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Handbook of bioequivalence testing / Sarfaraz K. Niazi.
- Format:
- Book
- Author/Creator:
- Niazi, Sarfaraz, 1949- author.
- Series:
- Drugs and the pharmaceutical sciences ; 0360-2583 v. 213.
- Drugs and the pharmaceutical sciences ; volume 213
- Language:
- English
- Subjects (All):
- Drugs--Therapeutic equivalency.
- United States.
- Drugs--Therapeutic equivalency--Handbooks, manuals, etc.
- Drugs.
- Therapeutic Equivalency.
- Drug Approval.
- Models, Statistical.
- Medical Subjects:
- United States.
- Therapeutic Equivalency.
- Drug Approval.
- Models, Statistical.
- Genre:
- Handbooks and manuals.
- Physical Description:
- 1 online resource (li, 955 pages) : illustrations.
- Edition:
- Second edition.
- Place of Publication:
- Boca Raton, FL : CRC Press/Taylor & Francis Group, [2015]
- System Details:
- text file
- Contents:
- Chapter 1. Historical perspective on generic pharmaceuticals
- chapter 2. Physicochemical basis of bioequivalence testing
- chapter 3. Drug delivery factors
- chapter 4. Pharmacokinetic/pharmacodynamic (PK/PD) modeling
- chapter 5. Bioequivalence testing rationale and principles
- chapter 6. Bioequivalence waivers
- chapter 7. Statistical evaluation of bioequivalence data
- chapter 8. Regulatory inspection process
- chapter 9. Fed bioequivalence studies
- chapter 10. Topical drugs
- chapter 11. Bioequivalence of nasal products
- chapter 12. Bioequivalence of complimentary and alternate medicines
- chapter 13. Bioequivalence of biosimilar products
- chapter 14. Bioequivalence testing : the U.S. perspective
- chapter 15. Bioequivalence testing : European perspective
- chapter 16. Bioequivalence testing : the ROW perspective
- chapter 17. Bioequivalence testing protocols
- chapter 18. Bioequivalence documentation
- chapter 19. Good laboratory practices
- chapter 20. Bioanalytical method validation
- chapter 21. Good clinical practice
- chapter 22. Computer and software validation
- chapter 23. Outsourcing and monitoring of bioequivalence studies
- chapter 24. Epilog : future of bioequivalence testing.
- Notes:
- Includes bibliographical references and index.
- Electronic reproduction. London Available via World Wide Web.
- Description based on print version record.
- Local Notes:
- Acquired for the Penn Libraries with assistance from the Lippincott Library Book Endowment Fund.
- ISBN:
- 9781482226386
- 1482226383
- Publisher Number:
- 99978144163
- Access Restriction:
- Restricted for use by site license.
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