In Vitro/In Vivo Correlation for Modified Release Injectable Drug Delivery Systems

Injectable Dispersed Systems: Formulation, Processing, and Performance

Volumn , Issue , 2005, Pages 159-176

  Young, David ^a   Farrell, Colm ^a   Shepard, Theresa ^a  

^a ICON PLC   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 41249094856     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1201/9780849350610-9     Document Type: Chapter

References (14)

1. Food and Drug Administration Guidance for Industry. Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations, CDER 09, 1997.
2. Food and Drug Administration Guidance for Industry. SUPACMR:Modified Release Solid Oral Dosage Forms, CDER 09, 1997.
3. Food and Drug Administration Guidance for Industry. SUPACIR:immediate Release Solid Oral Dosage Forms, CDER 10, 1997.
4. Food and Drug Administration Guidance for Industry. Bioavailability and Bioequivalence Studies for Orally Administered Drug Products-General Considerations, CDER 10, 2000.
5. Burgess DJ, Hussain AS, Ingallinera TS, Chen M. Assuring quality and performance of sustained and controlled release parenterals. AAPSPharmSci 2002; 4(2):7 (http://www.aaps pharmsci.org/).
6. Burgess DJ, Crommelin DJA, Hussain AS, Chen M-L. Assuring quality and performance of sustained and controlled release parenterals: EUFEPS Workshop Report. AAPSPharmSci 2004; 6(1):11. Available at http://www.aapspharmsci.org/.
7. Young D, Devane JG, Butler J, eds. Advances in Experimental Medicine and Biology-Volume 23: In Vitro-In Vivo Correlations. New York: Plenum Press, 1997.
8. PDx-IVIVC2 Tools for In Vitro-In Vivo Correlation; PDx by GloboMax.
9. Bigora S, Farrell C, Shepard T, Young D. IVIVC Applied Workshop Manual - Principles and Hands-on Applications in Pharmaceutical Development; PDx by GloboMax.
10. Gillespie WR. Advances in Experimental Medicine and Biology-Volume 23: In Vitro-In Vivo Correlations; Chapter 5, Convolution-Based Approaches for In Vivo-In Vitro Correlation Modeling. New York: Plenum Press, 1997.
11. Devane J. Advances in Experimental Medicine and Biology-Volume 23: In Vitro-In Vivo Correlations; Chapter 23, Impact of IVIVR on Product Development. New York: Plenum Press, 1997.
12. Woo BH, Kostanski JW, Gebrekidan S, Dani B, Thanoo BC, DeLuca P. Preparation, characterization and in vivo evaluation of 120-day Ply (d, l-lactide) leuprolide microspheres. J Control Release 2001; 75:307-315.
13. Young D. Personal Communication, 2002.
14. Young D. Personal Communication, 2001.