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1    Reporting of adverse events is a critical postmarketing activity.
2 the United States and Germany and cumulative postmarketing adverse event data from 61,499 pwCF who in
3 lements a novel pattern discovery method for postmarketing adverse event identification, named Modifi
4 neration for idelalisib during premarketing, postmarketing, and premarketing withdrawal periods.
5           The scientific community relies on postmarketing approaches to define the risk of using med
6 imentary data sources may permit more timely postmarketing assessment of vaccine safety.
7  Administration has received reports of five postmarketing cases of severe liver disease that resulte
8 of demographic subgroups in premarketing and postmarketing clinical studies is necessary for understa
9 f a phase IV US Food and Drug Administration postmarketing commitment.
10 celerated review, advisory committee review, postmarketing commitments).
11 s the prevalence and factors associated with postmarketing communications by the US Food and Drug Adm
12 e approved through the latter pathway, where postmarketing confirmatory studies are typically not req
13  design (TND) has been widely used to assess postmarketing COVID-19 vaccine effectiveness but require
14                      Analysis of real-world, postmarketing data has limitations, and these findings s
15 rveillance system that collects and analyzes postmarketing data on misuse and diversion of prescripti
16               This study provides additional postmarketing data that mefloquine does not cause gross
17                        This case series uses postmarketing data to evaluate the association of daratu
18 se events (AEs) among anti-VEGF agents using postmarketing data.
19 port for independent reviews and analysis of postmarketing data.
20                                          The postmarketing database of the US Food and Drug Administr
21 fentanil is still in its infancy in terms of postmarketing development.
22 ggest that clinical data can be used for the postmarketing device surveillance required by the FDA.
23  during long-term administration, leading to postmarketing dose optimization studies to re-evaluate t
24 Since there is no correlate of protection, a postmarketing effectiveness study is required to determi
25                                   Subsequent postmarketing efficacy data against these organisms are
26 ed accelerated approval, which would mandate postmarketing efficacy studies.
27 ovide an excellent, inexpensive resource for postmarketing evaluation of rheumatologic medications.
28                                              Postmarketing evaluations have linked myocarditis to COV
29 linical trial program combined with 5 years' postmarketing experience with valacyclovir provides evid
30 omes (ZODIAC) was an open-label, randomized, postmarketing large simple trial that enrolled patients
31 itional until regulator-imposed confirmatory postmarketing measures are fulfilled.
32                                    Continued postmarketing monitoring is warranted to define evolving
33 ed in phase 2 and 3 trials as well as during postmarketing monitoring trials.
34                                    EXCELS, a postmarketing observational cohort study, was a commitme
35 nformation will inevitably be learned in the postmarketing period about the safety of medicines and h
36                               By the initial postmarketing period, the cumulative RR for SAEs was 1.8
37 ly represented in pharmacology research, and postmarketing pharmacovigilance activities tend to be ru
38 fety risk was identified; however additional postmarketing pharmacovigilance is ongoing.
39                                  To date, no postmarketing pharmacovigilance study has comprehensivel
40 investigators during the planning stage of a postmarketing phase 4 RCT dedicated to the evaluation of
41 acturer of the drug in question to conduct a postmarketing (phase 4) randomized controlled trial (RCT
42    These domains encompass both the pre- and postmarketing phases of drug research.
43 e reported in 2016 leading to termination of postmarketing registry trials.
44                 This preliminary large-scale postmarketing report of the performance of ARDA after sc
45          To address this gap, an analysis of postmarketing reports of cutaneous AEs for drugs with an
46     This study was undertaken to investigate postmarketing reports of malignancy in children treated
47 ns: Our review of data from clinical trials, postmarketing reports, an ongoing registry-based ELX/TEZ
48 l insights from the HAWK and HARRIER trials, postmarketing reports, and assessments from an independe
49 large and increasing data deposited in FDA's postmarketing reports, we demonstrate that the task of p
50  understood, has been the subject of ongoing postmarketing reports.
51  the basis of premarketing studies and a few postmarketing reports.
52  single-arm trials, 45 (38%) fulfilled their postmarketing requirement to verify clinical benefit, 61
53  and Drug Administration (FDA) to review the postmarketing requirements and commitments attached to n
54 ies was extracted from the FDA's database of postmarketing requirements and commitments, ClinicalTria
55 points of pivotal efficacy trials, and their postmarketing requirements or commitments.
56                                              Postmarketing requirements were issued to evaluate long-
57 r magnitude and a better infrastructure than postmarketing research, yet issues arising in the two ph
58  could greatly enhance the infrastructure of postmarketing research.
59 The Sentinel System is a national electronic postmarketing resource established by the US Food and Dr
60                      Specific compliance and postmarketing safety issues (especially liver enzyme mon
61 meetings included voting questions regarding postmarketing safety or trial design).
62 dlines were associated with a higher rate of postmarketing safety problems (e.g., withdrawals and bla
63 e whether the deadlines were associated with postmarketing safety problems, we focused on drugs submi
64 NT treatment reports out of thirteen million postmarketing safety reports in the FDA Adverse Event Re
65                                     Pre- and postmarketing safety reports of N. gonorrhoeae infection
66            The FDA web site was searched for postmarketing safety reviews, and the FDA was contacted
67 d regulatory authorities, including enhanced postmarketing safety surveillance and new clinical study
68 of the US Food and Drug Administration (FDA) postmarketing safety surveillance commitment and uses cl
69 cs were similar in vaccines with and without postmarketing, safety-related label modifications.
70                        Rates reported in the postmarketing setting are comparable.
71 reated MS patients diagnosed with PML in the postmarketing setting were identified, of whom 22 (10 wi
72 ontinued monitoring of adverse events in the postmarketing setting will provide additional informatio
73                                       In the postmarketing setting, all patients received fingolimod,
74                                       In the postmarketing setting, reporting rates since 2010 were e
75                                       In the postmarketing setting, the exposure-adjusted reporting r
76 ting of adverse events in the trials and the postmarketing setting.
77                        Rates reported in the postmarketing settings were comparable (7 per 1000 patie
78                            We used data from postmarketing sources, clinical studies, and an independ
79 tients from natalizumab clinical studies and postmarketing sources.
80 of development cost from nonclinical through postmarketing stages were estimated: mean out-of-pocket
81 (mean [SD] PPR, 0.91; 95% CI, 0.90-0.91) and postmarketing studies (mean PPR, 1.00; 95% CI, 1.00-1.01
82 e groups continued to be underrepresented in postmarketing studies (older adults: mean PPR, 0.75; 95%
83   PPRs were constructed for premarketing and postmarketing studies and by cancer type.
84                  These findings suggest that postmarketing studies are not associated with improvemen
85                                              Postmarketing studies are underway to address some of th
86        These findings suggest that requiring postmarketing studies for breakthrough therapy-designate
87 this cross-sectional study, premarketing and postmarketing studies for novel cancer therapeutics appr
88 monstrated the need for well-designed, valid postmarketing studies of medical devices.
89  and Black patients were underrepresented in postmarketing studies of novel cancer therapeutics to a
90                                              Postmarketing studies suggest that the favorable results
91 end points, of which 4 (7%) had FDA-required postmarketing studies to confirm efficacy and 39 (64%) w
92 s as primary end points and had FDA-required postmarketing studies to confirm efficacy.
93 ccelerated approval) and lacked FDA-required postmarketing studies to verify clinical benefit.
94                                              Postmarketing studies, compared with premarketing studie
95             To assist researchers to conduct postmarketing studies, we developed a generic protocol f
96 llion for pain and anesthesia), inclusive of postmarketing studies.
97 mple included 77 premarketing studies and 56 postmarketing studies.
98 endpoints to be reported in the confirmatory postmarketing studies.
99 acterial infections and the data provided by postmarketing studies.
100 lizumab, along with the lessons learned from postmarketing studies.
101 pioid-related harms among pain patients, but postmarketing study results have been mixed.
102    The most common source of safety data was postmarketing surveillance (n = 28 of 58 [48%]).
103 ministration mandated that companies conduct postmarketing surveillance (PMS) studies of approved ste
104                                    Proactive postmarketing surveillance and further studies are pivot
105 lestra (sucrose polyester) called for active postmarketing surveillance because preapproval studies s
106               The ASRS TSC encourages active postmarketing surveillance by all physicians.
107                                              Postmarketing surveillance data would be useful in asses
108 r examining the available literature and the postmarketing surveillance data, proposed a clinically b
109                              On the basis of postmarketing surveillance data, the Food and Drug Admin
110  in prescribing this drug pending additional postmarketing surveillance data.
111                       Examination of the FDA postmarketing surveillance databases revealed a low repo
112                               Using 2 global postmarketing surveillance databases, Goldman and collea
113      Longer-term clinical trials and careful postmarketing surveillance during the next several decad
114 e US Food and Drug Association (FDA), little postmarketing surveillance exists to assess real-world r
115                                      Careful postmarketing surveillance for adverse effects, especial
116 f monitoring both pharmaceutical quality and postmarketing surveillance for adverse events.
117  these issues, data from clinical trials and postmarketing surveillance have been evaluated extensive
118  recent studies have examined how frequently postmarketing surveillance identifies important ADRs.
119                                              Postmarketing surveillance indicates that the diversion
120 tinue through clinical trials, and extend to postmarketing surveillance of ADRs in real-world populat
121       However, longer-term trial results and postmarketing surveillance of major adverse events will
122 ovigilance databases are essential tools for postmarketing surveillance of medical products.
123 ition, observational studies can be used for postmarketing surveillance of new cancer treatments, par
124 ing and documenting adverse effects; and (8) postmarketing surveillance of therapy outcomes.
125                                   Additional postmarketing surveillance of these and other serious ad
126  (VAERS) is the passive reporting system for postmarketing surveillance of vaccine safety in the Unit
127 fety issues were identified through existing postmarketing surveillance programs and were of limited
128                                              Postmarketing surveillance revealed a potential serious
129                                Strengthening postmarketing surveillance strategies and pivotal trials
130 and the importance of internationally robust postmarketing surveillance strategies as crucial compone
131 n the near future, with a call for effective postmarketing surveillance studies for all of the new en
132 le, coming from either controlled trials and postmarketing surveillance studies.
133                                  This active postmarketing surveillance study of a food additive sugg
134                                         This postmarketing surveillance study was conducted to fulfil
135 that the agency's drug review procedures and postmarketing surveillance system after a drug has been
136  Administration (FDA) is building a national postmarketing surveillance system for medical devices, m
137  limited premarketing data are balanced with postmarketing surveillance to capture rare adverse event
138  This study demonstrates the power of active postmarketing surveillance to identify or exclude events
139  authorisation procedures mandated increased postmarketing surveillance to monitor vaccine safety.
140 es as applied to preclinical drug safety and postmarketing surveillance with a specific focus on mach
141 entiary regulatory standards, development of postmarketing surveillance, a focus on clinically meanin
142  data submitted to Merck from routine global postmarketing surveillance, combined with information fr
143           However, few data are available on postmarketing surveillance.
144  and reinforce the critical need for ongoing postmarketing surveillance.
145 s for transcatheter aortic valve replacement postmarketing surveillance.
146 obustness of the vaccine approval system and postmarketing surveillance.
147 se complications will likely require careful postmarketing surveillance.
148 reported to Merck, the manufacturer, through postmarketing surveillance.
149 arly detection has largely shifted to the US postmarketing systems.
150 g approach for robust confounding control in postmarketing TND studies was also introduced.
151                  Results of premarketing and postmarketing trials have raised doubts about the cardio
152 sociated with low rates of hypoglycemia, and postmarketing trials of GLP-1RA and SGLT2i demonstrated
153                                       Recent postmarketing trials produced conflicting results about
154  program must verify the clinical benefit in postmarketing trials.
155                                        Thus, postmarketing vaccine safety assessments are necessary.
156 nt concerning HPV vaccine safety aligns with postmarketing vaccine safety surveillance data.

 
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