The role of modeling and simulation in development and registration of medicinal products: Output from the efpia/ema modeling and simulation workshop

CPT: Pharmacometrics and Systems Pharmacology

Volumn 2, Issue 2, 2013, Pages

  Manolis, E ^a   Rohou, S ^b   Hemmings, R ^a,c   Salmonson, T ^a,d   Karlsson, M ^e   Milligan, P A ^f  

^a EUROPEAN MEDICINES AGENCY   (United Kingdom)

^b ASTRAZENECA   (United Kingdom)

^c MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY   (United Kingdom)

^d MEDICAL PRODUCTS AGENCY   (Sweden)

^e UPPSALA UNIVERSITY   (Sweden)

^f PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

PLANT MEDICINAL PRODUCT;

DOSE RESPONSE; DRUG INDUSTRY; DRUG LEGISLATION; DRUG MARKETING; DRUG RESEARCH; DRUG SYNTHESIS; EUROPE; HEALTH SERVICE; MODEL; PRIORITY JOURNAL; REVIEW; SIMULATION;

EID: 84878254933     PISSN: None     EISSN: 21638306     Source Type: Journal    
DOI: 10.1038/psp.2013.7     Document Type: Review

References (10)

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10. EMA draft Concept Paper on extrapolation of efficacy and safety in medicines development (2012). .