Literature DB >> 29193042

Driving Access to Medicines With a Totality of Evidence Mindset: An Opportunity for Clinical Pharmacology.

Karthik Venkatakrishnan1, Jack Cook2.   

Abstract

Access to Medicine (AtM) initiatives have traditionally focused on enabling continuous availability and affordability of medicines for patients in the developing world. A more holistic view of AtM across the discovery-development-regulation-utilization continuum would also include participation in the development and timely access to emerging therapies in diverse populations in the era of precision therapeutics, built upon foundational clinical pharmacology principles, leveraging a Totality of Evidence (ToE) mindset.
© 2017 American Society for Clinical Pharmacology and Therapeutics.

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Mesh:

Year:  2017        PMID: 29193042     DOI: 10.1002/cpt.926

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


  8 in total

1.  Designing phase I oncology dose escalation using dose-exposure-toxicity models as a complementary approach to model-based dose-toxicity models.

Authors:  Kristyn Pantoja; Shankar Lanke; Alain Munafo; Anja Victor; Christina Habermehl; Armin Schueler; Karthik Venkatakrishnan; Pascal Girard; Kosalaram Goteti
Journal:  CPT Pharmacometrics Syst Pharmacol       Date:  2022-08-05

2.  How resilient were we in 2021? Results of a LinkedIn Survey including biomedical and pharmaceutical professionals using the Benatti Resiliency Model.

Authors:  Songmao Zheng; Karthik Venkatakrishnan; Beth Benatti Kennedy
Journal:  Clin Transl Sci       Date:  2022-08-18       Impact factor: 4.438

3.  Application of Machine Learning in Translational Medicine: Current Status and Future Opportunities.

Authors:  Nadia Terranova; Karthik Venkatakrishnan; Lisa J Benincosa
Journal:  AAPS J       Date:  2021-05-18       Impact factor: 4.009

Review 4.  Model-informed assessment of ethnic sensitivity and dosage justification for Asian populations in the global clinical development and use of cladribine tablets.

Authors:  Alain Munafo; Nadia Terranova; Dandan Li; Ping Liu; Karthik Venkatakrishnan
Journal:  Clin Transl Sci       Date:  2021-10-26       Impact factor: 4.689

5.  Pharmacometric modeling and machine learning analyses of prognostic and predictive factors in the JAVELIN Gastric 100 phase III trial of avelumab.

Authors:  Nadia Terranova; Jonathan French; Haiqing Dai; Matthew Wiens; Akash Khandelwal; Ana Ruiz-Garcia; Juliane Manitz; Anja von Heydebreck; Mary Ruisi; Kevin Chin; Pascal Girard; Karthik Venkatakrishnan
Journal:  CPT Pharmacometrics Syst Pharmacol       Date:  2022-01-19

6.  Model-informed approach for risk management of bleeding toxicities for bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1.

Authors:  Yulia Vugmeyster; Ana-Marija Grisic; Justin J Wilkins; Anja H Loos; Roland Hallwachs; Motonobu Osada; Karthik Venkatakrishnan; Akash Khandelwal
Journal:  Cancer Chemother Pharmacol       Date:  2022-09-06       Impact factor: 3.288

7.  Diversity and Inclusion in Drug Development: Rethinking Intrinsic and Extrinsic Factors with Patient Centricity.

Authors:  Karthik Venkatakrishnan; Lisa J Benincosa
Journal:  Clin Pharmacol Ther       Date:  2021-09-22       Impact factor: 6.903

8.  Pharmacometrics meets statistics-A synergy for modern drug development.

Authors:  Yevgen Ryeznik; Oleksandr Sverdlov; Elin M Svensson; Grace Montepiedra; Andrew C Hooker; Weng Kee Wong
Journal:  CPT Pharmacometrics Syst Pharmacol       Date:  2021-08-19
  8 in total

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