The Experts below are selected from a list of 1101 Experts worldwide ranked by ideXlab platform
D. M. Barends - One of the best experts on this subject based on the ideXlab platform.
-
Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Quinidine Sulfate
Journal of pharmaceutical sciences, 2009Co-Authors: S. Grube, Peter Langguth, Hans E. Junginger, Sabine Kopp, Kamal K. Midha, Vinod P. Shah, Salomon A Stavchansky, Jennifer B. Dressman, D. M. BarendsAbstract:Literature data are reviewed relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of new multisource and reformulated immediate release (IR) solid oral dosage forms containing Quinidine Sulfate. Quinidine Sulfate's solubility and permeability, its therapeutic use and index, pharmacokinetics, excipient interactions and reported BE/bioavailability (BA) problems were taken into consideration. The available data are not fully conclusive, but do suggest that Quinidine Sulfate is highly soluble and moderately to highly permeable and would likely be assigned to BCS Class I (or at worst BCS III). In view of the inconclusiveness of the data and, more important, Quinidine's narrow therapeutic window and critical indication, a biowaiver based approval of Quinidine containing dosage forms cannot be recommended for either new multisource drug products or for major postapproval changes (variations) to existing drug products.
-
COMMENTARIES Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Quinidine Sulfate
2009Co-Authors: S. Grube, Peter Langguth, Sabine Kopp, Salomon A Stavchansky, D. M. Barends, Johannes Gutenberg-universityAbstract:Literature data are reviewed relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of new multisource and reformulated immediate release (IR) solid oral dosage forms containing Quinidine Sulfate. Quinidine Sulfate's solubility and permeability, its therapeutic use and index, pharmacokinetics, excipient interactions and reported BE/bioavailability (BA) problems were taken into consideration. The available data are not fully conclusive, but do suggest that Quinidine Sulfate is highly soluble and moderately to highly permeable and would likely be assigned to BCS Class I (or at worst BCS III). In view of the inconclusiveness of the data and, more important, Quinidine's narrow therapeutic window and critical indica- tion, a biowaiver based approval of Quinidine containing dosage forms cannot be recommended for either new multisource drug products or for major postapproval changes (variations) to existing drug products. 2008 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 98:2238-2251, 2009
S. Grube - One of the best experts on this subject based on the ideXlab platform.
-
Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Quinidine Sulfate
Journal of pharmaceutical sciences, 2009Co-Authors: S. Grube, Peter Langguth, Hans E. Junginger, Sabine Kopp, Kamal K. Midha, Vinod P. Shah, Salomon A Stavchansky, Jennifer B. Dressman, D. M. BarendsAbstract:Literature data are reviewed relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of new multisource and reformulated immediate release (IR) solid oral dosage forms containing Quinidine Sulfate. Quinidine Sulfate's solubility and permeability, its therapeutic use and index, pharmacokinetics, excipient interactions and reported BE/bioavailability (BA) problems were taken into consideration. The available data are not fully conclusive, but do suggest that Quinidine Sulfate is highly soluble and moderately to highly permeable and would likely be assigned to BCS Class I (or at worst BCS III). In view of the inconclusiveness of the data and, more important, Quinidine's narrow therapeutic window and critical indication, a biowaiver based approval of Quinidine containing dosage forms cannot be recommended for either new multisource drug products or for major postapproval changes (variations) to existing drug products.
-
COMMENTARIES Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Quinidine Sulfate
2009Co-Authors: S. Grube, Peter Langguth, Sabine Kopp, Salomon A Stavchansky, D. M. Barends, Johannes Gutenberg-universityAbstract:Literature data are reviewed relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of new multisource and reformulated immediate release (IR) solid oral dosage forms containing Quinidine Sulfate. Quinidine Sulfate's solubility and permeability, its therapeutic use and index, pharmacokinetics, excipient interactions and reported BE/bioavailability (BA) problems were taken into consideration. The available data are not fully conclusive, but do suggest that Quinidine Sulfate is highly soluble and moderately to highly permeable and would likely be assigned to BCS Class I (or at worst BCS III). In view of the inconclusiveness of the data and, more important, Quinidine's narrow therapeutic window and critical indica- tion, a biowaiver based approval of Quinidine containing dosage forms cannot be recommended for either new multisource drug products or for major postapproval changes (variations) to existing drug products. 2008 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 98:2238-2251, 2009
Peter Langguth - One of the best experts on this subject based on the ideXlab platform.
-
Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Quinidine Sulfate
Journal of pharmaceutical sciences, 2009Co-Authors: S. Grube, Peter Langguth, Hans E. Junginger, Sabine Kopp, Kamal K. Midha, Vinod P. Shah, Salomon A Stavchansky, Jennifer B. Dressman, D. M. BarendsAbstract:Literature data are reviewed relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of new multisource and reformulated immediate release (IR) solid oral dosage forms containing Quinidine Sulfate. Quinidine Sulfate's solubility and permeability, its therapeutic use and index, pharmacokinetics, excipient interactions and reported BE/bioavailability (BA) problems were taken into consideration. The available data are not fully conclusive, but do suggest that Quinidine Sulfate is highly soluble and moderately to highly permeable and would likely be assigned to BCS Class I (or at worst BCS III). In view of the inconclusiveness of the data and, more important, Quinidine's narrow therapeutic window and critical indication, a biowaiver based approval of Quinidine containing dosage forms cannot be recommended for either new multisource drug products or for major postapproval changes (variations) to existing drug products.
-
COMMENTARIES Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Quinidine Sulfate
2009Co-Authors: S. Grube, Peter Langguth, Sabine Kopp, Salomon A Stavchansky, D. M. Barends, Johannes Gutenberg-universityAbstract:Literature data are reviewed relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of new multisource and reformulated immediate release (IR) solid oral dosage forms containing Quinidine Sulfate. Quinidine Sulfate's solubility and permeability, its therapeutic use and index, pharmacokinetics, excipient interactions and reported BE/bioavailability (BA) problems were taken into consideration. The available data are not fully conclusive, but do suggest that Quinidine Sulfate is highly soluble and moderately to highly permeable and would likely be assigned to BCS Class I (or at worst BCS III). In view of the inconclusiveness of the data and, more important, Quinidine's narrow therapeutic window and critical indica- tion, a biowaiver based approval of Quinidine containing dosage forms cannot be recommended for either new multisource drug products or for major postapproval changes (variations) to existing drug products. 2008 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 98:2238-2251, 2009
Salomon A Stavchansky - One of the best experts on this subject based on the ideXlab platform.
-
Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Quinidine Sulfate
Journal of pharmaceutical sciences, 2009Co-Authors: S. Grube, Peter Langguth, Hans E. Junginger, Sabine Kopp, Kamal K. Midha, Vinod P. Shah, Salomon A Stavchansky, Jennifer B. Dressman, D. M. BarendsAbstract:Literature data are reviewed relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of new multisource and reformulated immediate release (IR) solid oral dosage forms containing Quinidine Sulfate. Quinidine Sulfate's solubility and permeability, its therapeutic use and index, pharmacokinetics, excipient interactions and reported BE/bioavailability (BA) problems were taken into consideration. The available data are not fully conclusive, but do suggest that Quinidine Sulfate is highly soluble and moderately to highly permeable and would likely be assigned to BCS Class I (or at worst BCS III). In view of the inconclusiveness of the data and, more important, Quinidine's narrow therapeutic window and critical indication, a biowaiver based approval of Quinidine containing dosage forms cannot be recommended for either new multisource drug products or for major postapproval changes (variations) to existing drug products.
-
COMMENTARIES Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Quinidine Sulfate
2009Co-Authors: S. Grube, Peter Langguth, Sabine Kopp, Salomon A Stavchansky, D. M. Barends, Johannes Gutenberg-universityAbstract:Literature data are reviewed relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of new multisource and reformulated immediate release (IR) solid oral dosage forms containing Quinidine Sulfate. Quinidine Sulfate's solubility and permeability, its therapeutic use and index, pharmacokinetics, excipient interactions and reported BE/bioavailability (BA) problems were taken into consideration. The available data are not fully conclusive, but do suggest that Quinidine Sulfate is highly soluble and moderately to highly permeable and would likely be assigned to BCS Class I (or at worst BCS III). In view of the inconclusiveness of the data and, more important, Quinidine's narrow therapeutic window and critical indica- tion, a biowaiver based approval of Quinidine containing dosage forms cannot be recommended for either new multisource drug products or for major postapproval changes (variations) to existing drug products. 2008 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 98:2238-2251, 2009
Sabine Kopp - One of the best experts on this subject based on the ideXlab platform.
-
Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Quinidine Sulfate
Journal of pharmaceutical sciences, 2009Co-Authors: S. Grube, Peter Langguth, Hans E. Junginger, Sabine Kopp, Kamal K. Midha, Vinod P. Shah, Salomon A Stavchansky, Jennifer B. Dressman, D. M. BarendsAbstract:Literature data are reviewed relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of new multisource and reformulated immediate release (IR) solid oral dosage forms containing Quinidine Sulfate. Quinidine Sulfate's solubility and permeability, its therapeutic use and index, pharmacokinetics, excipient interactions and reported BE/bioavailability (BA) problems were taken into consideration. The available data are not fully conclusive, but do suggest that Quinidine Sulfate is highly soluble and moderately to highly permeable and would likely be assigned to BCS Class I (or at worst BCS III). In view of the inconclusiveness of the data and, more important, Quinidine's narrow therapeutic window and critical indication, a biowaiver based approval of Quinidine containing dosage forms cannot be recommended for either new multisource drug products or for major postapproval changes (variations) to existing drug products.
-
COMMENTARIES Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Quinidine Sulfate
2009Co-Authors: S. Grube, Peter Langguth, Sabine Kopp, Salomon A Stavchansky, D. M. Barends, Johannes Gutenberg-universityAbstract:Literature data are reviewed relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of new multisource and reformulated immediate release (IR) solid oral dosage forms containing Quinidine Sulfate. Quinidine Sulfate's solubility and permeability, its therapeutic use and index, pharmacokinetics, excipient interactions and reported BE/bioavailability (BA) problems were taken into consideration. The available data are not fully conclusive, but do suggest that Quinidine Sulfate is highly soluble and moderately to highly permeable and would likely be assigned to BCS Class I (or at worst BCS III). In view of the inconclusiveness of the data and, more important, Quinidine's narrow therapeutic window and critical indica- tion, a biowaiver based approval of Quinidine containing dosage forms cannot be recommended for either new multisource drug products or for major postapproval changes (variations) to existing drug products. 2008 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 98:2238-2251, 2009
