Matches in SemOpenAlex for { <https://semopenalex.org/work/W2325698766> ?p ?o ?g. }
Showing items 1 to 73 of
73
with 100 items per page.
- W2325698766 endingPage "351" @default.
- W2325698766 startingPage "345" @default.
- W2325698766 abstract "With the increasing use of overseas clinical data in clinical data packages for new drug application (NDA) in Japan, the relative amount of Japanese clinical data submitted for NDA has been decreasing. Clinical data on Japanese subjects is important for physicians to decide the course of treatment in clinical practice, and the importance of post-marketing surveillance (PMS) as a means of obtaining clinical data from Japanese subjects promptly after the launch is increasing. With the purpose to investigate measures to better utilize PMS, we examined the status of recent PMS in Japan based on review reports of new drugs as well as protocols and relevant documents of PMS conducted at Kitasato Institute Hospital.Fifty-four of 155 new drugs had conditions for approval, which required sponsors to conduct all-case surveys for a certain period of time after launching. Along with orphan drugs, some drugs used in large patient populations were required to conduct all-case surveys. As for drugs without conditions for approval, many of their protocols stipulated collection of data of over 3000 Japanese patients. Also, some protocols required collection of additional data not necessarily essential for safety evaluation of the drugs. In order to obtain Japanese clinical data in a more precise and timely manner during PMS in Japan, we encourage sponsors and regulatory authorities to consider various specific survey designs based on the characteristics of the drug and to design less burdensome report forms for proper safety evaluation. (Jpn J Clin Pharmacol Ther 2012 ;43(5) :345-351)" @default.
- W2325698766 created "2016-06-24" @default.
- W2325698766 creator A5035297003 @default.
- W2325698766 creator A5038701304 @default.
- W2325698766 creator A5062032148 @default.
- W2325698766 creator A5074126877 @default.
- W2325698766 date "2012-01-01" @default.
- W2325698766 modified "2023-09-25" @default.
- W2325698766 title "The Current Status of Post-Marketing Surveillance in Japan and Future Challenges" @default.
- W2325698766 doi "https://doi.org/10.3999/jscpt.43.345" @default.
- W2325698766 hasPublicationYear "2012" @default.
- W2325698766 type Work @default.
- W2325698766 sameAs 2325698766 @default.
- W2325698766 citedByCount "3" @default.
- W2325698766 countsByYear W23256987662014 @default.
- W2325698766 countsByYear W23256987662015 @default.
- W2325698766 countsByYear W23256987662016 @default.
- W2325698766 crossrefType "journal-article" @default.
- W2325698766 hasAuthorship W2325698766A5035297003 @default.
- W2325698766 hasAuthorship W2325698766A5038701304 @default.
- W2325698766 hasAuthorship W2325698766A5062032148 @default.
- W2325698766 hasAuthorship W2325698766A5074126877 @default.
- W2325698766 hasConcept C105795698 @default.
- W2325698766 hasConcept C126322002 @default.
- W2325698766 hasConcept C133462117 @default.
- W2325698766 hasConcept C144133560 @default.
- W2325698766 hasConcept C162853370 @default.
- W2325698766 hasConcept C197636746 @default.
- W2325698766 hasConcept C197934379 @default.
- W2325698766 hasConcept C33923547 @default.
- W2325698766 hasConcept C512399662 @default.
- W2325698766 hasConcept C535046627 @default.
- W2325698766 hasConcept C60644358 @default.
- W2325698766 hasConcept C71924100 @default.
- W2325698766 hasConcept C75480439 @default.
- W2325698766 hasConcept C86803240 @default.
- W2325698766 hasConcept C98274493 @default.
- W2325698766 hasConceptScore W2325698766C105795698 @default.
- W2325698766 hasConceptScore W2325698766C126322002 @default.
- W2325698766 hasConceptScore W2325698766C133462117 @default.
- W2325698766 hasConceptScore W2325698766C144133560 @default.
- W2325698766 hasConceptScore W2325698766C162853370 @default.
- W2325698766 hasConceptScore W2325698766C197636746 @default.
- W2325698766 hasConceptScore W2325698766C197934379 @default.
- W2325698766 hasConceptScore W2325698766C33923547 @default.
- W2325698766 hasConceptScore W2325698766C512399662 @default.
- W2325698766 hasConceptScore W2325698766C535046627 @default.
- W2325698766 hasConceptScore W2325698766C60644358 @default.
- W2325698766 hasConceptScore W2325698766C71924100 @default.
- W2325698766 hasConceptScore W2325698766C75480439 @default.
- W2325698766 hasConceptScore W2325698766C86803240 @default.
- W2325698766 hasConceptScore W2325698766C98274493 @default.
- W2325698766 hasIssue "5" @default.
- W2325698766 hasLocation W23256987661 @default.
- W2325698766 hasOpenAccess W2325698766 @default.
- W2325698766 hasPrimaryLocation W23256987661 @default.
- W2325698766 hasRelatedWork W1966768512 @default.
- W2325698766 hasRelatedWork W2541291474 @default.
- W2325698766 hasRelatedWork W2590183723 @default.
- W2325698766 hasRelatedWork W2746282385 @default.
- W2325698766 hasRelatedWork W2920807914 @default.
- W2325698766 hasRelatedWork W3092099373 @default.
- W2325698766 hasRelatedWork W3203879531 @default.
- W2325698766 hasRelatedWork W4205249249 @default.
- W2325698766 hasRelatedWork W4285031144 @default.
- W2325698766 hasRelatedWork W4288723778 @default.
- W2325698766 hasVolume "43" @default.
- W2325698766 isParatext "false" @default.
- W2325698766 isRetracted "false" @default.
- W2325698766 magId "2325698766" @default.
- W2325698766 workType "article" @default.