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Aug29 Advancing the Use of Mathematical and Computational Approaches in Drug Development

Many readers of  PSP  are members of  the International Society of Pharmacometrics (ISoP) . Those who are not members are at least likely to be familiar with the society’s activities, such as the American Conference on Pharmacometrics (ACoP). Even readers who are active members of the society...
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Jul12 Two NONMEM Tutorials in PSP!

NONMEM remains the most widely used software for population PK and PKD analyses, both within academia and in pharmaceutical industry. I believe the continuous development to include features requested by users, and various contributions to the pharmacometrics community, are part of the continued su...
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Jun25 ASCPT 2019 Annual Meeting Pre-conferences

The June 2019 issue of  PSP  is dedicated to articles contributed by the ASCPT 2019 Annual Meeting Pre-Conference speakers and organizers of “ PBPK (Physiologically-based Pharmacokinetic) Modeling for the Development and Approval of Locally Acting Drug Products ” and “ Advancing QSP (Quantit...
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May30 Establishing Reproducibility of Quantitative Systems Pharmacology Models

As the use of quantitative systems pharmacology (QSP) models is seeing widespread models – the publication by  Kirouac et al., 2019 raises the issue of reproducibility . The authors conducted a survey of published models ( see Table 1, Kirouac et al., 2019 ) and found that after evaluating 12 m...
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Apr24 Barriers to Unleashing the Full Potential of Model-Informed Drug Development

A recent industry perspective by Jain, et al. identified barriers to unleashing the full potential of Model-informed Drug Development (MIDD). The barriers fall into two categories: the lack of acceptance by key stake holders, and the lack of consensus in standards among global regulators. In t...
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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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