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Survey Outcome on Immunogenicity Risk Assessment Tools for Biotherapeutics: an Insight into Consensus on Methods, Application, and Utility in Drug Development
Survey Outcome on Immunogenicity Risk Assessment Tools for Biotherapeutics: an Insight into Consensus on Methods, Application, and Utility in Drug Development
A survey conducted by the Therapeutic Product Immunogenicity (TPI) community within the American Association of Pharmaceut...
Population-Based Pharmacodynamic Modeling of Omalizumab in Pediatric Patients with Moderate to Severe Persistent Inadequately Controlled Allergic Asthma
Population-Based Pharmacodynamic Modeling of Omalizumab in Pediatric Patients with Moderate to Severe Persistent Inadequately Controlled Allergic Asthma
Omalizumab is the first approved anti-immunoglobulin E (IgE) agent for the treatment of moderate to severe persistent inad...
Anti-melanoma Effects of Resiquimod (RSQ) In Vitro and in Combination with Immune Checkpoint Blockade In Vivo
Anti-melanoma Effects of Resiquimod (RSQ) In Vitro and in Combination with Immune Checkpoint Blockade In Vivo
Melanoma is the deadliest form of skin cancer and surgery is currently the most effective treatment. However, there are si...
Impact of Organ Impairment on the Pharmacokinetics of Therapeutic Peptides and Proteins
Impact of Organ Impairment on the Pharmacokinetics of Therapeutic Peptides and Proteins
The kidneys and liver are major organs involved in eliminating small-molecule drugs from the body. Characterization of the...
Predicting Human Bioavailability of Subcutaneously Administered Monoclonal Antibodies Using Non-human Primate Linear Clearance and Antibody Isoelectric Point
Predicting Human Bioavailability of Subcutaneously Administered Monoclonal Antibodies Using Non-human Primate Linear Clearance and Antibody Isoelectric Point
The prediction of bioavailability is one of the major barriers in the clinical translation of subcutaneously (SC) administ...
Micellar Encapsulation of Propofol Reduces its Adsorption on Extracorporeal Membrane Oxygenator (ECMO) Circuit
Micellar Encapsulation of Propofol Reduces its Adsorption on Extracorporeal Membrane Oxygenator (ECMO) Circuit
Extracorporeal membrane oxygenation (ECMO) is a life-saving cardiopulmonary bypass device used on critically ill patients ...
Amgen v. Sanofi: Critical Impact on the Value of Innovative Science in Antibody Discovery
Amgen v. Sanofi: Critical Impact on the Value of Innovative Science in Antibody Discovery
Conflict of Interest JPB has served as a consultant for sev...
A Precise qNMR Method for the Rapid Quantification of Lot-to-Lot Variations in Multiple Quality Attributes of Pentosan Polysulfate Sodium
A Precise qNMR Method for the Rapid Quantification of Lot-to-Lot Variations in Multiple Quality Attributes of Pentosan Polysulfate Sodium
Pentosan polysulfate sodium (PPS) is an orphan drug with anticoagulant activity. PPS is prepared from the chemical process...
Long-Acting Injectable Aqueous Suspensions—Summary From an AAPS Workshop
Long-Acting Injectable Aqueous Suspensions—Summary From an AAPS Workshop
Through many years of clinical application of long-acting injectables, there is clear proof that this type of formulation ...
Physiologically Based Pharmacokinetic Modeling to Characterize the Effect of Molecular Charge on Whole-Body Disposition of Monoclonal Antibodies
Physiologically Based Pharmacokinetic Modeling to Characterize the Effect of Molecular Charge on Whole-Body Disposition of Monoclonal Antibodies
Motivated by a series of work demonstrating the effect of molecular charge on antibody pharmacokinetics (PK), physiologica...
The Effect of Sampling Cannula on In Vitro Dissolution Testing with USP Paddle Method
The Effect of Sampling Cannula on In Vitro Dissolution Testing with USP Paddle Method
In vitro dissolution tests are widely used as quality control tools for drug products in development and manufacturing. Di...
Evaluation of Cellular Immune Response to Adeno-Associated Virus-Based Gene Therapy
Evaluation of Cellular Immune Response to Adeno-Associated Virus-Based Gene Therapy
The number of approved or investigational late phase viral vector gene therapies (GTx) has been rapidly growing. The adeno...
The AAPS Journal Theme Issue: Compendium of Immunogenicity Risk Assessments: an Industry Guidance Built on Experience and Published Work
The AAPS Journal Theme Issue: Compendium of Immunogenicity Risk Assessments: an Industry Guidance Built on Experience and Published Work
Rosenberg A, Worobec A. A risk-based approach to immunogenicity concerns of therapeutic protein products, Part 1: consider...
Quantitative Analysis of Gastrointestinal Water Dynamics by Means of a Physiologically Based Fluid Kinetic Model
Quantitative Analysis of Gastrointestinal Water Dynamics by Means of a Physiologically Based Fluid Kinetic Model
Since the processes of dissolution and membrane permeation are affected by the water content in the gastrointestinal (GI) ...
Dissolution Profile Similarity Assessment—Best Practices, Decision Trees and Global Harmonization
Dissolution Profile Similarity Assessment—Best Practices, Decision Trees and Global Harmonization
During the write-up of the meeting summary reports from the 2019 dissolution similarity workshop held at the University of...
Harmonizing Biopredictive Methodologies Through the Product Quality Research Institute (PQRI) Part I: Biopredictive Dissolution of Ibuprofen and Dipyridamole Tablets
Harmonizing Biopredictive Methodologies Through the Product Quality Research Institute (PQRI) Part I: Biopredictive Dissolution of Ibuprofen and Dipyridamole Tablets
Assessing in vivo performance to inform formulation selection and development decisions is an important aspect of drug dev...
In Vitro-In Vivo Extrapolation and Scaling Factors for Clearance of Human and Preclinical Species with Liver Microsomes and Hepatocytes
In Vitro-In Vivo Extrapolation and Scaling Factors for Clearance of Human and Preclinical Species with Liver Microsomes and Hepatocytes
In vitro-in vivo extrapolation ((IVIVE) and empirical scaling factors (SF) of human intrinsic clearance (CLint) were devel...
A Pharmacometrics Model to Characterize a New Type of Target-Mediated Drug Disposition (TMDD) – Nonlinear Pharmacokinetics of Small-Molecule PF-07059013 Mediated By Its High-capacity Pharmacological Target Hemoglobin With Positive Cooperative Binding
A Pharmacometrics Model to Characterize a New Type of Target-Mediated Drug Disposition (TMDD) – Nonlinear Pharmacokinetics of Small-Molecule PF-07059013 Mediated By Its High-capacity Pharmacological Target Hemoglobin With Positive Cooperative Binding
In general, small-molecule target-mediated drug disposition (TMDD) is caused by the interaction of a drug with its high-af...
The Uses and Advantages of Kirchhoff’s Laws vs. Differential Equations in Pharmacology, Pharmacokinetics, and (Even) Chemistry
The Uses and Advantages of Kirchhoff’s Laws vs. Differential Equations in Pharmacology, Pharmacokinetics, and (Even) Chemistry
In chemistry, rate processes are defined in terms of rate constants, with units of time−1, and are derived by differ...
Plasma Stability and Plasma Metabolite Concentration–Time Profiles of Oligo(Lactic Acid)8-Paclitaxel Prodrug Loaded Polymeric Micelles
Plasma Stability and Plasma Metabolite Concentration–Time Profiles of Oligo(Lactic Acid)8-Paclitaxel Prodrug Loaded Polymeric Micelles
Paclitaxel (PTX) is a frequently prescribed chemotherapy drug used to treat a wide variety of solid tumors. Oligo(lactic a...
Dependence of Bioavailability on Mean Absorption Time: What Does It Tell Us?
Dependence of Bioavailability on Mean Absorption Time: What Does It Tell Us?
The extent and rate of bioavailability are fundamental measures to characterize the pharmacokinetics of drugs after oral a...
Statistical Approaches for Establishing Appropriate Immunogenicity Assay Cut Points: Impact of Sample Distribution, Sample Size, and Outlier Removal
Statistical Approaches for Establishing Appropriate Immunogenicity Assay Cut Points: Impact of Sample Distribution, Sample Size, and Outlier Removal
The statistical assessments needed to establish anti-drug antibody (ADA) assay cut points (CPs) can be challenging for bio...
Comparison of Pre-existing Anti-AAV8 Total Antibody Screening and Confirmatory Assays with a Cell-Based Neutralizing Assay in Normal Human Serum
Comparison of Pre-existing Anti-AAV8 Total Antibody Screening and Confirmatory Assays with a Cell-Based Neutralizing Assay in Normal Human Serum
Pre-existing adeno-associated viruses (AAV) neutralizing antibodies (NAb) can prevent AAV vectors from transducing target ...
Predicting Food Effects on Oral Extended-Release Drug Products: A Retrospective Evaluation
Predicting Food Effects on Oral Extended-Release Drug Products: A Retrospective Evaluation
Theoretically, the risk of food effects for extended-release (ER) products compared to IR products may be less because: (1...
Correction: Preclinical In Vivo Data Integrated in a Modeling Network Informs a Refined Clinical Strategy for a CD3 T‑Cell Bispecific in Combination with Anti‑PD‑L1
Correction: Preclinical In Vivo Data Integrated in a Modeling Network Informs a Refined Clinical Strategy for a CD3 T‑Cell Bispecific in Combination with Anti‑PD‑L1
Cite this articleSánchez, J., Nicolini, V., Fahrni, L. et al. Correction: Preclinical In Vivo Data Integrated in a Modelin...
Leveraging Prior Healthy Participant Pharmacokinetic Data to Evaluate the Impact of Renal and Hepatic Impairment on Ritlecitinib Pharmacokinetics
Leveraging Prior Healthy Participant Pharmacokinetic Data to Evaluate the Impact of Renal and Hepatic Impairment on Ritlecitinib Pharmacokinetics
Ritlecitinib is a selective, covalent, irreversible inhibitor of Janus kinase 3 (JAK3) and the tyrosine kinase expressed i...
Development of Drug Release Model for Suspensions in ESCAR (Emulator of SubCutaneous Absorption and Release)
Development of Drug Release Model for Suspensions in ESCAR (Emulator of SubCutaneous Absorption and Release)
We recently developed an in vitro testing system, namely, ESCAR (Emulator of SubCutaneous Absorption and Release). The obj...
Virtual Bioequivalence Assessment of Elagolix Formulations Using Physiologically Based Pharmacokinetic Modeling
Virtual Bioequivalence Assessment of Elagolix Formulations Using Physiologically Based Pharmacokinetic Modeling
In lieu of large bioequivalence studies and exposing healthy postmenopausal women to additional drug exposure for elagolix...
Predicting Human Bioavailability of Subcutaneously Administered Fusion Proteins and Monoclonal Antibodies Using Human Intravenous Clearance or Antibody Isoelectric Point
Predicting Human Bioavailability of Subcutaneously Administered Fusion Proteins and Monoclonal Antibodies Using Human Intravenous Clearance or Antibody Isoelectric Point
There has been an increasing trend towards subcutaneous (SC) delivery of fusion proteins and monoclonal antibodies (mAbs) ...
The Prevalence of Several Treatments in Preventing the Back Conversion of Acyl Glucuronide Metabolites in Abbreviated New Drug Applications
The Prevalence of Several Treatments in Preventing the Back Conversion of Acyl Glucuronide Metabolites in Abbreviated New Drug Applications
The bioanalysis of drugs that undergo acyl glucuronidation presents an analytical challenge due to poor stability of acyl ...
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