الدليل التنظيمي لتسمية المنتجات الدوائية البشرية
(الإصدار-4)
ويشمل العناوين التالي
1 Introduction 3
1.1 Objective 3
1.2 Background 3
2 Scope 3
3 abbreviations
4 Definitions
5 Safety Concerns
6 Assessment the Proposed Trade Name for Attributes that could potentially contribute in 5
Medication Errors.
6.1 Comprehensively recognizable Spelling and Pronunciation Similarities of Proprietary names.
6.2 Combinations of Active Ingredients
6.3 Inert or Inactive Ingredients
6.4 International Non-Proprietary Names (INN) and United States Adopted Name Stems
6.5 Family Branding (Family Trade Names)
6.6 Reusing Cancelled Trade Names
6.7 Using Unpronounceable Letters and Numeric Characters in Trade Names
6.8 Names That Include Product-Specific Attributes
6.9 Medical Abbreviations
6.10 Modifiers as Components of a Trade Name
7 Further best practices for review, including for misbranding and other legal concerns
8 Recommended methods for assessing the risk of medication error caused by a proposed
trade name's similarity to other names.
8.1 Computational Method to Identify Names with Potential Orthographic, Spelling, and Phonetic
Similarities
8.2 Assessing the Safety of Names That May Have Phonetic, Orthographic, or Spelling Similarities
9 References
10- Document History
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