Results 181 to 190 of about 2,897 (211)
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Journal of Pharmaceutical Sciences, 2020
Acid-reducing agents (ARAs) such as antacids, histamine-2 receptor antagonists, and proton pump inhibitors are widely prescribed in several disease states. In the case of a basic drug with pH-dependent solubility, concomitant administration with an ARA may reduce drug absorption and systemic exposure, potentially resulting in the loss of efficacy ...
Amitava, Mitra +7 more
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Acid-reducing agents (ARAs) such as antacids, histamine-2 receptor antagonists, and proton pump inhibitors are widely prescribed in several disease states. In the case of a basic drug with pH-dependent solubility, concomitant administration with an ARA may reduce drug absorption and systemic exposure, potentially resulting in the loss of efficacy ...
Amitava, Mitra +7 more
openaire +4 more sources
AAPS PharmSciTech, 2023
Dissolution is considered as a critical input into physiologically based biopharmaceutics models (PBBM) as it governs in vivo exposure. Despite many workshops, initiatives by academia, industry, and regulatory, wider practices are followed for dissolution data input into PBBM models.
Sivacharan Kollipara +4 more
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Dissolution is considered as a critical input into physiologically based biopharmaceutics models (PBBM) as it governs in vivo exposure. Despite many workshops, initiatives by academia, industry, and regulatory, wider practices are followed for dissolution data input into PBBM models.
Sivacharan Kollipara +4 more
openaire +2 more sources
The AAPS Journal, 2023
Physiologically based pharmacokinetic and absorption modeling has increasingly been implemented for biopharmaceutics applications to define the safe space for drug product quality attributes such as dissolution. For fevipiprant/QAW039, simulations were performed to assess the impact of in vitro dissolution on the in vivo performance of immediate ...
Alexandros, Kourentas +8 more
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Physiologically based pharmacokinetic and absorption modeling has increasingly been implemented for biopharmaceutics applications to define the safe space for drug product quality attributes such as dissolution. For fevipiprant/QAW039, simulations were performed to assess the impact of in vitro dissolution on the in vivo performance of immediate ...
Alexandros, Kourentas +8 more
openaire +2 more sources
Molecular Pharmaceutics, 2023
Acalabrutinib maleate tablets correspond to an improved formulation compared to acalabrutinib capsules as they can be dosed with and without acid reducing agents and therefore benefit more cancer patients. The dissolution specification for the drug product was determined using all the information available on the drug safety, efficacy, and in vitro ...
Xavier Pepin +3 more
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Acalabrutinib maleate tablets correspond to an improved formulation compared to acalabrutinib capsules as they can be dosed with and without acid reducing agents and therefore benefit more cancer patients. The dissolution specification for the drug product was determined using all the information available on the drug safety, efficacy, and in vitro ...
Xavier Pepin +3 more
openaire +2 more sources
Journal of Pharmaceutical Sciences, 2023
The use of physiologically based biopharmaceutics modeling (PBBM) and bioequivalence safe space is increasingly common for immediate-release drug products. However, for extended-release (ER) formulations there are only a few examples of this application. In this study, we developed ER formulations containing cyclobenzaprine 15 mg, supported by PBBM and
Everton Miranda dos Santos +3 more
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The use of physiologically based biopharmaceutics modeling (PBBM) and bioequivalence safe space is increasingly common for immediate-release drug products. However, for extended-release (ER) formulations there are only a few examples of this application. In this study, we developed ER formulations containing cyclobenzaprine 15 mg, supported by PBBM and
Everton Miranda dos Santos +3 more
openaire +2 more sources
European Journal of Pharmaceutics and Biopharmaceutics, 2020
Over the years, a wide variety of nanomedicines has entered global markets, providing a blueprint for the emerging generics industry. They are characterized by a unique pharmacokinetic behavior difficult to explain with conventional methods. In the present approach a physiologically-based nanocarrier biopharmaceutics model has been developed. Providing
Shakti, Nagpal +7 more
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Over the years, a wide variety of nanomedicines has entered global markets, providing a blueprint for the emerging generics industry. They are characterized by a unique pharmacokinetic behavior difficult to explain with conventional methods. In the present approach a physiologically-based nanocarrier biopharmaceutics model has been developed. Providing
Shakti, Nagpal +7 more
openaire +2 more sources
Journal of Pharmaceutical Sciences, 2021
This report summarizes the proceedings for Day 3 of the workshop titled "Current State and Future Expectations of Translational Modeling Strategies toSupportDrug Product Development, Manufacturing Changes and Controls". From a drug product quality perspective, patient-centric product development necessitates the development of clinically relevant drug ...
Amitava, Mitra +26 more
openaire +2 more sources
This report summarizes the proceedings for Day 3 of the workshop titled "Current State and Future Expectations of Translational Modeling Strategies toSupportDrug Product Development, Manufacturing Changes and Controls". From a drug product quality perspective, patient-centric product development necessitates the development of clinically relevant drug ...
Amitava, Mitra +26 more
openaire +2 more sources
The AAPS Journal, 2023
Quality risk assessment following ICH Q9 principles is an important activity to ensure optimal clinical efficacy and safety of a drug product. Typically, risk assessment is focused on product performance wherein critical material attributes, formulation variables, and process parameters are evaluated from a manufacturing perspective.
Tausif Ahmed +3 more
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Quality risk assessment following ICH Q9 principles is an important activity to ensure optimal clinical efficacy and safety of a drug product. Typically, risk assessment is focused on product performance wherein critical material attributes, formulation variables, and process parameters are evaluated from a manufacturing perspective.
Tausif Ahmed +3 more
openaire +2 more sources
Journal of Pharmaceutical Sciences, 2022
Weakly basic compounds propose biopharmaceutics risks due to the possibility of precipitation out of solution when passing from the stomach to the intestine. This behavior would limit the available drug for absorption and in turn reduces the plasma exposure at dose escalation scenarios in phase 1 clinical trials.
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Weakly basic compounds propose biopharmaceutics risks due to the possibility of precipitation out of solution when passing from the stomach to the intestine. This behavior would limit the available drug for absorption and in turn reduces the plasma exposure at dose escalation scenarios in phase 1 clinical trials.
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Biopharmaceutics & Drug Disposition, 2023
AbstractModel‐informed drug development is an important area recognized by regulatory authorities and is gaining increasing interest from the generic drug industry. Physiologically based biopharmaceutics modeling (PBBM) is a valuable tool to support drug development and bioequivalence assessments.
Frederico, Severino Martins +4 more
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AbstractModel‐informed drug development is an important area recognized by regulatory authorities and is gaining increasing interest from the generic drug industry. Physiologically based biopharmaceutics modeling (PBBM) is a valuable tool to support drug development and bioequivalence assessments.
Frederico, Severino Martins +4 more
openaire +2 more sources