The IQnca R package
1
Introduction
1.1
What?
1.2
Why?
1.3
Validation
1.4
Documentation
1.5
Getting Help
1.6
Future IQnca Developments
2
Installation
2.1
Easy Installation
2.2
License
2.3
Source Code
3
Workflow
3.1
Import Data
3.2
Implement Analysis Plan
3.2.1
Ignored observations
3.2.2
Customized AUC intervals
3.2.3
IQRdataNCA
export
3.3
Explore and Clean Data
3.4
Present Analysis Data
3.5
Execute the NCA
3.6
Present NCA Results
3.6.1
Non calculated and unreliably calculated PK parameters
3.7
Statistical Analysis
3.8
Reporting
4
Examples
4.1
Example 1: Bolus single dose data
4.1.1
Data preparation
4.1.2
Apply analysis settings
4.1.3
NCA parameter calculation
4.2
Example 2: Infusion single dose data
4.2.1
Data preparation
4.2.2
BLQ data handling
4.2.3
Data listings and tables
4.2.4
Data plots
4.2.5
NCA parameter calculation
4.2.6
Result listings and tables
4.2.7
Reporting
4.3
Example 3: Extravascular first dose and steady state
4.3.1
Data exploration
4.3.2
NCA parameter calculation
4.3.3
Reporting
4.4
Example 4: Single oral dose data
4.4.1
NCA parameter calculation
4.4.2
Comparison of results
4.5
Example 5: Special pre-dose handling
4.5.1
Duplicating the pre-dose records
5
Data Specification
5.1
IQdataNCA Function
5.2
IQdataNCA Object
6
Method Documentation
6.1
Grouping and profile differentiation
6.2
NCA models
6.3
Pre-dose data handling
6.4
BLQ data handling
6.4.1
For Listings
6.4.2
For Summary Tables and NCA
6.4.3
For Individual and Summary Plots
6.5
Terminal slope calculation
6.5.1
Automatic terminal slope selection
6.6
AUC calculation methods
6.6.1
AUC interval calculus
6.6.2
Concentration interpolation/extrapolation
6.7
Overview of NCA parameters
6.7.1
Last observation defintion
6.7.2
For all profile types
6.7.3
Only for single and first dose profiles
6.7.4
Only for steady-state profiles
6.7.5
Formulas
7
Support
Appendix
A
Function Reference
A.1
General Data I/O
A.2
Help & Documentation
A.3
Installation
A.4
NCA Data
A.5
NCA Data Figures
A.6
NCA Data Listings
A.7
NCA Data Tables
A.8
NCA Parameter Export
A.9
NCA Parameter Listings
A.10
NCA Parameter Tables
A.11
NCA Report
A.12
NCA Slope
A.13
Output & Compliance
B
Release Notes
V1.0.1 September 22, 2021
V1.0.0 February 12, 2021
(c) 2021 IntiQuan GmbH
B
Release Notes
V1.0.1 September 22, 2021
Added function install_MIDDmodule()
Fixed special characters in the book
Corrected unit for AUCLSTD
Small fixes
V1.0.0 February 12, 2021
First official release
Enjoy!
