Monoclonal antibodies are increasingly being developed to treat multiple disease areas, including those related to oncology, immunology, neurology, and ophthalmology. There are multiple factors, such as charge, size, neo...
Recently, there has been increased interest in extending the provision for waivers of in vivo bioavailability and bioequivalence (BA–BE) studies that appeared in the guidance published by the Food and Drug Admini...
It has been reported that the toxicity of carmustine (BCNU) cyclophosphamide (CY)/etoposide regimen (when BCNU is split into 4 doses) is less than that of BCNU/CY/cisplatin regimen (when the same amount of BCNU is admini...
Physiochemical and Biochemical Factors Influencing the Pharmacokinetics of Antibody Therapeutics
Monoclonal antibodies are increasingly being developed to treat multiple disease areas, including those related to oncology, immunology, neurology, and ophthalmology. There are multiple factors, such as charge, size, neo...
Scientific Perspectives on Extending the Provision for Waivers of In vivo Bioavailability and Bioequivalence Studies for Drug Products Containing High Solubility-Low Permeability Drugs (BCS-Class 3)
Recently, there has been increased interest in extending the provision for waivers of in vivo bioavailability and bioequivalence (BA–BE) studies that appeared in the guidance published by the Food and Drug Admini...
Inhibition of carboxyethylphosphoramide mustard formation from 4-hydroxycyclophosphamide by carmustine
It has been reported that the toxicity of carmustine (BCNU) cyclophosphamide (CY)/etoposide regimen (when BCNU is split into 4 doses) is less than that of BCNU/CY/cisplatin regimen (when the same amount of BCNU is admini...
Erratum to: Pharmacokinetic and Pharmacodynamic Analysis of Hyperthermic Intraperitoneal Oxaliplatin-Induced Neutropenia in Subjects with Peritoneal Carcinomatosis
The online version of the original article can be found at http://dx.doi.org/10.1208/s12248-010-9249-2.
Reference Datasets for 2-Treatment, 2-Sequence, 2-Period Bioequivalence Studies
The online version of this article (doi:10.1208/s12248-014-9661-0) contains supplementary material, which is available to authorized users.