Mar12 Can Machine Learning Improve Traditional Modeling Approaches in Clinical Pharmacology?

Machine learning (ML) and, specifically, deep learning (DL) algorithms are increasingly being used in the biological and health sciences to build predictive algorithms and to find associations between predictive features and outcomes. Examples of ML/DL applications are plentiful in areas as diverse...
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Feb25 Announcing CPT: Pharmacometrics & System Pharmacology 2.0

After taking over the role of Editor-in-Chief of  CPT: Pharmacometrics & Systems Pharmacology  ( PSP )  in October 2018, one of my first tasks was to settle on a new editorial team. It is my distinct pleasure to present the team now: Lena Friberg, PhD, of Uppsala University has agreed to ...
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Dec21 Model-Informed Drug Development and Regulation in China

CPT: Pharmacometrics & Systems Pharmacology  ( PSP ) welcomes the first model-informed drug development (MiDD)  perspective  from China’s National Medical Products Administration (NMPA, former China FDA) to join the journal’s regulatory MiDD article family. The article  Model-Informed Drug De...
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Nov16 A Unique Collection of State-of-the-Art Pharmacometric and Systems Pharmacology Approaches in Rare Diseases Pharmacology and Therapeutics

Collectively, rare diseases represent a large medical challenge. With approximately 7,000 rare diseases, from cancers to inherited metabolic diseases and many exclusively in children, they present a significant unmet medical need. It is estimated that 350 million people worldwide suffer from rare d...
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Oct24 Recent Guidance on Physiologically Based Pharmacokinetic Models: Heralding Standardization and Consistency in Submissions

On September 3, 2018, the US Food and Drug Administration (FDA) finalized its first  PBPK guidance :  Physiologically Based Pharmacokinetic Analyses — Format and Content  following the draft guidance in December 2016. The guidance followed key workshops hosted by the  FDA  and European Me...
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Aug06 Quantitative Systems Pharmacology (QSP) and Physiologically Based Pharmacokinetics (PBPK) at the 2019 ASCPT Annual Meeting

The ASCPT Scientific Program Committee met a couple of weeks ago to finalize the program for the  2019 Annual Meeting with the theme “From Molecule to Patient."  It will be no surprise that quantitative, model-based approaches will be a main feature in various sessions. We would like to encoura...
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May31 The Increasing Role of Systems Pharmacology, Biomarkers and Disease Progression Models in Developing Drugs for the Treatment of Rare Diseases

Rare diseases collectively represent a large medical challenge. With approximately 7,000 r are diseases, which include rare cancers to inherited metabolic disease and many exclusively in children, they present a significant unmet medical need.  It is estimated that 350 million people worldwide su...
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Apr19 MiDD Pilot Program: An Opportunity to Expedite Pediatric Drug Development

On April 17, 2018, the US FDA announced the  Model-Informed Drug Development Pilot Program . The program fulfills one of the agency’s  performance goals  under its 6 th  iteration of the Prescription Drug User Fee Act (DUFA VI, 2018-2022), which recognizes the importance of  model-informed d...
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Apr18 Revisiting PBPK Predictability Following FDA's Introduction of M&S in Its Pediatric Guidance

On April 11, 2018 the US FDA published a new Guidance for Industry  “ ICH E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population ,” introducing the role of modeling and simulations (M&S) in pediatric drug development.    The addendum appears to expect that s...
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Mar30 Lung Themed Virtual Issue

The lung is an unusual organ from the perspective of drug delivery, since it is amenable to local administration. This concept has been successfully translated to clinical practice in pulmonary disease areas like asthma and chronic obstructive pulmonary disease (COPD). Physiologically-based pharma...
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