Literature DB >> 24548989

Next-generation medicines: past regulatory experience and considerations for the future.

M A Pacanowski1, C Leptak2, I Zineh1.   

Abstract

Application of personalized medicine in drug development and regulation has been limited by similar logistical, informatics, and cultural barriers that limit use of pharmacogenetics in the clinic. An additional challenge is coordinated codevelopment of new drugs and diagnostic tests. Nevertheless, the impact of personalized medicine strategies (e.g., pharmacogenomics) is being realized. We highlight some of our experiences to date and considerations for the development of the next generation of targeted therapies.

Mesh：

Year:  2014        PMID： 24548989     DOI： 10.1038/clpt.2013.222

Source DB:  PubMed          Journal:  Clin Pharmacol Ther        ISSN： 0009-9236            Impact factor:   6.875


  9 in total

Review 1.  Pharmacogenomic Biomarkers: an FDA Perspective on Utilization in Biological Product Labeling.

Authors:  Robert N Schuck; Joseph A Grillo
Journal:  AAPS J       Date:  2016-02-24       Impact factor: 4.009

Review 2.  Applications of pharmacogenomics in regulatory science: a product life cycle review.

Authors:  W C Tan-Koi; P C Leow; Y Y Teo
Journal:  Pharmacogenomics J       Date:  2017-12-05       Impact factor: 3.550

3.  Regulatory policy for the development of targeted therapies for low-frequency molecular subtypes of disease.

Authors:  Robert N Schuck; Michael Pacanowski; Janet Woodcock; Issam Zineh
Journal:  Nat Rev Drug Discov       Date:  2017-12-22       Impact factor: 84.694

Review 4.  Considerations for Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease.

Authors:  Robert N Schuck; Janet Woodcock; Issam Zineh; Peter Stein; Jonathan Jarow; Robert Temple; Thomas Permutt; Lisa LaVange; Julia A Beaver; Rosane Charlab; Gideon M Blumenthal; Sarah E Dorff; Christopher Leptak; Steven Lemery; Hobart Rogers; Badrul Chowdhury; E David Litwack; Michael Pacanowski
Journal:  Clin Pharmacol Ther       Date:  2018-02-23       Impact factor: 6.875

Review 5.  Leveraging Genomic Factors to Improve Benefit-Risk.

Authors:  R N Schuck; R Charlab; G M Blumenthal
Journal:  Clin Transl Sci       Date:  2017-02-03       Impact factor: 4.689

Review 6.  Precision Dosing: Public Health Need, Proposed Framework, and Anticipated Impact.

Authors:  Daniel Gonzalez; Gauri G Rao; Stacy C Bailey; Kim L R Brouwer; Yanguang Cao; Daniel J Crona; Angela D M Kashuba; Craig R Lee; Kathryn Morbitzer; J Herbert Patterson; Tim Wiltshire; Jon Easter; Scott W Savage; J Robert Powell
Journal:  Clin Transl Sci       Date:  2017-08-10       Impact factor: 4.689

7.  Pharmacogenomics Implementation and Hurdles to Overcome; In the Context of a Developing Country.

Authors:  Nayyereh Ayati; Monireh Afzali; Mandana Hasanzad; Abbas Kebriaeezadeh; Ali Rajabzadeh; Shekoufeh Nikfar
Journal:  Iran J Pharm Res       Date:  2021       Impact factor: 1.696

Review 8.  Concepts of advanced therapeutic delivery systems for the management of remodeling and inflammation in airway diseases.

Authors:  Daljeet Singh Dhanjal; Parvarish Sharma; Meenu Mehta; Murtaza M Tambuwala; Parteek Prasher; Keshav R Paudel; Gang Liu; Shakti D Shukla; Philip M Hansbro; Dinesh Kumar Chellappan; Kamal Dua; Saurabh Satija
Journal:  Future Med Chem       Date:  2022-01-12       Impact factor: 3.808

9.  Cytochrome P450-derived epoxyeicosatrienoic acids and coronary artery disease in humans: a targeted metabolomics study.

Authors:  Akinyemi Oni-Orisan; Matthew L Edin; John Andrew Lee; Michael A Wells; Erin S Christensen; Kimberly C Vendrov; Fred B Lih; Kenneth B Tomer; Xue Bai; Joan M Taylor; George A Stouffer; Darryl C Zeldin; Craig R Lee
Journal:  J Lipid Res       Date:  2015-11-10       Impact factor: 5.922
  9 in total

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