Matches in SemOpenAlex for { <https://semopenalex.org/work/W20124173> ?p ?o ?g. }
Showing items 1 to 54 of
54
with 100 items per page.
- W20124173 endingPage "308" @default.
- W20124173 startingPage "271" @default.
- W20124173 abstract "Publisher Summary Clinical Trials in Latin America are explained the chapter below. The Latin American region is one of the top emerging markets, together with South East Asia and Eastern Europe. No Latin American country is a signatory of ICH-GCP guidelines. In Latin America, ICFs for clinical trials undergo rigorous inspection, which can delay trial approval. This critical document requires extensive review on a country-by-country basis. It is common for the ICF to trigger the greatest number of questions from ethics committees and regulatory authorities. The time required to initiate a clinical trial varies among Latin American countries. An import license is always required in Latin American countries. In the 1990s, a first phase of safety systems development began in Latin America, as a great number of countries joined the network of participating countries of the World Health Organization (WHO) Program for International Drug Monitoring coordinated by the Uppsala Monitoring center. Suspected unexpected serious adverse reaction SUSAR reporting to regulatory authorities must also comply with local requirements in terms of format, timelines, language, and delivery means. The US FDA is involved in review of clinical trials conducted elsewhere by virtue of the need to ensure the integrity of data that the sponsor submits to the agency to support marketing approval in the USA. Experience has proven that the quality of data collected in Latin America is similar to that of North American data, demonstrating the clinical research potential of the region." @default.
- W20124173 created "2016-06-24" @default.
- W20124173 creator A5015207029 @default.
- W20124173 creator A5016603838 @default.
- W20124173 creator A5029441861 @default.
- W20124173 creator A5038496903 @default.
- W20124173 creator A5052216946 @default.
- W20124173 creator A5081266574 @default.
- W20124173 date "2011-01-01" @default.
- W20124173 modified "2023-09-24" @default.
- W20124173 title "Clinical Trials in Latin America" @default.
- W20124173 cites W2047150424 @default.
- W20124173 cites W4255917031 @default.
- W20124173 doi "https://doi.org/10.1016/b978-0-12-381537-8.10014-7" @default.
- W20124173 hasPublicationYear "2011" @default.
- W20124173 type Work @default.
- W20124173 sameAs 20124173 @default.
- W20124173 citedByCount "7" @default.
- W20124173 countsByYear W201241732013 @default.
- W20124173 countsByYear W201241732014 @default.
- W20124173 countsByYear W201241732019 @default.
- W20124173 countsByYear W201241732021 @default.
- W20124173 crossrefType "book-chapter" @default.
- W20124173 hasAuthorship W20124173A5015207029 @default.
- W20124173 hasAuthorship W20124173A5016603838 @default.
- W20124173 hasAuthorship W20124173A5029441861 @default.
- W20124173 hasAuthorship W20124173A5038496903 @default.
- W20124173 hasAuthorship W20124173A5052216946 @default.
- W20124173 hasAuthorship W20124173A5081266574 @default.
- W20124173 hasConcept C158886217 @default.
- W20124173 hasConcept C17744445 @default.
- W20124173 hasConcept C199539241 @default.
- W20124173 hasConceptScore W20124173C158886217 @default.
- W20124173 hasConceptScore W20124173C17744445 @default.
- W20124173 hasConceptScore W20124173C199539241 @default.
- W20124173 hasLocation W201241731 @default.
- W20124173 hasOpenAccess W20124173 @default.
- W20124173 hasPrimaryLocation W201241731 @default.
- W20124173 hasRelatedWork W120808420 @default.
- W20124173 hasRelatedWork W2040887421 @default.
- W20124173 hasRelatedWork W2154057315 @default.
- W20124173 hasRelatedWork W2217694111 @default.
- W20124173 hasRelatedWork W2254250433 @default.
- W20124173 hasRelatedWork W2912771078 @default.
- W20124173 hasRelatedWork W3022347140 @default.
- W20124173 hasRelatedWork W4312372980 @default.
- W20124173 hasRelatedWork W633427133 @default.
- W20124173 hasRelatedWork W94689695 @default.
- W20124173 isParatext "false" @default.
- W20124173 isRetracted "false" @default.
- W20124173 magId "20124173" @default.
- W20124173 workType "book-chapter" @default.