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

Latest Issue
PharmTech

Latest Issue
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).


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
30%
Attracting a skilled workforce
27%
Obtaining/maintaining adequate financing
14%
Regulatory compliance
30%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Obama Administration Halts Attack on Medicare Drug Plans
Source: Pharmaceutical Technology,
Click here