Specification of drug substances and products : development and validation of analytical methods.
সংরক্ষণ করুন:
| অন্যান্য লেখক: | , |
|---|---|
| বিন্যাস: | বৈদ্যুতিক বৈদ্যুতিন গ্রন্থ |
| ভাষা: | ইংরেজি |
| প্রকাশিত: |
Amsterdam :
Elsevier,
2024.
|
| সংস্করন: | Third edition / |
| বিষয়গুলি: | |
| অনলাইন ব্যবহার করুন: | ScienceDirect |
| ট্যাগগুলো: |
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| 245 | 0 | 0 | |a Specification of drug substances and products : |b development and validation of analytical methods. |
| 250 | |a Third edition / |b edited by Christopher M. Riley, K. Lien Nguyen. | ||
| 264 | 1 | |a Amsterdam : |b Elsevier, |c 2024. | |
| 300 | |a 1 online resource |b illustrations (black and white, and colour) | ||
| 336 | |a text |b txt |2 rdacontent | ||
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| 338 | |a online resource |b cr |2 rdacarrier | ||
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| 505 | 0 | |a 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 | |
| 505 | 8 | |a 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 | |
| 505 | 8 | |a 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 | |
| 505 | 8 | |a 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 | |
| 505 | 8 | |a 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 | |
| 650 | 0 | |a Drugs |x Standards. | |
| 650 | 0 | |a Drug development. | |
| 650 | 6 | |a Médicaments |x Normes. |0 (CaQQLa)201-0014648 | |
| 650 | 6 | |a Médicaments |x Développement. |0 (CaQQLa)201-0306620 | |
| 650 | 7 | |a Drug development |2 fast |0 (OCoLC)fst00898670 | |
| 650 | 7 | |a Drugs |x Standards |2 fast |0 (OCoLC)fst00898923 | |
| 700 | 1 | |a Riley, Christopher M., |e editor. | |
| 700 | 1 | |a Nguyen, K. Lien, |e editor. | |
| 776 | 0 | 8 | |i Print version: |z 0443134669 |z 9780443134661 |w (OCoLC)1405364479 |
| 776 | 0 | 8 | |i Print version: |a Riley, Christopher M. |t Specification of Drug Substances and Products |d San Diego : Elsevier,c2024 |z 9780443134661 |
| 856 | 4 | 0 | |3 ScienceDirect |u https://www.sciencedirect.com/science/book/9780443134661 |