ライフサイエンスコーパス: postmarketing

1 imentary data sources may permit more timely postmarketing assessment of vaccine safety.

2 Administration has received reports of five postmarketing cases of severe liver disease that resulte

3 f a phase IV US Food and Drug Administration postmarketing commitment.

4 celerated review, advisory committee review, postmarketing commitments).

5 Analysis of real-world, postmarketing data has limitations, and these findings s

6 rveillance system that collects and analyzes postmarketing data on misuse and diversion of prescripti

7 This study provides additional postmarketing data that mefloquine does not cause gross

8 port for independent reviews and analysis of postmarketing data.

9 The postmarketing database of the US Food and Drug Administr

10 fentanil is still in its infancy in terms of postmarketing development.

11 during long-term administration, leading to postmarketing dose optimization studies to re-evaluate t

12 Since there is no correlate of protection, a postmarketing effectiveness study is required to determi

13 ovide an excellent, inexpensive resource for postmarketing evaluation of rheumatologic medications.

14 linical trial program combined with 5 years' postmarketing experience with valacyclovir provides evid

15 omes (ZODIAC) was an open-label, randomized, postmarketing large simple trial that enrolled patients

16 EXCELS, a postmarketing observational cohort study, was a commitme

17 nformation will inevitably be learned in the postmarketing period about the safety of medicines and h

18 ly represented in pharmacology research, and postmarketing pharmacovigilance activities tend to be ru

19 investigators during the planning stage of a postmarketing phase 4 RCT dedicated to the evaluation of

20 acturer of the drug in question to conduct a postmarketing (phase 4) randomized controlled trial (RCT

21 These domains encompass both the pre- and postmarketing phases of drug research.

22 This study was undertaken to investigate postmarketing reports of malignancy in children treated

23 understood, has been the subject of ongoing postmarketing reports.

24 the basis of premarketing studies and a few postmarketing reports.

25 ies was extracted from the FDA's database of postmarketing requirements and commitments, ClinicalTria

26 r magnitude and a better infrastructure than postmarketing research, yet issues arising in the two ph

27 could greatly enhance the infrastructure of postmarketing research.

28 Specific compliance and postmarketing safety issues (especially liver enzyme mon

29 meetings included voting questions regarding postmarketing safety or trial design).

30 dlines were associated with a higher rate of postmarketing safety problems (e.g., withdrawals and bla

31 e whether the deadlines were associated with postmarketing safety problems, we focused on drugs submi

32 The FDA web site was searched for postmarketing safety reviews, and the FDA was contacted

33 Rates reported in the postmarketing setting are comparable.

34 reated MS patients diagnosed with PML in the postmarketing setting were identified, of whom 22 (10 wi

35 ontinued monitoring of adverse events in the postmarketing setting will provide additional informatio

36 In the postmarketing setting, all patients received fingolimod,

37 In the postmarketing setting, reporting rates since 2010 were e

38 ting of adverse events in the trials and the postmarketing setting.

39 Rates reported in the postmarketing settings were comparable (7 per 1000 patie

40 We used data from postmarketing sources, clinical studies, and an independ

41 tients from natalizumab clinical studies and postmarketing sources.

42 monstrated the need for well-designed, valid postmarketing studies of medical devices.

43 Postmarketing studies suggest that the favorable results

44 lizumab, along with the lessons learned from postmarketing studies.

45 ministration mandated that companies conduct postmarketing surveillance (PMS) studies of approved ste

46 Proactive postmarketing surveillance and further studies are pivot

47 lestra (sucrose polyester) called for active postmarketing surveillance because preapproval studies s

48 The ASRS TSC encourages active postmarketing surveillance by all physicians.

49 r examining the available literature and the postmarketing surveillance data, proposed a clinically b

50 in prescribing this drug pending additional postmarketing surveillance data.

51 Examination of the FDA postmarketing surveillance databases revealed a low repo

52 Longer-term clinical trials and careful postmarketing surveillance during the next several decad

53 Careful postmarketing surveillance for adverse effects, especial

54 f monitoring both pharmaceutical quality and postmarketing surveillance for adverse events.

55 recent studies have examined how frequently postmarketing surveillance identifies important ADRs.

56 Postmarketing surveillance indicates that the diversion

57 However, longer-term trial results and postmarketing surveillance of major adverse events will

58 ition, observational studies can be used for postmarketing surveillance of new cancer treatments, par

59 ing and documenting adverse effects; and (8) postmarketing surveillance of therapy outcomes.

60 Additional postmarketing surveillance of these and other serious ad

61 (VAERS) is the passive reporting system for postmarketing surveillance of vaccine safety in the Unit

62 Postmarketing surveillance revealed a potential serious

63 and the importance of internationally robust postmarketing surveillance strategies as crucial compone

64 n the near future, with a call for effective postmarketing surveillance studies for all of the new en

65 This active postmarketing surveillance study of a food additive sugg

66 that the agency's drug review procedures and postmarketing surveillance system after a drug has been

67 This study demonstrates the power of active postmarketing surveillance to identify or exclude events

68 authorisation procedures mandated increased postmarketing surveillance to monitor vaccine safety.

69 data submitted to Merck from routine global postmarketing surveillance, combined with information fr

70 se complications will likely require careful postmarketing surveillance.

71 reported to Merck, the manufacturer, through postmarketing surveillance.

72 arly detection has largely shifted to the US postmarketing systems.

73 Results of premarketing and postmarketing trials have raised doubts about the cardio

74 Recent postmarketing trials produced conflicting results about

75 program must verify the clinical benefit in postmarketing trials.

76 Thus, postmarketing vaccine safety assessments are necessary.