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The book's authors have been carefully selected as former members of the ICH Expert Working Groups charged with developing the ICH guidelines, and/or subject-matter experts in the industry, academia and in government laboratories.
The book's authors have been carefully selected as former members of the ICH Expert Working Groups charged with developing the ICH guidelines, and/or subject-matter experts in the industry, academia and in government laboratories.
2. General Principles and Regulatory Considerations: Specifications and Shelf Life Setting
3. General Principles and Regulatory Considerations: Method Development and Validation
4. Application of Quality by Design (QbD) to the Development and Validation of Analytical Methods
5. Analytical Methods in the Clinical Phase of Development
6. Method Transfer
7. Process Analytical Technology PART 2 UNIVERSAL TESTS8. Description and Identification
9. Assay and Impurities: Specifications
10. Assay and Impurities: Method Development and Life-Cycle Management
11. Assay and Impurities: Method Validation
12. Mutagenic Impurities
13. Residual Solvents
14. Inorganic Impurities (Elemental Impurities) PART 3 SPECIFIC TESTS: DRUG SUBSTANCES15. Solid State Characterization
16. Chiral Methods
17. Water Determination PART 4 SPECIFIC TESTS DRUG PRODUCT18. Drug Release: Oral Products
19. Topical Products
20. Extractables and Leachables PART 5 BIOTECHNOLOGY PRODUCTS21. Regulatory Requirements for Setting Drug Substance and Drug Product Specifications
22. Validation of Analytical Methods for Biotechnology Products PART 6 PHARMACOPEIAL METHODS23. Pharmacopeial Methods and Test (Updated) PART 7 BIOLOGICAL FLUIDS24. Biological Fluids
| Erscheinungsjahr: | 2020 |
|---|---|
| Medium: | Taschenbuch |
| Inhalt: | Kartoniert / Broschiert |
| ISBN-13: | 9780081028247 |
| ISBN-10: | 0081028245 |
| Sprache: | Englisch |
| Herstellernummer: | C2018-0-00966-4 |
| Autor: | Riley, Christopher M. |
| Redaktion: |
Riley, Christopher M.
Rosanske, Thomas W. Reid, George L. |
| Auflage: | 2. Aufl. |
| Hersteller: |
Elsevier
Elsevier Science & Technology |
| Verantwortliche Person für die EU: | Zeitfracht Medien GmbH, Ferdinand-Jühlke-Str. 7, D-99095 Erfurt, produktsicherheit@zeitfracht.de |
| Maße: | 32 x 191 x 235 mm |
| Von/Mit: | Christopher M. Riley (u. a.) |
| Erscheinungsdatum: | 24.07.2020 |
| Gewicht: | 1,54 kg |
2. General Principles and Regulatory Considerations: Specifications and Shelf Life Setting
3. General Principles and Regulatory Considerations: Method Development and Validation
4. Application of Quality by Design (QbD) to the Development and Validation of Analytical Methods
5. Analytical Methods in the Clinical Phase of Development
6. Method Transfer
7. Process Analytical Technology PART 2 UNIVERSAL TESTS8. Description and Identification
9. Assay and Impurities: Specifications
10. Assay and Impurities: Method Development and Life-Cycle Management
11. Assay and Impurities: Method Validation
12. Mutagenic Impurities
13. Residual Solvents
14. Inorganic Impurities (Elemental Impurities) PART 3 SPECIFIC TESTS: DRUG SUBSTANCES15. Solid State Characterization
16. Chiral Methods
17. Water Determination PART 4 SPECIFIC TESTS DRUG PRODUCT18. Drug Release: Oral Products
19. Topical Products
20. Extractables and Leachables PART 5 BIOTECHNOLOGY PRODUCTS21. Regulatory Requirements for Setting Drug Substance and Drug Product Specifications
22. Validation of Analytical Methods for Biotechnology Products PART 6 PHARMACOPEIAL METHODS23. Pharmacopeial Methods and Test (Updated) PART 7 BIOLOGICAL FLUIDS24. Biological Fluids
| Erscheinungsjahr: | 2020 |
|---|---|
| Medium: | Taschenbuch |
| Inhalt: | Kartoniert / Broschiert |
| ISBN-13: | 9780081028247 |
| ISBN-10: | 0081028245 |
| Sprache: | Englisch |
| Herstellernummer: | C2018-0-00966-4 |
| Autor: | Riley, Christopher M. |
| Redaktion: |
Riley, Christopher M.
Rosanske, Thomas W. Reid, George L. |
| Auflage: | 2. Aufl. |
| Hersteller: |
Elsevier
Elsevier Science & Technology |
| Verantwortliche Person für die EU: | Zeitfracht Medien GmbH, Ferdinand-Jühlke-Str. 7, D-99095 Erfurt, produktsicherheit@zeitfracht.de |
| Maße: | 32 x 191 x 235 mm |
| Von/Mit: | Christopher M. Riley (u. a.) |
| Erscheinungsdatum: | 24.07.2020 |
| Gewicht: | 1,54 kg |
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