Re: [NMusers] Observed (yaxis) vs Predicted (xaxis) Diagnostic Plot - Scientific basis.

2023-08-24 Thread Alan Maloney
that the y-axis ran from +20 to -20!). Best wishes, Al Alan Maloney PhD Consultant Pharmacometrician Free Book! - Drug Development For Patients - see www.alanmaloney.com <http://www.alanmaloney.com/> - please read, send comments and support patients! Phone: +46 734 04 38 49 E-mail:al_i

[NMusers] FDA Exposure-Response Guidance - can pharmacometricians work towards a common position?

2018-05-07 Thread Alan Maloney
and I will send you the files. https://www.dropbox.com/sh/73c02p74506inu8/AAChUaPmFg_QNYp72gEPalm1a?dl=0 p.s. Thank you GloboMax/ICON for allowing me to use your mailing list to engage other pharmacometricians Alan Maloney PhD Consultant Pharmacometrician Phone: +46 35 10 39 78 E-mail:al_i

[NMusers] D-E-R at the centre of drug development and regulatory approval - a viewpoint

2015-03-27 Thread Alan Maloney
Dear All, I have been meaning to send this out for a while now, and Nele's mail about MCP-MOD was a good trigger (since I believe D-E-R should extend far beyond being a Phase 2 activity). I am keen to see drug development, and the regulatory requirements for approval, change. This short

Re: [NMusers] Using MCP-MOD in dose finding for Phase 3

2015-03-27 Thread Alan Maloney
Hi Nele/All, I wanted to (belatedly) add a few comments about MCP-MOD and the comments you have received, and Phase 2 design/analysis in general. In short, I agree with most of the observations made by yourself and others, and I would not want to use MCP-MOD (see my comments