Improving the tools of clinical pharmacology: Goals for 2017 and beyond

Clinical Pharmacology and Therapeutics

Volumn 101, Issue 1, 2017, Pages 22-24

  Zineh, I ^a   Abernethy, D ^a   Hop, C E C A ^b   Bello, A ^c   McClellan, M B ^d   Daniel, G W ^d   Romine, M H ^d  

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

^b GENENTECH INC   (United States)

^c BRISTOL MYERS SQUIBB   (United States)

^d Health Policy Center   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL MARKER; PRESCRIPTION DRUG;

ARTICLE; CLINICAL PHARMACOLOGY; COMMERCIAL PHENOMENA; CULTURAL ANTHROPOLOGY; DRUG LEGISLATION; EXPERT SYSTEM; HUMAN; LEARNING; METHODOLOGY; MODEL; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROFESSIONAL STANDARD; QUANTITATIVE ANALYSIS; SOCIAL PARTICIPATION; DRUG APPROVAL; DRUG DESIGN; HEALTH CARE DELIVERY; MOTIVATION; TIME FACTOR; TRENDS;

DELIVERY OF HEALTH CARE; DRUG APPROVAL; DRUG DESIGN; GOALS; HUMANS; PHARMACOLOGY, CLINICAL; TIME FACTORS;

EID: 85006056656     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1002/cpt.530     Document Type: Article

References (8)

1. U.S. Food and Drug Administration. Novel drugs 2015 summary. (2016).
2. Pharmaprojects. Blockbuster Trends and Rising Stars of Global R&D. (2016).
3. KMR Group. Success Rates in Development: Large vs. Small Molecule Rates. (2015).
4. DiMasi, J.A., Grabowski, H.G. & Hansen, R.W. Innovation in the pharmaceutical industry: new estimates of R&D costs. J. Health Econ. 47, 20–33 (2016).
5. Tollman, P., Panier, V., Dosik, D., Biondi, P. & Cuss, F. Organizational effectiveness: a key to R&D productivity. Nat. Rev. Drug Discov. 15, 441–442 (2016).
6. EFPIA MID3 Workgroup et al. Good practices in model-informed drug discovery and development: practice, application, and documentation. CPT Pharmacometrics Syst. Pharmacol. 5, 93–122 (2016).
7. U.S. Food and Drug Administration. Guidance for industry: providing clinical evidence of effectiveness for human drug and biological products. (1998).
8. U.S. Food and Drug Administration. PDUFA reauthorization performance goals and procedures fiscal years 2018 through 2022. (2016).