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Review: Role of Model-Informed Drug Development Approaches in the Lifecycle of Drug Development and Regulatory Decision-Making
Model-informed drug development (MIDD) is a powerful approach to support drug development and regulatory review. There is a rich history of MIDD...
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Model-Informed Clinical Development of Once-Every-6-Month Injection of Paliperidone Palmitate in Patients with Schizophrenia: A Pharmacometric Bridging Approach (Part I)
Background and ObjectiveA model-informed drug development (MIDD) approach was implemented for paliperidone palmitate (PP) 6-month (PP6M) clinical...
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A Perspective on Model-Informed IVIVC for Development of Subcutaneous Injectables
Subcutaneously administered drugs are growing in popularity for both large and small molecule drugs. However, development of these systems –...
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The Genetically Informed Neurobiology of Addiction (GINA) model
Addictions are heritable and unfold dynamically across the lifespan. One prominent neurobiological theory proposes that substance-induced changes in...
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An industry perspective on current QSP trends in drug development
2023 marks the 10th anniversary of Natpara’s submission to the US FDA, which led to the first recorded regulatory interaction where a decision was...
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An AI Approach to Generating MIDD Assets Across the Drug Development Continuum
Model-informed drug development involves develo** and applying exposure-based, biological, and statistical models derived from preclinical and...
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Role of Modeling and Simulation in Preclinical and Clinical Long-Acting Injectable Drug Development
Innovations in the field of long-acting injectable drug development are increasingly being reported. More advanced in vitro and in vivo ...
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Drug Development for New Psychiatric Drug Therapies
Drug development is an expensive, high risk, and highly regulated process. Only about 6.2% of new molecules tested for mental disorders eventually...
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Applications of Modeling and Simulation Approaches in Support of Drug Product Development of Oral Dosage Forms and Locally Acting Drug Products: a Symposium Summary
The number of modeling and simulation applications, including physiologically based pharmacokinetic (PBPK) models, physiologically based...
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AI: Catalyst for Drug Discovery and Development
This abstract explores the multifaceted roles of AI in expediting the drug development process. AI-driven algorithms analyze vast datasets,...
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Artificial Intelligence in Drug Discovery and Development
This chapter comprehensively explores the pivotal role of artificial intelligence (AI) in drug discovery and development, encapsulating its...
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Model-Informed Approach Supporting Approval of Nexviazyme (Avalglucosidase Alfa-ngpt) in Pediatric Patients with Late-Onset Pompe Disease
In August 2021, the US Food and Drug Administration approved Nexviazyme (avalglucosidase alfa-ngpt) for intravenous infusion to treat patients 1 year...
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Individualized Patient Care Through Model-Informed Precision Dosing: Reflections on Training Future Practitioners
Prior to his passing, Dr. Roger Jelliffe, expressed the need for educating future physicians and clinical pharmacists on the availability of...
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Membrane transporters in drug development and as determinants of precision medicine
The effect of membrane transporters on drug disposition, efficacy and safety is now well recognized. Since the initial publication from the...
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Transforming Drug Development for Neurological Disorders: Proceedings from a Multidisease Area Workshop
Neurological disorders represent some of the most challenging therapeutic areas for successful drug approvals. The escalating global burden of death...
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The Role of fMRI in Drug Development: An Update
Functional magnetic resonance imaging (fMRI) of the brain is a technology that holds great potential for increasing the efficiency of drug...
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Model-Informed Approach Supporting Approval of Adalimumab (HUMIRA) in Pediatric Patients with Ulcerative Colitis from a Regulatory Perspective
On February 24, 2021, the U.S. Food and Drug Administration (FDA) approved an efficacy supplement for HUMIRA® (adalimumab) injection to expand the...
