Contribution of modeling and simulation in the regulatory review and decision-making: U.S. FDA perspective

AAPS Advances in the Pharmaceutical Sciences Series

Volumn 2011, Issue 1, 2011, Pages 37-57

  Garnett, Christine E ^a   Lee, Joo Yeon ^a   Gobburu, Jogarao V S ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; APOMORPHINE; ARGATROBAN; ARGATROBAN INJECTION; BUSULFAN; CANAKINUMAB; CELECOXIB; CERTOLIZUMAB PEGOL; CLEVIDIPINE; DIGOXIN; EVEROLIMUS; FENOLDOPAM MESILATE; LEVOCETIRIZINE; LEVOFLOXACIN; LOVAQUIN; MICAFUNGIN; NESIRITIDE; OXCARBAZEPINE; PARICALCITOL; PIPERACILLIN PLUS TAZOBACTAM; SOTALOL; TETRABENAZINE; UNCLASSIFIED DRUG; VARENICLINE; ZOLEDRONIC ACID; CANDESARTAN HEXETIL; HEPARIN; LAMOTRIGINE; METOPROLOL SUCCINATE; MOXIFLOXACIN; PLACEBO; QUETIAPINE; RANOLAZINE; SILDENAFIL; UNINDEXED DRUG;

ABDOMINAL INFECTION; ARTICLE; BONE METASTASIS; CHRONIC MYELOID LEUKEMIA; CLINICAL PROTOCOL; CLINICAL TRIAL (TOPIC); CROHN DISEASE; DECISION MAKING; DRUG APPROVAL; DRUG DEVELOPMENT; DRUG DOSE; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG DOSE TITRATION; DRUG INDICATION; DRUG LABELING; DRUG RESEARCH; DRUG SAFETY; EPILEPSY; ESOPHAGUS CANDIDIASIS; FOOD AND DRUG ADMINISTRATION; GRAFT REJECTION; HEART ARRHYTHMIA; HEART FAILURE; HUMAN; HUNTINGTON CHOREA; HYPERCALCEMIA; HYPERPARATHYROIDISM; HYPERTENSION; JUVENILE RHEUMATOID ARTHRITIS; LOADING DRUG DOSE; MATHEMATICAL MODEL; PARKINSON DISEASE; PEDIATRICS; PHARMACEUTICS; PHARMACOMETRICS; PRIORITY JOURNAL; RECOMMENDED DRUG DOSE; RHEUMATOID ARTHRITIS; RISK BENEFIT ANALYSIS; SIMULATION; STUDY DESIGN; UNITED STATES; UNSPECIFIED SIDE EFFECT; ACUTE HEART INFARCTION; ANGINA PECTORIS; BIPOLAR DISORDER; CARDIAC GRAFT REJECTION; CHRONIC KIDNEY DISEASE; DOSE RESPONSE; DRUG BIOAVAILABILITY; DRUG EFFICACY; DRUG EXPOSURE; DRUG FORMULATION; DRUG INFORMATION; DRUG LEGISLATION; DRUG MEGADOSE; DRUG RESPONSE; DRUG SCREENING; DRUG TOLERABILITY; KIDNEY GRAFT REJECTION; LOW DRUG DOSE; LUNG NON SMALL CELL CANCER; MAXIMUM PLASMA CONCENTRATION; METHODOLOGY; NONHUMAN; PHARMACODYNAMICS; PHARMACOKINETICS; PHARMACOLOGICAL PARAMETERS; PILOT STUDY; PRACTICE GUIDELINE; PROGRAM DEVELOPMENT; PUBLICATION; PULMONARY HYPERTENSION; QT PROLONGATION; REVIEW; SCHIZOPHRENIA; SEIZURE;

EID: 85081146044     PISSN: 22107371     EISSN: 2210738X     Source Type: Book Series    
DOI: 10.1007/978-1-4419-7415-0_3     Document Type: Article

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