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Quantitative Methods for Traditional Chinese Medicine Development /
Annotation
| Main Author: | |
|---|---|
| Format: | Electronic eBook |
| Language: | Inglés |
| Published: |
Chapman and Hall/CRC,
2015.
|
| Edition: | 1st. |
| Series: | Chapman and Hall/CRC Biostatistics Ser.
|
| Online Access: | Texto completo (Requiere registro previo con correo institucional) |
Table of Contents:
- Introduction ; Introduction; What Is Traditional Chinese Medicine?; Fundamental Differences; Basic Considerations for TCM Clinical Trials; Practical Issues of TCM Development; Globalization of TCM; Aim and Scope of the Book Global Pharmaceutical Development ; Introduction; Pharmaceutical Development Process; Regulatory Requirements; Practical Issues in Drug Development; Modernization of TCM Development Regulations on Traditional Chinese Medicine ; Introduction; Regulations on TCM in China; Regulations on Herbal Products in Europe; Regulations on Herbal Products as Dietary Supplements in the United States; Regulations on Herbal Products as Drug Products in the United States Reference Standards and Product Specifications ; Introduction; Reference Standards; Product Specifications; Product Characterization; Practical Issues QOL-Like.
- Quantitative Instrument for Evaluation of TCM ; Introduction; QOL Assessment; Performance Characteristics; Responsiveness and Sensitivity; Utility Analysis and Calibration; QOL-Like Instrument for Evaluation of TCM; Parallel Assessments Factor Analysis and Principal Component Analysis ; Introduction; Factor Analysis; Principal Component Analysis; Application of QOL in Hypertensive Patients Statistical Validation of Chinese Diagnostic Procedures ; Introduction; Chinese Diagnostic Procedure; Proposed Study Design; Calibration of Chinese Diagnostic Procedure; Validation of Chinese Diagnostic Procedure; A Numerical Example Statistical Test for Consistency ; Introduction; Consistency Index; Statistical Quality Control for Consistency; Tolerance Region Approach Statistical Process for Quality Control/Assurance ; Introduction; Statistical Model; Assessing Consistency.
- For QC/QA; An Example; Discussion; Appendix: Proof of Theorem Bioavailability and Bioequivalence ; Introduction; What Is Bioavailability/Bioequivalence?; Bioequivalence Assessment for Generic Approval; Drug Interchangeability; Controversial Issues; Frequently Asked Questions; Other Applications Population Pharmacokinetics ; Introduction; Regulatory Requirements; Population PK Modeling; Design of Population PK; An Example; Discussion Experience of Generic Drug Products with Multiple Components ; Introduction; In Vivo Single Fasting Bioequivalence Study; In Vivo Drug Release Testing; Issues on FDA Conjugated Estrogen Bioequivalence Guidance Stability Analysis for Drug Products with Multiple Components ; Introduction; Regulatory Requirements; Statistical Model and Methods; Stability Designs; Stability Analysis for Drug Products with Multiple Active.
- Components; Stability Analysis with Discrete Responses Case Studies ; Introduction; Nonclinical Quality by Design; Successful TCM Clinical Cases; Case Studies of Chinese Herbal Medicines Current Issues and Recent Developments ; Introduction; Critical Issues in TCM Development; Frequently Asked Questions from a Regulatory Perspective; Recent Developments References Index.