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Role of Disease Progression Models in Drug Development
The use of Disease progression models (DPMs) in Drug Development has been widely adopted across therapeutic areas as a method for integrating...
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Navigating the complexities of drug development for inflammatory bowel disease
Inflammatory bowel disease (IBD) — consisting of ulcerative colitis and Crohn’s disease — is a complex, heterogeneous, immune-mediated inflammatory...
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Achieving big with small: quantitative clinical pharmacology tools for drug development in pediatric rare diseases
Pediatric populations represent a major fraction of rare diseases and compound the intrinsic challenges of pediatric drug development and drug...
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Experience Learned and Perspectives on Using Model-Integrated Evidence in the Regulatory Context for Generic Drug Products—a Meeting Report
This report summarizes relevant insights and discussions from a 2022 FDA public workshop titled Best Practices for Utilizing Modeling Approaches to...
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Applications of Model-Based Meta-Analysis in Drug Development
Model-based meta-analysis (MBMA) is a quantitative approach that leverages published summary data along with internal data and can be applied to...
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Advancing cancer drug development with mechanistic mathematical modeling: bridging the gap between theory and practice
Quantitative predictive modeling of cancer growth, progression, and individual response to therapy is a rapidly growing field. Researchers from...
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Model-Informed Clinical Development of 6-Monthly Injection of Paliperidone Palmitate in Patients with Schizophrenia: Dosing Strategies Guided by Population Pharmacokinetic Modeling and Simulation (Part II)
Background and ObjectivePaliperidone palmitate 6-month (PP6M) intramuscular (IM) injection is the longest-acting treatment available for patients...
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Modelling Based Approaches to Support Generic Drug Regulatory Submissions-Practical Considerations and Case Studies
Model informed drug development (MiDD) is useful to predict in vivo exposure of drugs during various stages of the drug development process. This...
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Evidence-Based Guidelines for Drug Interaction Studies: Model-Informed Time Course of Intestinal and Hepatic CYP3A4 Inhibition by Clarithromycin
Drug-drug interaction (DDI) studies are mandated in drug development; however, protocols for evaluating the impact of cytochrome P450 (CYP)...
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Pharmacokinetics and Pharmacodynamics: Fundamentals and Role(s) in Drug Discovery and Development
The process of finding new drugs begins with the identification of a target and its validation, then hits are found, leads are generated, and they...
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The History of Drug Development in Psychiatry: A Lesson in Serendipity
The goal of this book is to provide a guide on modern day drug development in psychiatry. However, in order to understand current practices in drug...
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The future of rare disease drug development: the rare disease cures accelerator data analytics platform (RDCA-DAP)
Rare disease drug development is wrought with challenges not the least of which is access to the limited data currently available throughout the rare...
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Patient-Derived Xenograft Models for Translational Prostate Cancer Research and Drug Development
Patient-derived xenografts (PDXs) are a valuable preclinical research platform generated through transplantation of a patient’s resected tumor into...
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Current State and Challenges of Physiologically Based Biopharmaceutics Modeling (PBBM) in Oral Drug Product Development
Physiologically based biopharmaceutics modeling (PBBM) emphasizes the integration of physicochemical properties of drug substance and formulation...
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Computational neurosciences and quantitative systems pharmacology: a powerful combination for supporting drug development in neurodegenerative diseases
Successful clinical development of new therapeutic interventions is notoriously difficult, especially in neurodegenerative diseases, where predictive...
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Doses Evaluated in Clinical Pharmacology Studies Investigating the Effect of Intrinsic and Extrinsic Factors on PK and Safety: Case Examples from Approved Drug Development Programs
Dose selection for investigations of intrinsic and extrinsic factors of pharmacokinetic variability as well as safety is a challenging question in...
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Rare oncology therapeutics: review of clinical pharmacology package of drug approvals (2019–2023) by US FDA, best practices and recommendations
There are many challenges with rare diseases drug development and rare oncology indications are not different. To understand the regulatory landscape...
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Dynamics of Drug Resistance
Drug resistance is an aspect of tumour progression, and is thus common in advanced tumours. Because drug resistance is readily measurable in...
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Future Directions and Challenges in Overcoming Drug Resistance in Cancer
The chapter Future Directions and Challenges in Overcoming Drug Resistance in Cancer explores crucial aspects, primarily focusing on two key topics:...