0000000000425128

AUTHOR

Naseem A. Charoo

showing 4 related works from this author

Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Sitagliptin Phosphate Monohydrate

2021

Sitagliptin is an antihyperglycemic drug used in adults for the treatment of diabetes Type 2. Literature data and in-house experiments were applied in this monograph to assess whether methods based on the Biopharmaceutics Classification System (BCS) could be used to assess the bioequivalence of solid immediate-release (IR) oral dosage forms containing sitagliptin phosphate monohydrate, as an alternative to a pharmacokinetic study in human volunteers. The solubility and permeability characteristics of sitagliptin were reviewed according to the BCS, along with dissolution, therapeutic index, therapeutic applications, pharmacokinetics, pharmacodynamic characteristics, reports of bioequivalence…

Dosage FormsDrugbusiness.industrymedia_common.quotation_subjectSitagliptin PhosphateAdministration OralBiological AvailabilityPharmaceutical SciencePharmacologyBioequivalenceBiopharmaceutics Classification SystemPermeabilityDosage formBiopharmaceuticsBioavailabilitySolubilityTherapeutic EquivalencyPharmacokineticsSitagliptinPharmacodynamicsmedicineHumansbusinessmedicine.drugmedia_commonJournal of Pharmaceutical Sciences
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Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Moxifloxacin Hydrochloride.

2020

Abstract In this monograph, literature data is reviewed to evaluate the feasibility of waiving in vivo bioequivalence testing and instead applying the Biopharmaceutics Classification System (BCS) based methods to the approval of immediate-release solid oral dosage forms containing moxifloxacin hydrochloride as the sole active pharmaceutical ingredient. To facilitate the feasibility decision, solubility and permeability and dissolution characteristics in the context of the BCS, therapeutic index, therapeutic use, pharmacokinetic parameters, bioequivalence/bioavailability issues, drug-excipient interactions and other relevant data were taken into consideration. Moxifloxacin is a BCS class I d…

Break pointBiowaiverMoxifloxacinPharmaceutical ScienceAdministration OralBiological AvailabilityContext (language use)02 engineering and technologyPharmacologyBioequivalenceMoxifloxacin hydrochloride030226 pharmacology & pharmacyDosage formMoxifloxacin hydrochloridePermeabilityBiopharmaceutics03 medical and health sciences0302 clinical medicineMoxifloxacinMedicinePharmacokineticsTherapeutic indexActive ingredientDosage Formsbusiness.industryBiopharmaceutics Classification System021001 nanoscience & nanotechnologyBiopharmaceutics Classification SystemBioavailabilityPharmacodynamicsSolubilityTherapeutic Equivalency0210 nano-technologybusinessmedicine.drugJournal of pharmaceutical sciences
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Biowaiver monograph for immediate-release solid oral dosage forms: fluconazole.

2014

Literature data pertaining to the decision to allow a waiver of in vivo bioequivalence (BE) testing requirements for the approval of immediate release (IR) solid oral dosage forms containing fluconazole as the only active pharmaceutical ingredient (API) are reviewed. The decision is based on solubility, dissolution, permeability, therapeutic index, pharmacokinetic parameters, pharmacodynamic properties, and other relevant data. BE/bioavailability (BA) problems and drug-excipients interaction data were also reviewed and taken into consideration. According to the biopharmaceutics classification system (BCS), fluconazole in polymorphic forms II and III is a BCS class I drug and has a wide ther…

DrugMalemedia_common.quotation_subjectChemistry PharmaceuticalPharmaceutical ScienceAdministration OralBiological AvailabilityPharmacologyBioequivalenceDosage formPermeabilityBiopharmaceuticsExcipientsPharmacokineticsmedicineHumansFluconazolemedia_commonRandomized Controlled Trials as TopicActive ingredientDosage FormsCross-Over StudiesChemistryBiopharmaceutics Classification SystemBioavailabilitySolubilityTherapeutic EquivalencyFemaleFluconazolemedicine.drugJournal of pharmaceutical sciences
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Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Bisoprolol Fumarate

2014

Abstract Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate-release (IR) solid oral dosage forms containing bisoprolol as the sole active pharmaceutical ingredient (API) are reviewed. Bisoprolol is classified as a Class I API according to the current Biopharmaceutics Classification System (BCS). In addition to the BCS class, its therapeutic index, pharmacokinetic properties, data related to the possibility of excipient interactions, and reported BE/bioavailability problems are taken into consideration. Qualitative compositions of IR tablet dosage forms of bisoprolol with a marketing authorization (MA) in ICH (Inter…

Bisoprolol FumarateCell Membrane PermeabilityAdrenergic beta-AntagonistsBiological AvailabilityPharmaceutical ScienceExcipientPharmacologyBioequivalenceDosage formBiopharmaceuticsExcipientsmedicineBisoprololHumansTissue DistributionBiotransformationChromatography High Pressure LiquidHeart FailureActive ingredientChemistryStereoisomerismHydrogen-Ion ConcentrationBiopharmaceutics Classification SystemBioavailabilityIntestinal AbsorptionSolubilityTherapeutic EquivalencyBisoprololmedicine.drugJournal of Pharmaceutical Sciences
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