMATICAL MODEL; PHARMACODYNAMICS; PHARMACOKINETICS; PRACTICE GUIDELINE; PRIORITY JOURNAL; RECOMMENDED DRUG DOSE; SEIZURE; SIMULATION; STUDY DESIGN; SWEDEN; AWARENESS; BINDING AFFINITY; BINDING SITE; DATA ANALYSIS; DOSE RESPONSE; DRUG ABSORPTION; DRUG BINDING; DRUG BIOAVAILABILITY; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG EFFICACY; DRUG INDUSTRY; DRUG POTENTIATION; FOOD; FOOD DRUG INTERACTION; GOVERNMENT REGULATION; GROUPS BY AGE; INTROSPECTION; LEGAL ASPECT; MEDICAL DOCUMENTATION; MEDICAL INFORMATION; ORGANIZATIONAL DOWNSIZING; ORGANIZATIONAL EFFICIENCY; PATIENT ASSESSMENT; REVIEW;

EID: 84873062250     PISSN: 22107371     EISSN: 2210738X     Source Type: Book Series    
DOI: 10.1007/978-1-4419-7415-0_2     Document Type: Article

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