Literature DB >> 18061880

The role of mechanism-based pharmacokinetic-pharmacodynamic (PK-PD) modelling in translational research of biologics.

Balaji M Agoram1, Steven W Martin, Piet H van der Graaf.   

Abstract

Lack of predictability of clinical efficacy and safety is an important problem facing pharmaceutical research today. Translational PK-PD has the ability to integrate data generated from diverse test platforms during discovery and development in a mechanistic framework. Therefore, successful implementation of translational PK-PD modelling and simulation early in the development cycle could have a substantial impact on overall efficiency and success of pharmaceutical research. Three case studies are presented, which outline successful implementation of the translational PK-PD methodology in the rational development of biotherapeutics across various stages of discovery and development. Emerging developments within the field are also discussed.

Mesh:

Substances:

Year:  2007        PMID: 18061880     DOI: 10.1016/j.drudis.2007.10.002

Source DB:  PubMed          Journal:  Drug Discov Today        ISSN: 1359-6446            Impact factor:   7.851


  62 in total

Review 1.  Prediction of exposure-response relationships to support first-in-human study design.

Authors:  John P Gibbs
Journal:  AAPS J       Date:  2010-10-22       Impact factor: 4.009

Review 2.  Use of quantitative pharmacology in the development of HAE1, a high-affinity anti-IgE monoclonal antibody.

Authors:  Wendy S Putnam; Jing Li; Jonas Haggstrom; Chee Ng; Saloumeh Kadkhodayan-Fischer; Melissa Cheu; Yamo Deniz; Henry Lowman; Paul Fielder; Jennifer Visich; Amita Joshi; Nelson Shasha Jumbe
Journal:  AAPS J       Date:  2008-08-07       Impact factor: 4.009

Review 3.  Pharmacokinetics and pharmacokinetic-pharmacodynamic correlations of therapeutic peptides.

Authors:  Lei Diao; Bernd Meibohm
Journal:  Clin Pharmacokinet       Date:  2013-10       Impact factor: 6.447

4.  Effect of antigen binding affinity and effector function on the pharmacokinetics and pharmacodynamics of anti-IgE monoclonal antibodies.

Authors:  Deborah L Mortensen; Saileta Prabhu; Eric G Stefanich; Saloumeh Kadkhodayan-Fischer; Thomas R Gelzleichter; Dana Baker; Jenny Jiang; Kristin Wallace; Suhasini Iyer; Paul J Fielder; Wendy S Putnam
Journal:  MAbs       Date:  2012 Nov-Dec       Impact factor: 5.857

Review 5.  Development of translational pharmacokinetic-pharmacodynamic models.

Authors:  D E Mager; W J Jusko
Journal:  Clin Pharmacol Ther       Date:  2008-03-26       Impact factor: 6.875

Review 6.  Using physiologically-based pharmacokinetic-guided "body-on-a-chip" systems to predict mammalian response to drug and chemical exposure.

Authors:  Jong Hwan Sung; Balaji Srinivasan; Mandy Brigitte Esch; William T McLamb; Catia Bernabini; Michael L Shuler; James J Hickman
Journal:  Exp Biol Med (Maywood)       Date:  2014-06-20

7.  From target selection to the minimum acceptable biological effect level for human study: use of mechanism-based PK/PD modeling to design safe and efficacious biologics.

Authors:  Jing Yu; Helene Karcher; Adam L Feire; Philip J Lowe
Journal:  AAPS J       Date:  2011-02-19       Impact factor: 4.009

8.  Use of pharmacokinetic/ pharmacodynamic modelling for starting dose selection in first-in-human trials of high-risk biologics.

Authors:  Balaji M Agoram
Journal:  Br J Clin Pharmacol       Date:  2008-12-11       Impact factor: 4.335

9.  Preclinical to Clinical Translation of Antibody-Drug Conjugates Using PK/PD Modeling: a Retrospective Analysis of Inotuzumab Ozogamicin.

Authors:  Alison M Betts; Nahor Haddish-Berhane; John Tolsma; Paul Jasper; Lindsay E King; Yongliang Sun; Subramanyam Chakrapani; Boris Shor; Joseph Boni; Theodore R Johnson
Journal:  AAPS J       Date:  2016-05-19       Impact factor: 4.009

Review 10.  Delivering systems pharmacogenomics towards precision medicine through mathematics.

Authors:  Yaqun Wang; Ningtao Wang; Jianxin Wang; Zhong Wang; Rongling Wu
Journal:  Adv Drug Deliv Rev       Date:  2013-03-22       Impact factor: 15.470

View more

北京卡尤迪生物科技股份有限公司 © 2022-2023.