Whether to deliver medication via oral, infusion, injection, patch, or one of the multiple other methods can make a huge difference to the outcome of a clinical study and the viability of new medicine.
Administration of any medication requires a thorough understanding of the drug, including how it moves through the body, when it needs to be administered, any possible side effects or reactions, and indeed the correct way to deliver it. Especially considering that the extent and time course of drug levels, and therefore the drug action itself can be markedly affected by the route of drug administration into the subject, as well as the pattern of drug distribution within the subject.
As an example, drugs that are rapidly cleared by hepatic processes will show a decreased extent of availability following oral administration due to the metabolism of the drug on its first pass through the liver. The magnitude of this first-pass effect will depend on the blood flow to the liver and its intrinsic clearing ability, i.e. the ability of the organ to eliminate the drug independent of the rate at which the drug is brought to it.
With this in mind, it is paramount to perform the correct series of tests in the clinical and pre-clinical stages of drug development to get it right.
Understanding that drug distribution within the subject will also depend on the blood flow to various sites in the body as well as the partition coefficient of the drug between the blood and the distributive organs and that the protein binding both in the plasma and in the tissues will further affect this distribution, it’s easy to see why science and experience play a huge part in setting out the testing criteria.
Specialist pharma services companies such as QUINTA-ANALYTICA have over 20-years of experience, and dozens of world-class scientists in-house who have conducted a prolific amount of trials with different administration techniques between groups in order to achieve the right outcome for their clients.
In addition to dosing standard oral formulations, they have experience with orodispersible films, parenteral intravenous and other formulations, patches, and even creams, giving them the ability to offer a huge array of variable testing and making them a perfect partner in your clinical testing arsenal.
Get in touch with us to learn more.