Pharmaceutical industry perspective on risk evaluation and mitigation strategies: Manufacturer take heed

Expert Opinion on Drug Safety

Volumn 11, Issue 2, 2012, Pages 299-314

  Nicholson, Susan ^a   Peterson, Janet ^a   Yektashenas, Behin ^a  

^a JANSSEN RESEARCH AND DEVELOPMENT   (United States)

Author keywords

Pharmaceutical industry; Risk management; Safety; United States Food and Drug Administration

Indexed keywords

4 AMINOPYRIDINE; ALVIMOPAN; ARFORMOTEROL; BOTULINUM TOXIN A; BUPRENORPHINE; CARBAMAZEPINE; DEXTROPROPOXYPHENE; DEXTROPROPOXYPHENE NAPSILATE; FENTANYL; FENTANYL CITRATE; FLUTICASONE PROPIONATE PLUS SALMETEROL; FLUTICASONE PROPIONATE PLUS SALMETEROL XINAFOATE; FORMOTEROL FUMARATE; FORMOTEROL FUMARATE PLUS MOMETASONE FUROATE; GLIMEPIRIDE PLUS PIOGLITAZONE; GLIMEPIRIDE PLUS ROSIGLITAZONE; HYDROMORPHONE; INDACATEROL; METFORMIN PLUS PIOGLITAZONE; METFORMIN PLUS ROSIGLITAZONE; MORPHINE SULFATE PLUS NALTREXONE; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; PIOGLITAZONE; PRASUGREL; RECOMBINANT ERYTHROPOIETIN; ROSIGLITAZONE; TESTOSTERONE; TIAGABINE; TICAGRELOR; TOCILIZUMAB; UNINDEXED DRUG; VANDETANIB; VARENICLINE;

ANEMIA; ASTHMA; BIPOLAR DISORDER; BLEPHAROSPASM; BRONCHOSPASM; CERVICAL DYSTONIA; CHRONIC OBSTRUCTIVE LUNG DISEASE; CLINICAL ASSESSMENT TOOL; DIABETES MELLITUS; DRUG APPROVAL; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HUMAN; HYPERHIDROSIS; MULTIPLE SCLEROSIS; PAIN; PRACTICE GUIDELINE; REVIEW; RHEUMATOID ARTHRITIS; RISK ASSESSMENT; RISK EVALUATION AND MITIGATION STRATEGY; RISK MANAGEMENT; SEIZURE; STRABISMUS; THYROID CANCER; UNITED STATES;

CONSUMER PRODUCT SAFETY; DRUG APPROVAL; DRUG INDUSTRY; GOVERNMENT REGULATION; HUMANS; PHARMACEUTICAL PREPARATIONS; PRODUCT SURVEILLANCE, POSTMARKETING; RISK ASSESSMENT; RISK FACTORS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84857422648     PISSN: 14740338     EISSN: 1744764X     Source Type: Journal    
DOI: 10.1517/14740338.2012.650689     Document Type: Review

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