148 results on '"Temple, Robert J."'
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2. Participation of Women in Clinical Trials Supporting FDA Approval of Cardiovascular Drugs
3. 2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials
4. Use of US Food and Drug Administration Expedited Drug Development and Review Programs by Orphan and Nonorphan Novel Drugs Approved From 2008 to 2021
5. 2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials
6. Opportunities for Integration of Pharmacokinetics, Pharmacodynamics and Toxicokinetics in Rational Drug Development
7. The Imperative of Overcoming Barriers to the Conduct of Large, Simple Trials
8. New FDA Regulation to Improve Safety Reporting in Clinical Trials
9. Farewell to our Wonderful Friend and Colleague, J. Richard (Dick) Crout (1929–2020)
10. Independent data monitoring committees: Preparing a path for the future
11. Speaker abstracts from ASENT 2004 Annual Meeting March 11–13, 2004
12. Enrichment Designs: Efficiency in Development of Cancer Treatments
13. Opportunities for Integration of Pharmacokinetics, Pharmacodynamics, and Toxicokinetics in Rational Drug Development
14. Homocysteine as a Predictive Factor for Hip Fracture in Older Persons
15. Choice of treatment: outcomes and treatment goals
16. Continued Need for Placebo in Many Cases, Even When There Is Effective Therapy
17. Implications of Effects in Placebo Groups
18. Therapeutic-class wars - drug promotion in a competitive marketplace
19. Postmarketing Surveillance and Black Box Warnings
20. Safety of Newly Approved Drugs : Implications for Prescribing
21. Farewell to our Wonderful Friend and Colleague, J. Richard (Dick) Crout (1929–2020).
22. Response to Monro and Mehta proposal for use of single-dose toxicology studies to support single-dose studies of new drugs in humans
23. Drug Promotion
24. Extracorporeal Shock-Wave Biliary Lithotripsy
25. 2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials
26. The US Food and Drug Administration’s Perspective on the New Antipsychotic Pimavanserin
27. The Devil Is Always in the Details
28. Summary of Findings From the FDA Regulatory Science Forum on Measuring Sexual Dysfunction in Depression Trials
29. Regulatory and Scientific Issues in Studies to Evaluate Sexual Dysfunction in Antidepressant Drug Trials
30. Report of the Workshop on Controlled-Release Dosage Forms: Issues and Controversies
31. The US Food and Drug Administration’s Perspective on the New Antidepressant Vortioxetine
32. Drug interactions: the death pen
33. Vilazodone
34. Bleeding Academic Research Consortium Consensus Report
35. Regulatory and Scientific Issues in Studies to Evaluate Sexual Dysfunction in Antidepressant Drug Trials.
36. The US Food and Drug Administration's Perspective on the New Antidepressant Vortioxetine.
37. Study Designs in Osteoporosis
38. Vitamin C Hypertension
39. Defining dose decrease
40. When are clinical trials of a given agent vs. placebo no longer appropriate or feasible?
41. Opportunities for Integration of Pharmacokinetics, Pharmacodynamics, and Toxicokinetics in Rational Drug Development
42. Guidance for development of chemopreventive agents
43. Special study designs: early escape, enrichment, studies in non-responders
44. Opportunities for Integration of Pharmacokinetics, Pharmacodynamics, and Toxicokinetics in Rational Drug Development
45. Opportunities for integration of pharmacokinetics, pharmacodynamics, and toxicokinetics in rational drug development
46. Vilazodone: Clinical Basis for the US Food and Drug Administration's Approval of a New Antidepressant.
47. The Regulatory Evolution of the Integrated Safety Summary
48. Access, Science, and Regulation
49. Letters.
50. THE EFFECT OF THE DRUG REGULATION REFORM ACT OF 1978 ON CLINICAL RESEARCH, DRUG AVAILABILITY, AND THE PUBLIC HEALTH.
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