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Specification of drug substances and products : development and validation of analytical methods.

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Bibliografiske detaljer
Andre forfattere: Riley, Christopher M. (Editor), Nguyen, K. Lien (Editor)
Format: Electronisk eBog
Sprog:engelsk
Udgivet: Amsterdam : Elsevier, 2024.
Udgivelse:Third edition /
Fag:
Drugs > Standards.
Drug development.
Médicaments > Normes.
Médicaments > Développement.
Drug development
Drugs > Standards
Online adgang:ScienceDirect
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Indholdsfortegnelse:
  • Front Cover
  • SPECIFICATION OF DRUG SUBSTANCES AND PRODUCTS
  • SPECIFICATION OF DRUG SUBSTANCES AND PRODUCTS: DEVELOPMENT AND VALIDATION OF ANALYTICAL METHODS
  • Copyright
  • Contents
  • Contributors
  • About the editors
  • I
  • Introduction
  • 1
  • Introduction
  • 1.1 Historical perspective
  • 1.1.1 International guidelines
  • 1.1.2 Quality guidelines
  • 1.1.3 Multidisciplinary guidelines
  • 1.2 Specifications: General principles
  • 1.2.1 Universal tests
  • 1.2.2 Product specific (performance) tests
  • 1.2.3 Biological products
  • 1.2.4 Drug-device combination products
  • 1.2.5 Stability
  • 1.2.6 Critical quality attributes and patient centric specifications
  • 1.2.7 Nonclinical and clinical trials materials
  • 1.3 Analytical methods
  • 1.4 Validation of analytical methods and the reporting of analytical results
  • 1.4.1 Phase appropriate validation
  • 1.4.2 Verification of pharmacopoeial methods
  • 1.5 Conclusions
  • References
  • II
  • Regulatory considerations and statistical approaches
  • 2
  • Principles for setting specifications and shelf lives
  • 2.1 Introduction
  • 2.2 Regulatory requirements and guidelines
  • 2.2.1 International Council on Harmonization (ICH) of the Technical Requirements for Pharmaceuticals for Human Use
  • 2.2.2 Good Manufacturing Practices
  • 2.2.3 Pharmacopeia
  • 2.3 Specification setting process
  • 2.3.1 Identification of critical quality attributes
  • 2.3.2 Process establishment, risk management, and control strategy
  • 2.4 Elements to include in specifications
  • 2.4.1 Product description
  • 2.4.2 Identity
  • 2.4.3 Physical characteristics
  • 2.4.4 Composition
  • 2.4.5 Dosage form
  • 2.4.6 Packaging
  • 2.4.7 Identification test
  • 2.4.8 Purity/potency test
  • 2.4.9 Impurities
  • 2.4.10 Microbiological methods
  • 2.4.11 Compendial tests and limits
  • 2.4.12 Acceptance criteria
  • 2.5 Scientific considerations in setting acceptance criteria
  • 2.5.1 Specifications in early development
  • 2.5.2 Clinical relevance
  • 2.6 Statistical considerations for setting acceptable limits
  • 2.6.1 Data sources
  • 2.6.2 Frame of reference
  • 2.6.3 Sources of variation
  • 2.6.4 Multivariate specifications
  • 2.6.5 Types of statistical intervals
  • 2.6.6 Release and stability acceptance criteria
  • 2.7 Evaluation of stability data and determination of shelf life
  • 2.7.1 Evaluation of stability data: deciding on statistical analysis
  • 2.7.2 Principles of statistical models for stability data
  • 2.7.3 Statistical approaches
  • 2.7.3.1 Fixed lot model as described in ICH Q1E
  • 2.7.3.2 Random lots model
  • 2.7.3.3 Other statistical approaches
  • 2.7.4 Evaluating model output
  • 2.7.4.1 Verifying model assumptions
  • 2.7.4.2 Determining shelf-life based on confidence bounds
  • 2.7.4.3 Example using the fixed lot model
  • 2.7.4.4 Example using the random lot model
  • 2.7.5 Practical considerations
  • 2.7.5.1 Precision in results

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