Pharmacokinetic(PK)/Pharmacodynamic (PD) Analysis  


Pharmacokinetics (PK): is what the body does to the drug, it characterizes the time course of concentrations of the drug and/or the drug metabolite after drug administration in order to obtain information on drug disposition in the body.  4 phases of PK process inside the body- ADME: Absorption, Distribution, Metabolism, Excretion.  Pharmacodynamics (PD): is what the drug does to the body, it studies the body’s pharmacological response to a drug (measured in terms of AEs & Efficacy).  PKPD: studies the dose-effect relationship.

PK/PD analysis involves the study of the treatment drug's dose adminstration and absorption levels over times.  Both date/times as well as concentration levels of both treatment and PK drug are collected.  Often pre-dose values are compared with post-dose values.  It may also be important to keep track of differences between planned and actual visit date/times.  To determine optimium treatment dose, comparisons may be made by treatment dose and concentration amount by time since last dose. 

Below is a collection of PK/PD Analysis SAS® papers.  See Proc SQL for complex many-to-many type joins and Statistical Analysis for Geometric Mean and %CV. See also NOTSORTED option to better control sort order.  See SAS Functions for LAG() examples.  See PK/PD Dummies book abstract.  Mind map.

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Introduction to Pharmacokinetics [Presentation]  PK/PD Presentations   FDA Guide

1. Harmonized PK Analysis and Reporting, Ian Berretto

2. SAS APPLICATION FOR PHARMACOKINETIC EVALUATION AND ANALYSIS OF THE EFFECT OF TREATMENT WITH A NEW ANTIDEPRESSANT DRUG IN A POPULATION WITH MAJOR DEPRESSION
Lev Sverdlov, John Noble, Gabriela Nicolau

3. Constructing a Data Warehouse for Pharmacokinetic Data, S.P. Koprowski, J.S. Barrett

4. Smoothing Techniques for Pharmacokinetic and Pharmacodynamic Profiles, Naum M. Khutoryansky

5. Geometric Statistics in PK analysis - Programmer’s perspective, Niraj J. Pandya, Smitha Mullapudi

6. Automate Pharmacodynamic Analyses of Repeated Measures, Adeline Yeo, Grace Li

7. Calculating time-to-event parameters using a single DATA step and a RETAIN statement, Andrew L Hulme

8. Considerations in the Submission of Pharmacokinetics (PK) Data in an SDTMCompliant
Format, Fred Wood, Peter Schaefer, Richard Lewis
 [PC Domain]

9. Streamlining Regulatory Submission with CDISC/ADaM Standards for Non-standard Pharmacokinetic/Pharmacodynamic Analysis Datasets, Xiaopeng Li, Katrina Canonizado, Chun Feng, Nancy Wang [ADPC]

10. A SAS® Macro to address PK timing variables issues, Timothy J Harrington

11. Submission of Pharmacokinetics (PK) Data in a CDISC Compliant Format, Yu Zhu 

12. Equivalence and Noninferiority Testing Using SAS/STAT® Software, John Castelloe, Donna Watts

13. Statistics and Pharmacokinetics in Clinical Pharmacology Studies, Amy Newlands

14. A Peak at PK ± An Introduction to Pharmacokinetics, Hannah Twitchett, Paul Grimsey

15. Introduction to PK/PD data structures and process optimization to get analysis ready data, Smitha Mullapudi

16. Analysis of Pharmacokinetic Data : Using SAS to Create an Autonomous Environment for the Pharmacokineticist, Steve Prust [Presentation]

17. The Creation of ADaM Datasets for Pharmacokinetic (PK) Analysis [Video]

18. Overview of Handling of PK Data in CDISC Standards, Peter Schaefer [Presentation]

19. Scrambled Data – A Population PK/PD Programming Solution Sharmeen Reza

20. Challenges and Strategies in PKPD Programming Jing Su and Jiannan Kang [NONMEM]

21. Data Standards for Population Pharmacokinetic Analysis (POPPK) and Non-Compartmental Analysis (NCA), Neelima Thanneer

22. NONMEM – A Programmer point of view, Raghu Kishor Koukuntla

23. Growing Needs in Drug Industry for NONMEM Programmers Using SAS, Sharmeen Reza


Bioequivalence [Presentation, YouTube, Introduction]

1. A SAS® Tool for the Presentation and Statistical Analysis of Data from Bioavailability
and Bioequivalence Studies, Melvin Munsaka, Carl Haske

2. Noncompartmental Pharmacokinetics and Bioequivalence Analysis, Arturo Soto Matos-Pita, Bernardo de Miguel Lillo [AUC]

3. BeST – Bioequivalence Study Template, Pekka Heikkilä, Tuomas Kemppainen, Tiina Kirsilä, Pasi Korhonen

4. METHODS OF STUDYING BIOAVAILABILITY AND BIOEQUIVALENCE

5. GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE

6. Guidance for Industry Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA

7. how to use inferiority study to prove superiority results Search

8. Through the looking glass: understanding non-inferiority

9. Statistical Assessment of Superiority, Equivalence and Non-Inferiority in Clinical Trials

10. Methodological aspects of non-inferiority and equivalence trials

11. Points to consider on switching between superiority and non-inferiority

12. Non-Inferiority Clinical Trials to Establish Effectiveness [FDA Guide]


CDISC

PC/ADPC - Pharmacokinetic Concentrations Detail dataset

PP/ADPP - Pharmacokinetic Parameters Summary dataset such as AUC and TMAX

1. Considerations in the Submission of Pharmacokinetics (PK) Data in an SDTMCompliant Format, Fred Wood, Peter Schaefer, Richard Lewis

2. Implementation of CDISC ADaM in the Pharmacokinetics department, Joanna Magielse, Tineke Callant, Elke Vansnick

3. Submission of Pharmacokinetics (PK) Data in a CDISC Compliant Format, Yu Zhu

4. Pharmacokinetics Data Submission in the CDISC Environment, Y. Xie, Wang

5. IMPLEMENTATION OF CDISC ADAM IN THE PHARMACOKINETICS DEPARTMENT

 

 

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