Sep15 MIDD Guidance by Chinese NMPA
On August 3, 2020, China’s National Medical Products Administration (NMPA) announced Draft Technical Guidelines for Model-informed Drug Development (MIDD) . This document provides guidance on the rational use of MIDD to promote innovation and efficient drug development in China. This is a welc... Read More..
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... Read More..
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... Read More..
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... Read More..
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... Read More..
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... Read More..
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... Read More..
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 ... Read More..
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... Read More..
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... Read More..