S. Cole

发表

European regulatory perspective on pediatric physiologically based pharmacokinetic models

S. Cole, J. Hay, E. Luzón, 2017 .

Quantifying Uncertainty in Predictions of Hepatic Clearance

Paul W. Bernhardt, J. Rogers, S. Cole, 2011 .

Lipophilicity and other parameters affecting brain penetration

Susan Cole, H. Waterbeemd, F Atkinson, 2002 .

Developing Clinically Relevant Dissolution Specifications (CRDSs) for Oral Drug Products: Virtual Webinar Series

Andreas M. Abend, B. Griffin, Diansong Zhou, 2022, Pharmaceutics.

Pharmacokinetic data in pregnancy: A review of available literature data and important considerations in collecting clinical data

S. Cole, Janet Nooney, P. Coppola, 2022, Frontiers in Medicine.

EMA Review of Daunorubicin and Cytarabine Encapsulated in Liposomes (Vyxeos, CPX-351) for the Treatment of Adults with Newly Diagnosed, Therapy-Related Acute Myeloid Leukemia or Acute Myeloid Leukemia with Myelodysplasia-Related Changes.

R. Hemmings, F. Pignatti, Y. Barbáchano, 2020, The oncologist.

A novel series of potent and selective PDE5 inhibitors with potential for high and dose-independent oral bioavailability.

K. Beaumont, N. Mount, David G. Brown, 2006, Journal of medicinal chemistry.

The discovery of UK-369003, a novel PDE5 inhibitor with the potential for oral bioavailability and dose-proportional pharmacokinetics.

M. Bunnage, K. Beaumont, D. Leahy, 2012, Bioorganic & medicinal chemistry.

The Use of Pregnancy Physiologically Based Pharmacokinetic Modeling for Renally Cleared Drugs

S. Cole, P. Coppola, Essam Kerwash, 2022, Journal of clinical pharmacology.

Discovery of a selective small-molecule melanocortin-4 receptor agonist with efficacy in a pilot study of sexual dysfunction in humans.

Steven W. Martin, A. Brown, D. Fradet, 2010, Journal of medicinal chemistry.

A summary of the current drug interaction guidance from the European Medicines Agency and considerations of future updates.

Essam Kerwash, Susan Cole, Anita Andersson, 2020, Drug metabolism and pharmacokinetics.

The Discovery of a Potent, Selective, and Peripherally Restricted Pan-Trk Inhibitor (PF-06273340) for the Treatment of Pain.

Kiyoyuki Omoto, Angus Nedderman, Sharan K Bagal, 2016, Journal of medicinal chemistry.

Predicting Penetration Across the Blood-Brain Barrier from Simple Descriptors and Fragmentation Schemes

Mark L. Lewis, Adam Ibrahim, Michael H. Abraham, 2007, J. Chem. Inf. Model..

Chapter 2:ADMET for the Medicinal Chemist

K. Beaumont, J. Gosset, S. Cole, 2010 .

Advanced Methods for Dose and Regimen Finding During Drug Development: Summary of the EMA/EFPIA Workshop on Dose Finding (London 4–5 December 2014)

N Holford, AC Hooker, K Ogungbenro, 2017, CPT: pharmacometrics & systems pharmacology.

Physiologically Based Pharmacokinetics Model in Pregnancy: A Regulatory Perspective on Model Evaluation

S. Cole, P. Coppola, Essam Kerwash, 2021, Frontiers in Pediatrics.

Physiologically Based Models in Regulatory Submissions: Output From the ABPI/MHRA Forum on Physiologically Based Modeling and Simulation

A Nordmark, G. Scott, F. Bouzom, 2015, CPT: pharmacometrics & systems pharmacology.

Full efficacy with no CNS side-effects: unachievable panacea or reality? DMPK considerations in design of drugs with limited brain penetration

Tanya L Hay, M. Varma, A. El‐Kattan, 2012, Xenobiotica; the fate of foreign compounds in biological systems.

Physiologically based pharmacokinetic modeling in regulatory decision‐making at the European Medicines Agency

E Luzon, K Blake, S Cole, 2017, Clinical pharmacology and therapeutics.

Commentary on the MID3 Good Practices Paper

Aris Dokoumetzidis, Norbert Benda, Wei Zhao, 2017, CPT: pharmacometrics & systems pharmacology.

A review of clinical pharmacology deficiencies of European centralised drug marketing authorisation applications.

S. Cole, J. Hay, Alexandra-Roxana Ilie, 2020, Regulatory toxicology and pharmacology : RTP.

The Importance of the Human Mass Balance Study in Regulatory Submissions

S. Cole, P. Coppola, Anita Andersson, 2019, CPT: pharmacometrics & systems pharmacology.

Use of Physiologically Based Pharmacokinetic Modeling for Hepatically Cleared Drugs in Pregnancy: Regulatory Perspective

S. Cole, P. Coppola, Essam Kerwash, 2023, Journal of clinical pharmacology.

Pharmacokinetic Characterization to Enable Medicine Use in Pregnancy, the Potential Role of Physiologically‐Based Pharmacokinetic Modeling: A Regulatory Perspective

S. Cole, Janet Nooney, S. Lam, 2020, CPT: pharmacometrics & systems pharmacology.

Discovery of a selective small-molecule melanocortin-4 receptor agonist with efficacy in a pilot study of sexual dysfunction in humans.

D. Fradet, M. Lansdell, D. Hepworth, 2010, Journal of medicinal chemistry.