Paediatric drug development: The impact of evolving regulations

Advanced Drug Delivery Reviews

Volumn 73, Issue , 2014, Pages 2-13

  Turner, M A ^a   Catapano, M ^b   Hirschfeld, S ^c   Giaquinto, C ^d  

^a UNIVERSITY OF LIVERPOOL   (United Kingdom)

^b UNIVERSITY OF PAVIA   (Italy)

^c EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT   (United States)

^d UNIVERSITY HOSPITAL OF PADOVA   (Italy)

Author keywords

Children's medicine; Extrapolation; Pharmaceutical development; Pharmacodynamics; Pharmacokinetics; Regulatory framework; Risk benefit ratio

Indexed keywords

EXTRAPOLATION; LAWS AND LEGISLATION; PHARMACODYNAMICS; PHARMACOKINETICS; PEDIATRICS;

DRUG DEVELOPMENT; DRUG DEVELOPMENT PIPELINE; LEGAL AND REGULATORY FRAMEWORKS; PHARMACEUTICAL DEVELOPMENT; PROOF OF CONCEPT; REGULATORY FRAMEWORKS; RISK BENEFITS;

PEDIATRICS; LAWS AND LEGISLATION;

CLINICAL DEVELOPMENT PLAN; DRUG LEGISLATION; DRUG RESEARCH; ECONOMIC DEVELOPMENT; ETHICS; EUROPEAN UNION; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; HUMAN; JUVENILE ANIMAL; NEEDS ASSESSMENT; NONHUMAN; PATENT; POSTMARKETING SURVEILLANCE; PRACTICE GUIDELINE; PRIORITY JOURNAL; REVIEW; UNITED STATES; CHILD SAFETY; CONTROLLED CLINICAL TRIAL (TOPIC); COUGHING; DRUG CONTROL; DRUG DEVELOPMENT; DRUG FORMULATION; DRUG INDUSTRY; DRUG QUALITY; DRUG SAFETY; DRUG SCREENING; ECONOMIC EVALUATION; EUROPE; EXPERIMENTAL ANIMAL; MEDICAL EDUCATION; MEDICAL ETHICS; NEWBORN CARE; PEDIATRICS; RISK BENEFIT ANALYSIS; SYSTEMATIC REVIEW (TOPIC); UNSPECIFIED SIDE EFFECT; ANIMAL; CHILD; LEGISLATION AND JURISPRUDENCE;

ANGIOTENSIN RECEPTOR ANTAGONIST; BETA ADRENERGIC RECEPTOR STIMULATING AGENT; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; STEROID; THALIDOMIDE;

ANIMALS; CHILD; DRUG DISCOVERY; EUROPEAN UNION; HUMANS; LEGISLATION, DRUG; PEDIATRICS; UNITED STATES;

EID: 84902316651     PISSN: 0169409X     EISSN: 18728294     Source Type: Journal    
DOI: 10.1016/j.addr.2014.02.003     Document Type: Review

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