Industry Perspective - What does Industry Need to Accelerate Drug Product and Process Development? [PDF]
Pharm ResChatterjee B, Steiner R, Kaul G.
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A PBPK-VBE approach for bioequivalence extrapolation of senaparib capsule strengths in the context of nonlinear pharmacokinetics: bridging from the clinical starting dose to the linear pharmacokinetic range. [PDF]
Front PharmacolWu X +10 more
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Biowaiver Monograph for Immediate-Release Dosage Forms: Levamisole Hydrochloride
Journal of Pharmaceutical Sciences, 2023 This work describes the potential applicability of the BCS-based Biowaiver to oral solid dosage forms containing Levamisole hydrochloride, an anthelmintic drug on the WHO List of Essential Medicines. Solubility and permeability data of levamisole hydrochloride were searched in the literature and/or measured experimentally. Levamisole hydrochloride is a
Atsushi Kambayashi +11 more
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Justification of metformin hydrochloride biowaiver criteria based on bioequivalence study
Arzneimittelforschung, 2011 The Biopharmaceutics Classification System (BCS) represents the framework for predicting the intestinal drug absorption based on its solubility and intestinal permeability. Recent research has lead to the use of in vitro tests to waive additional in vivo bioequivalence studies for some pharmaceutical products (i.e., biowaiver).
Homšek, Irena +4 more
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Biowaiver monographs for immediate-release solid oral dosage forms: Voriconazole
Journal of Pharmaceutical SciencesAccording to the ICH M9 Guideline, the triazole antifungal voriconazole is a Biopharmaceutics Classification System (BCS) class II drug, being highly soluble at the highest dose strength but not at the highest single dose. Although the ICH M9 allows for consideration of BCS-based biowaivers in such cases, voriconazole does not meet the additional ...
Beran, Kristian +10 more
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Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Isavuconazonium Sulfate
Journal of Pharmaceutical Sciences386395A Biopharmaceutics Classification System (BCS)-based biowaiver monograph is presented for isavuconazonium sulfate. A BCS-based biowaiver is a regulatory option to substitute appropriate in vitro data for in vivo bioequivalence studies ...
Naseem A Charoo +2 more
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Investigation on the Possibility of Biowaivers for Ibuprofen
Journal of Pharmaceutical Sciences, 2011The aim of the study was to investigate the ability of in vitro dissolution to ensure bioequivalence of ibuprofen products. Ibuprofen is a Biopharmaceutics Classification System (BCS) class II drug with low solubility at pH 1.2 and 4.5 and high solubility at pH 6.8.
Covadonga, Alvarez +5 more
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On the Biopharmaceutics Classification System Biowaiver of Ibuprofen
Journal of Pharmaceutical Sciences, 20151Division of Pharmacology and Clinical Evaluation, Department of Human Use Medicines, Spanish Agency for Medicines and Health Care Products, Madrid, Spain 2Division of Biopharmaceutics Evaluation, Bureau of Pharmaceutical Sciences, Therapeutic Products Directorate, Health Canada, Ottawa, Canada 3Subdepartment of Biostatistics and Pharmacokinetics ...
Alfredo, García-Arieta +2 more
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The objective of the present work is to investigate the validity of the existing requirements for BCS biowaivers of immediate release products containing a class I drug in relation to the agitation rate (50 or 75 rpm in the paddle apparatus) and the time limit for complete dissolution (30 min) in the current biowaivers in vitro dissolution tests ...
Alfredo, Garcia-Arieta +5 more
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Biowaiver: an alternative to in vivo pharmacokinetic bioequivalence studies
Die Pharmazie, 2010Bioequivalence is a vital concern in drug development even more significant in the case of Narrow Thera-peutic Index (NTI) drugs. In clinical development of New Chemical Entities (NCE), bioequivalence studies necessitate to be performed when the formulation of the pharmaceutical dosage form has been changed.
Mishra, V., Gupta, U., Jain, N. K.
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