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its first  PBPK guidance :  Physiologically Based Pharmacokinetic Analyses — Format and Content  following the draft guidance in December 2016.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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Feb22 Preclinical QSP Modeling in the Pharmaceutical Industry

The cost of developing drugs is rising rapidly, and the number of new drug approvals per dollar spent showed a decline over the last decades. Approximately 90% of investigational drugs fail before being approved for use in patients, mostly attributed to either lack of efficacy or to drug-induced sa...
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Jan26 The Proof Is in the Pee: Crowdsourcing for Hands-on Teaching of Clinical Pharmacology

Does your pee stink after eating asparagus? In many people, eating asparagus is associated with the production of malodorous urine. A team convened at the  American Society for Clinical Pharmacology and Therapeutics (ASCPT)  to use this observation to better understand urinary odor kinetics after co...
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