PKPD - Pharmacokinetic/Pharmacodynamic - Mango Solutions

PK/PD

“Pharmacokinetics may be simply defined as what the body does to the drug, as opposed to pharmacodynamics which may be defined as what the drug does to the body”

 

Benet LZ (1984). “Pharmacokinetics: Basic Principles and Its Use as a Tool in Drug Metabolism”

A vital aspect of drug development is the understanding of drug kinetics and the impact of those compounds on a living organism.  This area of study, known formally as “pharmacokinetics” (or “PK”), typically uses mathematical models to describe key aspects of a drug’s elimination from the body.

Conversely, pharmacodynamics (or “PD”) is the study of how an amount of compound at the target site produces effects (such as heart rate, blood pressure or an improvement in a target disease).  Together, these fields constitute the area of “Pharmacokinetics Pharmacodymanics” or simply “PKPD”, which can facilitate an understanding of the effect of a compound on a living organism over time, aiding in the design of safe dosing strategies.

PKPD - Effect vs. Time

Mango have a great deal of experience providing services and products to PKPD modellers and to their internal customers.

Read our ‘R Solutions for the Pharmaceutical Industry’ Overview

 

Some of the most common services performed for many of the foremost PKPD groups in the world include:

 

Targeted R Training

Mango are the premier providers of R training in the world today, teaching over 600 people a year on the use of R. These courses are taught to users in a variety of sectors; however, Mango’s key strength is in the field of clinical pharmacology and PK modelling, where their “R for Pharmacometrics” course is particularly popular.  Mango’s approach to training is to leverage their  many years’ experience  to create courses that are tailored to each group’s needs. Such training schedules are usually customised to meet a customer’s needs, however a typical 3 day “R for Pharmacometrics” course might contain the following topics:

Day 1

Day 2

Day 3

Introduction to R

Writing Functions

Lattice Graphics

The R Environment

Functions for Data Structures

Fitting R Models

R Data Objects

Apply Functions

Working with NONMEM

R Functions

Traditional R Graphics

Simulation

Click here to find out more about our R courses.

R Consulting Services

Mango’s team consists of consultants with a mixture of R, IT and pharmacometric skills.

This is a highly sought-after skillset and, as such, our consultants are in high demand to perform a variety of consulting tasks.

This includes the following:

  • Creating R code for a customer in order to perform a specific activity
  • Validating customer R code
  • Analysing customer data
  • Performing general R programming tasks
  • Advising on R/IT related topics

Contact us to find out how Mango can help your business

IT Environments

An effective pharmacometrics team needs a modern modelling environment within which to perform its activities in an efficient, centralised and compliant manner. This involves the installation and validation of a number of modelling tools (such as NONMEM, R and PsN) within an environment that is scalable and performance focused and cab provide the rigour required by regulatory bodies. This typically includes the use of modern, high performance computing systems (such as grids or cloud-based infrastructures) along with the provisioning of version control and audit records.

Mango’s unique mixture of modelling and IT knowledge makes us an ideal partner to design, implement and support a platform serving a modelling team’s activities. We have worked with modelling groups large and small to design effective platforms that balance usability, rigour and budget. For projects such as these, Mango work very closely with internal business, IT and compliance teams to ensure the platform delivered fully meets each group’s requirements.

Contact us to find out how Mango can help your business

Application Development

In addition to our consulting team, Mango have a large team of mainstream software developers, testers and project managers.

This allows Mango to create targeted applications for clinical pharmacology and modelling groups to:

  • Automate processes that can take some time in order to improve efficiency
  • Add rigour to existing processes so as to comply with regulatory requirements
  • Distribute capabilities to a wider group to allow internal customers to self-serve
  • Visualise data and results in a manner that allows effective decisions to be made
  • Centralise key knowledge so that it can be managed and applied against future work
  • Accelerate computing processes in order to produce results more quickly

Contact us to find out how Mango can help your business

Products

Mango have developed a number of products aimed at clinical pharmacology / modelling groups. These can be used either as off the shelf products or technologies that can be highly customized in order to more closely meet customer requirements.

The provision of Mango projects will often include additional services such as customization, training, and ongoing support and maintenance.

Contact us to find out how our products can help your business.

Validation and Support

As the premier providers of R to pharmacometric groups, Mango have been frequently asked to support the validation and verification of the (open source) R language. This has resulted in a suite of documents and test scripts known as the “ValidR” toolkit, which is often used as the basis of R validation for modelling teams. This enables rapid Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) of R using typical PK packages such as the Xpose suite of libraries from Uppsala, Mango’s libraries (RNMImport, RNMGraphics, MSToolkit) and others.

This engagement is typically coupled with an ongoing support and maintenance contract. The exact details of this can vary to meet with specific customer requirements but could include aspects such as:

  • Frequent updates to R and packages (e.g. 1 per year)
  • Email support to help with R queries
  • Call of consulting time
  • Training on R (onsite or series of regular webinars)

Validation Services

Mango Solutions’ dedicated test and validation teams ensure GxP requirements are met via our computerised system validation services.  Mango Solutions have been providing validated software solutions to the Pharmaceutical industry for over a decade.

Click here to find out more about Validation Services.

 

Contact us to find out how Mango can help your business

Read our ‘R Solutions for the Pharmaceutical Industry’ Overview