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PubPharm (21)
1
Estimation of a Suitable Number of Patients for Selective Safety Data Collection (ICH E19 Draft Guideline) : When is the Safety Profile of a Drug Well Characterized?
enthalten in:
Therapeutic innovation & regulatory science
| 2022
von
Saeki, H.
|
Komeda, T.
|
Tanaka, R.
| +2
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2
How Many Clinical Trials Exist that Have Adopted Selective Safety Data Collection? NEJM Literature Search Results : The Possibility of Harmonizing the ICH E19 Guideline
enthalten in:
Therapeutic innovation & regulatory science
| 2022
von
Yamatani, Y.
|
Saeki, H.
|
Tanaka, R.
| +3
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3
Comparison of the incidence of bleeding between baloxavir marboxil and other anti-influenza drugs among outpatients with influenza virus infection : A retrospective cohort study using an employment-based health insurance claims database in Japan
enthalten in:
Pharmacoepidemiology and drug safety
| 2022
von
Hara, A.
|
Hara, K.
|
Komeda, T.
| +6
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4
How Many Clinical Trials Exist that Have Adopted Selective Safety Data Collection? NEJM Literature Search Results: The Possibility of Harmonizing the ICH E19 Guideline
enthalten in:
Therapeutic innovation & regulatory science
| 2022
von
Yamatani, Y.
|
Saeki, H.
|
Tanaka, R.
| +3
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5
How Many Clinical Trials Exist that Have Adopted Selective Safety Data Collection? NEJM Literature Search Results: The Possibility of Harmonizing the ICH E19 Guideline
enthalten in:
Therapeutic innovation & regulatory science
| 2022
von
Yamatani, Y.
|
Saeki, H.
|
Tanaka, R.
| +3
Wird geladen...
6
How Many Clinical Trials Exist that Have Adopted Selective Safety Data Collection? NEJM Literature Search Results: The Possibility of Harmonizing the ICH E19 Guideline
enthalten in:
Therapeutic innovation & regulatory science
| 2022
von
Yamatani, Y.
|
Saeki, H.
|
Tanaka, R.
| +3
Wird geladen...
7
Estimation of a Suitable Number of Patients for Selective Safety Data Collection (ICH E19 Draft Guideline): When is the Safety Profile of a Drug Well Characterized?
enthalten in:
Therapeutic innovation & regulatory science
| 2022
von
Saeki, H.
|
Komeda, T.
|
Tanaka, R.
| +2
Wird geladen...
8
Estimation of a Suitable Number of Patients for Selective Safety Data Collection (ICH E19 Draft Guideline): When is the Safety Profile of a Drug Well Characterized?
enthalten in:
Therapeutic innovation & regulatory science
| 2022
von
Saeki, H.
|
Komeda, T.
|
Tanaka, R.
| +2
Wird geladen...
9
Estimation of a Suitable Number of Patients for Selective Safety Data Collection (ICH E19 Draft Guideline): When is the Safety Profile of a Drug Well Characterized?
enthalten in:
Therapeutic innovation & regulatory science
| 2022
von
Saeki, H.
|
Komeda, T.
|
Tanaka, R.
| +2
Wird geladen...
10
Comparison of the incidence of bleeding between baloxavir marboxil and other anti‐influenza drugs among outpatients with influenza virus infection : A retrospective cohort study using an employment‐based health insurance claims database in Japan
enthalten in:
Pharmacoepidemiology and Drug Safety
| 2022
von
Hara, A.
|
Hara, K.
|
Komeda, T.
| +6
Wird geladen...
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21
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Therapeutic innovation & regulatory science
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Journal of infection and chemotherapy : officia...
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Clinical infectious diseases : an official publ...
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Biological & pharmaceutical bulletin
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Biological and pharmaceutical bulletin
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Journal of pharmacy and pharmacology
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Pharmacoepidemiology and drug safety
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The Journal of pharmacy and pharmacology
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Thema
11
Journal Article
9
Research Support, Non-U.S. Gov't
8
Selective safety data collection
7
Antiviral Agents
5
EC 3.2.1.18
5
Neuraminidase
4
4G86Y4JT3F
4
Clinical trial
4
Dibenzothiepins
4
Half-width of two-sided 95% confidence interval
4
ICH E19 guideline
4
ICH guideline
4
Incidence rate
4
Morpholines
4
Pyridones
4
Risk difference
4
SSDC
4
Safety data
4
Simulation
4
Suitable number of patients
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Erscheinungszeitraum
14
2020-
7
2010-2019
Erscheinungsjahr(e)
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Sprache
18
Englisch
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