Bioavailability of generic ritonavir and lopinavir/ritonavir tablet products in a dog model

✍ Scribed by Kevin W. Garren; Sibtain Rahim; Kennan Marsh; John B. Morris

• Publisher: John Wiley and Sons
• Year: 2010
• Tongue: English
• Weight: 52 KB
• Volume: 99
• Category: Article
• ISSN: 0022-3549
• DOI: 10.1002/jps.22048

✦ Synopsis

We would like to respond to the two Letters to the Editor that have been submitted in response to our manuscript reporting on the relative bioavailability of generic ritonavir and lopinavir/ritonavir tablet products in dogs.

Both Letters criticize the dog model used in our studies, suggesting that the dog data should be interpreted with caution, and that dog bioequivalence testing should not replace appropriately designed human bioequivalence studies. As stated in our manuscript, this particular dog model was developed in our laboratories specifically for ritonavir and lopinavir/ritonavir formulations, and has been used to guide development of Abbott's Norvir 1 and Kaletra 1 products. Relative bioavailability studies in this dog model are not intended to replace appropriately designed human bioequivalence studies, but may provide some guidance in the absence of publicly available human data, which was the case at the time our testing of the generic ritonavir and lopinavir/ ritonavir products was conducted.

Human bioequivalence data on generic lopinavir/ ritonavir and ritonavir tablet products is important information for the HIV-treating community. Matrix Laboratories Limited