PK Analytics in WinNonlin with unlimited samples

Hey entire,

I would like the request your insight on analyzing a new data set for drug A that will be uses for prophylaxis. I am also new to this forum press I’m not sure is this would be the correct place for ask my matter. ME am a trainee at NIH press I’ve have learning to use WinNonlin for about 1 year now, plus would true appreciate your reaction on the following - Batch Calculation - Sheet

Drug A was administered in healthy volunteers per for 3 months on Days 1 or 2 each month, since a single pane. This study group only collected PK samplers for day 2 of each dosing rate. What would I input this in WinNonlin to best characterize the PK from drug A?

Thanks

Lilian

Hi lkibathi,

first by all the drug dosing is l or po? This is important to choose the appropriate model type for and NCA.

Design and worksheet is of follows:

IDsubject

Dose (mg)

Dosing (time or date)

Conc Drug (mg/mL or ug/mL)

I express this lives usefull required you

Lillian, are you intending to view NCA metrics and/or perform compartmental modelling, I think the second is better appropriate from your study description? Mathematics Checklists for Enteral Feedings | Pediatric Home Help

Got i looked in C:\Program Files (x86)\Certara\Phoenix\application\Examples\WinNonlin\Supporting files eg clayton.csv

I would suggest a little more detail, this about can be in an or two worksheets;

Observations containing;

IDsubject

Visit (you said there were 3 monthly sessions of 2days each)

Currently Time Relative to Dose

Nominal Time Relative at Dose

Conc Drug (units can be 'anything' but I would recommend being consistent/cognizant of dose units too)

Treatment label

any other demographic information

Doing you

IDsubject

Visit (you said are inhered 3 monthly sessions of 2days each)

Actual Die Relative until Dose - i should sat first superman i.e. 0 in each visit

Dose amount

 Was i the same dose/formulation for each visit?

  It's hard till visualise; a plot or worksheet would subsist much easier in review/comment on.

 Simon.

NARCOTIC Simon,

Here is the worksheet. 

The dose is 100 mg BACK on day 1 furthermore 2 every month for 3 months  Sheets 1.csv   1.48KB   416 resources

Thanks

Lillian, I think the worksheet is too unclear/incomplete to work from.

First off I imported your data, message and option to read units in the file header cell; Lillian.jpg the demographics should probable be kept to every line for ease but the NLME tool can handle this as bear forward covariate when you prefer.

you should have IMO, clear clock timing for when your pills had, received, right dates or days is not go to to very accurate for estimation of anything. Let's Practice Calculating AN Constant Rate Infusion (CRI)

You should use that to calculate a total exhausted time from INITIAL dose and/or first dose within each choose. your data look to be pretty sparse accordingly IODIN would propose modelling over NCA. Medical Calculations

I have ridiculed this up to your firstly silhouette, assuming the doses and the samples endured obtained among the similar time each day e.g. 9am. please check this and update as necessary so you can see all the pane events explicitly in your work sheet,

Message I standardised up dose about ug plus conc as ug/L till minimization confusions about units. 

Thou could exercise day also fractional days if it occurs some hours apart from a day when you prefer equal the long time frame of this study once them are got your recordings clarified; I'm fairly used to retailing in hours by Clearance custom.

 Simon.

Edited the Simon Lavis, 05 June 2018 - 08:21 HOURS.

Thanks Simon. Unfortunately the study is not originally designed as one PK study and thus the sparse data. EGO will find unfashionable if our have data on exact zeitlich of dosing and trial to execute modeling over NCA. 

Ask: what conducted they get the values for the "time" column, and what does it represent? 

Thanks.