The Value of In Vitro Dissolution in Drug Development - Pharmaceutical Technology

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PharmTech Europe

The Value of In Vitro Dissolution in Drug Development
A Position Paper from the AAPS In Vitro Release and Dissolution Focus Group


Pharmaceutical Technology
Volume 33, Issue 4, pp. 52-64

9. FDA, Guidance for Industry: SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation (Rockville, MD, 1997).

10. FDA, Guidance for Industry: Immediate-Release Solid Oral Dosage Forms. Scale-up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation (Rockville, MD, 1995).

11. S. Azarmi, W. Roa, and R. Löbenberg, "Current Perspectives in Dissolution Testing of Conventional and Novel Dosage Forms," Int. J. Pharm. 328 (1), 12–21 (2007).

12. W.E. Bowen et al., "A Biopharmaceutical Classification System Approach to Dissolution: Mechanisms and Strategies," in Biopharmaceutics Applications in Drug Development (Springer US, 2008) pp. 290-316.

13. C. Tong et al., "Commentary on AAPS Workshop: Dissolution Testing for the Twenty-first Century: Linking Critical Quality Attributes and Critical Process Parameters to Clinically Relevant Dissolution," Pharm. Res. 24 (9), 1603–1607 (2007).

14. FDA, Guidance for Industry: Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System (Rockville, MD, 2000).

15. WHO, "Proposal to Waive In Vivo Bioequivalence Requirements for the WHO Model List of Essential Medicines Immediate Release, Solid Oral Dosage Forms," working document QAS/04.109/Rev.1, 2005.

16. EMEA, "Note for Guidance on the Investigation of Bioavailability and Bioequivalence. European Agency for Evaluation of Medicinal Products, Committee for Proprietary Medicinal Products," (London, England) 2001.

17. E. Rinaki et al., "Identification of Biowaivers Among Class II Drugs: Theoretical Justification and Practical Examples," Pharm. Res. 21 (9), 1567–1572 (2004).

18. M. Yazdanian et al., "The 'High Solubility' Definition of the Current FDA Guidance on Biopharmaceutical Classification System May Be Too Strict for Acidic Drugs," Pharm. Res. 21 (2), 293–299 (2004).

19. FDA, Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products—General Considerations (Rockville, MD, 2003).


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