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Standard for Exchange of Non-clinical Data
Results: 6

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1	CDER / CBER Study Data Standardization Plan Recommendations ABC Pharma Company Study Data Standardization Plan 1. General Sponsor Information Add to Reading List Source URL: www.fda.gov Language: English Statistics Pharmacology Clinical trials Standards organizations Clinical Data Interchange Standards Consortium SDTM MedDRA Bioequivalence Standard for Exchange of Non-clinical Data Clinical research Research Food and Drug Administration
2	Poster INHAND and SEND Update-revised 12April14.ppt Add to Reading List Source URL: www.toxpath.org Language: English - Date: 2014-06-13 14:00:57 Food and Drug Administration Pharmacology Clinical trials Medical informatics Clinical Data Interchange Standards Consortium SDTM Standard for Exchange of Non-clinical Data Peer review Clinical research Research Science
3	Study Data Tabulation Model v1.1 Add to Reading List Source URL: www.nthanalytics.com Language: English - Date: 2010-02-09 22:16:19 Health Food and Drug Administration Medical informatics Standards organizations SDTM Health informatics Clinical Data Interchange Standards Consortium Standard for Exchange of Non-clinical Data Exec Computing Statistics Clinical trials
4	CDISC SDTM Implementation Process Michael Todd President Add to Reading List Source URL: www.nthanalytics.com Language: English - Date: 2010-02-09 22:16:49 Medical informatics Medicine Clinical trials Food and Drug Administration Clinical Data Interchange Standards Consortium SDTM Electronic Common Technical Document Bioequivalence Standard for Exchange of Non-clinical Data Research Clinical research Clinical Data Management
5	PharmaSUG China Submission of Pharmacokinetics (PK) Data in a CDISC Compliant Format Yu Zhu, PPD LLC., Shanghai ABSTRACT The legacy Pharmacokinetic (PK) data are usually produced from different sources with different da Add to Reading List Source URL: www.pharmasug.org Language: English - Date: 2014-09-01 22:23:00 Food and Drug Administration SDTM Clinical Data Interchange Standards Consortium SAS Data set Parameter Variable Standard for Exchange of Non-clinical Data Statistics Clinical trials Computing
6	CDER_Common_Data_Standards_Issues_Doc_version1.1_Dec_2011.docx Add to Reading List Source URL: www.fda.gov Language: English Clinical trials Research SDTM Pharmacology Clinical Data Management Clinical Data Interchange Standards Consortium Standard for Exchange of Non-clinical Data Data set MedDRA Statistics Food and Drug Administration Clinical research

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