Maria Malamatari
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View article: Altuvoct: Innovative Medicinal Products Benefit from Innovative Approaches to Regulatory Assessment
Altuvoct: Innovative Medicinal Products Benefit from Innovative Approaches to Regulatory Assessment Open
Efanesoctocog alfa (Altuvoct; BIVV001) is a fusion protein comprising domains of (i) factor VIII, (ii) the von Willebrand factor, and (iii) IgG1 coupled to two polypeptide linkers. The half-life of efanesoctocog alfa in plasma is about 40 …
View article: Current State and New Horizons in Applications of Physiologically Based Biopharmaceutics Modeling (PBBM): A Workshop Report
Current State and New Horizons in Applications of Physiologically Based Biopharmaceutics Modeling (PBBM): A Workshop Report Open
This report summarizes the proceedings for Day 3 of the workshop titled "Physiologically Based Biopharmaceutics Modeling (PBBM) Best Practices for Drug Product Quality: Regulatory and Industry Perspectives". This day focused on the current…
View article: Updates on the conversion of nanosuspensions to solid oral dosage forms
Updates on the conversion of nanosuspensions to solid oral dosage forms Open
Pharmaceutical nanosuspensions, also called nanocrystals, are heterogeneous mainly aqueous dispersions of insoluble drug particles stabilised by surfactants and/or polymers. Nanosuspensions as liquid formulations suffer from instability. S…
View article: Evaluation of mathematical models for predicting medicine distribution into breastmilk - considering biological heterogeneity
Evaluation of mathematical models for predicting medicine distribution into breastmilk - considering biological heterogeneity Open
Introduction A significant proportion of mothers take medication during the breastfeeding period, however knowledge of infant safety during continued breastfeeding is often limited. Breastmilk exhibits significant physiological heterogenei…
View article: Investigation of a fully mechanistic physiologically based pharmacokinetics model of absorption to support predictions of milk concentrations in breastfeeding women and the exposure of infants: A case study for albendazole
Investigation of a fully mechanistic physiologically based pharmacokinetics model of absorption to support predictions of milk concentrations in breastfeeding women and the exposure of infants: A case study for albendazole Open
Due to limited non‐clinical and clinical data, European guidance recommends to discontinue breastfeeding when taking albendazole. The aim of this study was to consider the use of PBPK modeling to support the expected exposure in breastfed …
View article: PBBM Considerations for Base Models, Model Validation, and Application Steps: Workshop Summary Report
PBBM Considerations for Base Models, Model Validation, and Application Steps: Workshop Summary Report Open
The proceedings from the 30th August 2023 (Day 2) of the workshop "Physiologically Based Biopharmaceutics Models (PBBM) Best Practices for Drug Product Quality: Regulatory and Industry Perspectives" are provided herein. Day 2 covered PBBM …
View article: Parameterization of Physiologically Based Biopharmaceutics Models: Workshop Summary Report
Parameterization of Physiologically Based Biopharmaceutics Models: Workshop Summary Report Open
This Article shares the proceedings from the August 29th, 2023 (day 1) workshop "Physiologically Based Biopharmaceutics Modeling (PBBM) Best Practices for Drug Product Quality: Regulatory and Industry Perspectives". The focus of the day wa…
View article: Physiologically Based Biopharmaceutics Modeling (PBBM): Best Practices for Drug Product Quality, Regulatory and Industry Perspectives: 2023 Workshop Summary Report
Physiologically Based Biopharmaceutics Modeling (PBBM): Best Practices for Drug Product Quality, Regulatory and Industry Perspectives: 2023 Workshop Summary Report Open
Physiologically based biopharmaceutics modeling (PBBM) is used to elevate drug product quality by providing a more accurate and holistic understanding of how drugs interact with the human body. These models are based on the integration of …
View article: Inhaled theophylline: old drug new tricks?
Inhaled theophylline: old drug new tricks? Open
Theophylline and aminophylline (i.e., the soluble complex of theophylline with ethylenediamine) have been used in the treatment of respiratory diseases such as asthma and chronic obstructive pulmonary disease for more than 90 years. Theoph…
View article: The Importance of Drug Delivery in the Clinical Development and Lifecycle of Drug Products with Examples from Authorised Medicinal Products
The Importance of Drug Delivery in the Clinical Development and Lifecycle of Drug Products with Examples from Authorised Medicinal Products Open
Drug delivery systems (DDS) are formulations or devices that enable the introduction of a therapeutic into the body and its delivery to its target site, potentially enhancing its efficacy and safety. Advances in formulation approaches rela…
View article: Spray Drying for the Preparation of Nanoparticle-Based Drug Formulations as Dry Powders for Inhalation
Spray Drying for the Preparation of Nanoparticle-Based Drug Formulations as Dry Powders for Inhalation Open
Nanoparticle-based therapeutics have been used in pulmonary formulations to enhance delivery of poorly water-soluble drugs, protect drugs against degradation and achieve modified release and drug targeting. This review focuses on the use o…
View article: Pharmaceutical Cocrystals: New Solid Phase Modification Approaches for the Formulation of APIs
Pharmaceutical Cocrystals: New Solid Phase Modification Approaches for the Formulation of APIs Open
Cocrystals can be used as an alternative approach based on crystal engineering to enhance specific physicochemical and biopharmaceutical properties of active pharmaceutical ingredients (APIs) when the approaches to salt or polymorph format…