Extractables and Leachables Characterization of Drug Products Packaging Manufacturing and Delivery Systems and Medical Devices 1st edition by Dennis Jenke 1119605105 9781119605102

Extractables and Leachables: Characterization of Drug Products, Packaging, Manufacturing and Delivery Systems & Medical Devices 1st edition by Dennis Jenke 1119605105 9781119605102 – Ebook PDF Instant Download/DeliveryISBN: 

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Product details:

ISBN-10 :  1119605105 

ISBN-13 :  9781119605102

Author :  Dennis Jenke 

Extractables and Leachables: Characterization of Drug Products, Packaging, Manufacturing and Delivery Systems, and Medical Devices
Characterization of Drug Products, Packaging, Manufacturing and Delivery Systems, and Medical Devices
Pharmaceutical scientists, engineers, and toxicologists in areas like product development, regulatory affairs, analytical science, quality control, and manufacturing

Managers and directors from formulation development, packaging department, packaging QA, regulatory affairs, analytical development

 

Extractables and Leachables: Characterization of Drug Products, Packaging, Manufacturing and Delivery Systems & Medical Devices 1st Table of contents:

1 Introduction and Essential Concepts
1.1 General Discussion
1.2 Regulations, Guidelines, Standards, and Recommendations for Chemical Compatibility Assessments
1.3 Why Chemical Assessment?
1.4 An Overview of the Chemical Compatibility Assessment Process
1.5 Looking Ahead
References
2 General Principles of Chemical Compatibility Assessment: Extraction and Leaching
2.1 Key Definitions and Concepts, Extractables, and Leachables
2.2 Extraction Studies
2.3 Leaching Studies
2.4 Variation in Extraction and Leaching Studies
References
3 General Principles of Chemical Assessment: Analytical Testing for Extractables and Leachables; Organic Compounds
3.1 Key Definitions and Concepts
3.2 Organic Substance Analysis, Screening
3.3 Organic Substance Analysis: Targeting
3.4 Organic Substance Analysis: Targeted Screening
3.5 Extractables/Leachables Correlations
3.6 Intra‐laboratory Variation in Extractables/Leachables Profiles
References
4 General Principles of Chemical Assessment: Analytical Testing for Extractables and Leachables; Elements, Anions, and General Testing
4.1 Elemental Analysis
4.2 Ionic Extractables
4.3 Scouting via General Chemical Analysis
References
5 Extractables, Leachables, and the Product Lifecycle Through Product Approval and Launch
5.1 Introduction
5.2 Situation
5.3 Definitions
5.4 The Chemical Compatibility Assessment Process
5.5 Elements of the Chemical Assessment Strategy
5.6 Advanced Topics in Chemical Compatibility Assessment
References
6 Extractables, Leachables, and the Product Development Lifecycle: Change Control
6.1 Stage 4: Lifecycle Management and Change Control via a Comparability Protocol
6.2 Stage 4: Life‐Cycle Management and Change Control via a Risk‐Based Approach
References
7 Applications – Pharmaceutical Drug Products – Packaging
7.1 Classification of Packaging Systems and Components
7.2 Pharmacopeial Monographs
7.3 Regulatory Guidance
7.4 Best Practice Recommendations
7.5 Risk Classification of Packaging Systems
7.6 Assessments of Drug Products, Packaging Systems, and Materials of Construction Based on Risk Classification
7.7 Case Studies
References
8 Applications – Pharmaceutical Drug Products – Manufacturing Components and Systems
8.1 Introduction
8.2 Industry Perspectives
8.3 Compendial Guidance, USP and
8.4 Flexibility in the Implementation of USP
8.5 Risk Classification of Manufacturing Components
8.6 Case Studies
References
9 Applications – Medical Devices
9.1 Introduction
9.2 Regulatory Landscape: ISO 10993; Generating an Extract
9.3 Linking Extraction Conditions to Medical Device Categories
9.4 Chemical Testing of Extracts
9.5 The Chemical Characterization Process for Medical Devices per ISO 10993:18(2020)
9.6 FDA Recognition of Part 18
9.7 Medical Device Packaging
9.8 Case Studies
References
10 General Principles for Risk Assessment of Extractables and Leachables
10.1 Toxicological Safety Risk Assessment of Extractables and Leachables
10.2 The Special Case of Biologics
10.3 Biological Safety Risk Assessment
10.4 The Use of Auxiliary Information in Safety Risk Assessment
10.5 Are Organic Extractables and Leachables Inherently Unsafe?
10.6 Assessing Risks Other Than Patient Safety
References
11 Focus on Emerging Concepts
11.1 A Dose of Reality
11.2 Designing and Implementing Better Extractions
11.3 Achieving Better Analytical Outcomes
11.4 Information Sharing for the Common Good
11.5 Replacing the Lab with a Computer (Mathematical Modeling)
11.6 Consider the Impact of a Result Before Attempting to Improve It
11.7 Recent Publications
11.8 USP Biological Reactivity Testing
11.9 I’ll Pass on That
11.10 The End of E&L?

 

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