Found: 61
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Cytomatrix synthesis in MDCK epithelial cells.
- Published in:
- Journal of Cellular Physiology, 1990, v. 143, n. 3, p. 501, doi. 10.1002/jcp.1041430315
- By:
- Publication type:
- Article
Inhibition of calcium and glucose uptake by murine leukemia L5178Y cells treated with antiserum.
- Published in:
- Journal of Cellular Physiology, 1980, v. 105, n. 3, p. 423, doi. 10.1002/jcp.1041050306
- By:
- Publication type:
- Article
Regulatory watch: What drives differences in review times among CDER divisions?
- Published in:
- 2015
- By:
- Publication type:
- journal article
Paving the critical path of drug development: the CDER perspective.
- Published in:
- Nature Reviews Drug Discovery, 2014, v. 13, n. 11, p. 783, doi. 10.1038/nrd4435
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- Publication type:
- Article
The driving role of consortia on the critical path to innovative therapies.
- Published in:
- Nature Reviews Drug Discovery, 2014, v. 13, n. 11, p. 781, doi. 10.1038/nrd4462
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- Publication type:
- Article
Biomarkers for Alzheimer's disease: academic, industry and regulatory perspectives.
- Published in:
- 2010
- By:
- Publication type:
- journal article
Transporters in drug development: advancing on the Critical Path.
- Published in:
- Nature Reviews Drug Discovery, 2010, v. 9, n. 3, p. 175, doi. 10.1038/nrd3124
- By:
- Publication type:
- Article
Stimulating the development of mechanism-based, individualized pain therapies.
- Published in:
- 2007
- By:
- Publication type:
- review
The FDA's assessment of follow-on protein products: a historical perspective.
- Published in:
- 2007
- By:
- Publication type:
- review
Opinion: Translation of pharmacogenomics and pharmacogenetics: a regulatory perspective.
- Published in:
- Nature Reviews Drug Discovery, 2004, v. 3, n. 9, p. 763, doi. 10.1038/nrd1499
- By:
- Publication type:
- Article
Benefits of Streamlined Point-of-Care Trial Designs: Lessons Learned From the UK RECOVERY Study.
- Published in:
- 2022
- By:
- Publication type:
- journal article
Integrated Drug Reviews at the US Food and Drug Administration.
- Published in:
- 2020
- By:
- Publication type:
- Letter
Improving Adverse Event Reporting for Compounded Drugs.
- Published in:
- 2019
- By:
- Publication type:
- journal article
Drug Trials Snapshots and Sexless Drug Labels-Reply.
- Published in:
- 2017
- By:
- Publication type:
- journal article
Review of the Drug Trials Snapshots Program of the US Food and Drug Administration: Women in Cardiovascular Drug Trials.
- Published in:
- 2017
- By:
- Publication type:
- journal article
The Safety of Newly Approved Medicines.
- Published in:
- JAMA: Journal of the American Medical Association, 1999, v. 281, n. 18, p. 1728, doi. 10.1001/jama.281.18.1728
- By:
- Publication type:
- Article
MAQC and the era of genomic medicine.
- Published in:
- Nature Biotechnology, 2021, v. 39, n. 9, p. 1066, doi. 10.1038/s41587-021-01050-y
- By:
- Publication type:
- Article
The US regulatory and pharmacopeia response to the global heparin contamination crisis.
- Published in:
- Nature Biotechnology, 2016, v. 34, n. 6, p. 625, doi. 10.1038/nbt.3606
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- Publication type:
- Article
Scientific considerations in the review and approval of generic enoxaparin in the United States.
- Published in:
- Nature Biotechnology, 2013, v. 31, n. 3, p. 220, doi. 10.1038/nbt.2528
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- Publication type:
- Article
Research at the interface of industry, academia and regulatory science.
- Published in:
- Nature Biotechnology, 2010, v. 28, n. 5, p. 432, doi. 10.1038/nbt0510-432
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- Publication type:
- Article
Oversulfated chondroitin sulfate is a contaminant in heparin associated with adverse clinical events.
- Published in:
- Nature Biotechnology, 2008, v. 26, n. 6, p. 669, doi. 10.1038/nbt1407
- By:
- Publication type:
- Article
Empowering microarrays in the regulatory setting.
- Published in:
- Nature Biotechnology, 2006, v. 24, p. 1103, doi. 10.1038/nbt0906-1103
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- Publication type:
- Article
Empowering microarrays in the regulatory setting.
- Published in:
- Nature Biotechnology, 2006, v. 24, n. 9, p. 1103, doi. 10.1038/nbt0906-1103
- By:
- Publication type:
- Article
A regulatory perspective on in vitro diagnostics.
- Published in:
- 2006
- By:
- Publication type:
- Editorial
Medical applications of microarray technologies: a regulatory science perspective.
- Published in:
- Nature Genetics, 2002, v. 32, p. 474, doi. 10.1038/ng1029
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- Publication type:
- Article
Understanding Pharmaceutical Quality by Design.
- Published in:
- AAPS Journal, 2014, v. 16, n. 4, p. 771, doi. 10.1208/s12248-014-9598-3
- By:
- Publication type:
- Article
Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework<sup>*</sup>.
- Published in:
- Clinical Pharmacology & Therapeutics, 2001, v. 69, n. 3, p. 89, doi. 10.1067/mcp.2001.113989
- By:
- Publication type:
- Article
Update on and Future Directions for Use of Anti-SARS-CoV-2 Antibodies: National Institutes of Health Summit on Treatment and Prevention of COVID-19.
- Published in:
- 2022
- By:
- Publication type:
- journal article
Grand Challenges for Psychiatric Drug Discovery: A Perspective.
- Published in:
- Neuropsychopharmacology, 2008, v. 33, n. 10, p. 2047, doi. 10.1038/npp.2008.54
- By:
- Publication type:
- Article
Medication development in opioid addiction: Meaningful clinical end points.
- Published in:
- Science Translational Medicine, 2018, v. 10, n. 434, p. 1, doi. 10.1126/scitranslmed.aan2595
- By:
- Publication type:
- Article
Immune-mediated pathology in Duchenne muscular dystrophy.
- Published in:
- Science Translational Medicine, 2015, v. 7, n. 299, p. 1, doi. 10.1126/scitranslmed.aaa7322
- By:
- Publication type:
- Article
Riposte: FDA response to 'Yin, yang and the biopharmaceutical industry'
- Published in:
- Journal of Commercial Biotechnology, 2003, v. 10, n. 1, p. 36, doi. 10.1057/palgrave.jcb.3040053
- By:
- Publication type:
- Article
Using a Benefit–Risk Analysis Approach to Capture Regulatory Decision Making: Renal Cell Carcinoma.
- Published in:
- Clinical Pharmacology & Therapeutics, 2020, v. 107, n. 3, p. 495, doi. 10.1002/cpt.1589
- By:
- Publication type:
- Article
Using a Benefit–Risk Analysis Approach to Capture Regulatory Decision Making: Melanoma.
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 123, doi. 10.1002/cpt.1461
- By:
- Publication type:
- Article
Considerations for Developing Targeted Therapies in Low‐Frequency Molecular Subsets of a Disease.
- Published in:
- Clinical Pharmacology & Therapeutics, 2018, v. 104, n. 2, p. 282, doi. 10.1002/cpt.1041
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- Publication type:
- Article
The FDA's Approach to the Prescription Opioid Problem.
- Published in:
- Clinical Pharmacology & Therapeutics, 2018, v. 103, n. 6, p. 954, doi. 10.1002/cpt.1055
- By:
- Publication type:
- Article
A Benefit-Risk Analysis Approach to Capture Regulatory Decision-Making: Multiple Myeloma.
- Published in:
- Clinical Pharmacology & Therapeutics, 2018, v. 103, n. 1, p. 67, doi. 10.1002/cpt.871
- By:
- Publication type:
- Article
COVID-19 Vaccination-Becoming Part of the New Normal.
- Published in:
- JAMA: Journal of the American Medical Association, 2022, v. 327, n. 19, p. 1863, doi. 10.1001/jama.2022.7469
- By:
- Publication type:
- Article
Racial and Ethnic Representation of Participants in US Clinical Trials of New Drugs and Biologics—Reply.
- Published in:
- 2022
- By:
- Publication type:
- Letter to the Editor
Racial and Ethnic Representation in US Clinical Trials of New Drugs and Biologics, 2015-2019.
- Published in:
- JAMA: Journal of the American Medical Association, 2021, v. 326, n. 21, p. 2201, doi. 10.1001/jama.2021.16680
- By:
- Publication type:
- Article
Reducing Sodium Intake in the US: Healthier Lives, Healthier Future.
- Published in:
- JAMA: Journal of the American Medical Association, 2021, v. 326, n. 17, p. 1675, doi. 10.1001/jama.2021.18611
- By:
- Publication type:
- Article
Real-World Evidence and Real-World Data for Evaluating Drug Safety and Effectiveness.
- Published in:
- 2018
- By:
- Publication type:
- journal article
Multidimensional Evidence Generation and FDA Regulatory Decision Making: Defining and Using "Real-World" Data.
- Published in:
- 2017
- By:
- Publication type:
- journal article
Marshaling FDA Benefit-Risk Expertise to Address the Current Opioid Abuse Epidemic.
- Published in:
- 2017
- By:
- Publication type:
- journal article
American College of Clinical Pharmacology 33rd Annual Meeting Preliminary Program.
- Published in:
- Journal of Clinical Pharmacology, 2004, v. 44, n. 7, p. 8021
- By:
- Publication type:
- Article
Keratin Classes: Molecular Markers for Different Types of Epithelial Differentiation.
- Published in:
- Journal of Investigative Dermatology, 1983, v. 81, p. 109s, doi. 10.1111/1523-1747.ep12540831
- By:
- Publication type:
- Article
The US Food and Drug Administration's Sentinel Initiative: Expanding the horizons of medical product safety.
- Published in:
- Pharmacoepidemiology & Drug Safety, 2012, v. 21, p. 9, doi. 10.1002/pds.2311
- By:
- Publication type:
- Article
Quality Testing of Difficult-to-Make Prescription Pharmaceutical Products Marketed in the US.
- Published in:
- JAMA Network Open, 2020, v. 3, n. 8, p. e2013920, doi. 10.1001/jamanetworkopen.2020.13920
- By:
- Publication type:
- Article
Critical Path Initiative: A Conversation with Janet Woodcock, MD.
- Published in:
- Applied Clinical Trials, 2005, v. 14, n. 9, p. 53
- By:
- Publication type:
- Article
The Role of the U.S. Food and Drug Administration Review Process: Clinical Trial Endpoints in Oncology.
- Published in:
- Oncologist, 2010, v. 15, p. 13, doi. 10.1634/theoncologist.2010-S1-13
- By:
- Publication type:
- Article