MULTIDISCIPLINARY GUIDELINES
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Last updated 5:54 PM on 1/3/26
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15 Terms
1
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MedDRA Terminology
M1
2
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Electronic Standards
M2
3
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Nonclinical Safety Studies
M3
4
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Common Technical Document
M4
5
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Data Elements and Standards for Drug Dictionaries
M5
6
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Gene Therapy
M6
7
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Mutagenic Impurities
M7
8
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Electronic Common Technical Document (eCTD)
M8
9
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Biopharmaceutics Classification System-based
Biowaivers
M9
10
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Bioanalytical Method Validation and Study Sample
Analysis
M10
11
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Clinical electronic Structured Harmonised Protocol
(CeSHarP)
M11
12
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Drug Interaction Studies
M12
13
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Bioequivalence for Immediate-Release Solid Oral Dosage Forms
M13
14
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Use of real-world data for safety assessment of
medicines
M14
15
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General Principles for Model-Informed Drug
Development
M15
Note 
Flashcards (23)