Immunosuppressants and Antibiotics Bayesian dose adjustment

Pharmacokinetics Newsletter

LIMOGES, Thursday 20^th December 2018 

Web Portal  

Seasons Greetings

The TDM team

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Immunosuppressants and Antibiotics Bayesian dose adjustment

The Pharmacokinetics Newsletter

LIMOGES, Monday 17^th September 2018

Web Portal

Hello,

So that more patients can benefit from our teleexpertise for IS dose adjustment and also in order to update ISBA so that it complies with the regulatory requirements, the ISBA web site will be replaced in 2019, first of all in Europe and then in the rest of the world, by a new system, Expert’IS, developed by the company Optim’Care which is a spin- off of our laboratory.

Expert’IS will of course integrate all the models available on the ISBA system and as it is a medical device, will obtain the CE marking (or equivalent outside Europe) before it is put on the market.

Together with Optim’Care, we will contact you individually to prepare the transfer to this new system.

Thank you for your trust,

The TDM team

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Adaptation Bayésienne des ImmunoSuppresseurs, Antibiotiques et Anti-cancéreux

La NEWSLETTER Pharmacocinétique

LIMOGES, le lundi 17 Septembre 2018 

Portail WEB

Bonjour,

Afin de faire bénéficier à un plus grand nombre de patients de notre solution de téléexpertise pour l’adaptation de posologie des IS mais aussi afin de faire évoluer la solution ABIS pour répondre aux exigences réglementaires, le site web ABIS sera remplacé en 2019 dans un premier temps en Europe et d’autres pays par une nouvelle solution, Expert’IS, développée par la société Optim’Care, spin off de notre laboratoire.

Expert’IS intégrera bien entendu l’ensemble des modèles disponibles sur ABIS et en tant que dispositif médical devra obtenir le marquage CE (ou équivalent hors Europe) avant sa mise sur le marché.

La société Optim’Care et nous-même vous contacterons individuellement pour préparer le passage à la nouvelle solution.

Merci beaucoup pour votre confiance !

L’équipe STP

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Adaptation Bayésienne des ImmunoSuppresseurs, Antibiotiques et Anti-cancéreux

La NEWSLETTER Pharmacocinétique

LIMOGES, le jeudi 5 Octobre 2017 

Portail WEB

Le site ABIS fête sa 100.000^ème demande !

Chers utilisateurs du site ABIS, nous venons de valider la 100.000^ème demande d’adaptation d’immunosuppresseurs, depuis avril 2005. Prochain objectif la 200.000^ème !

Merci beaucoup pour votre confiance!

L’équipe STP

Ce mail n'est pas un Spam, vous recevez cette lettre car vous avez demandé à recevoir des informations du laboratoire de Pharmaco-Toxicologie du CHU de Limoges.
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Immunosuppressants and Antibiotics Bayesian dose adjustment

The Pharmacokinetics Newsletter

LIMOGES, Thursday 5^th October 2017 

WEB Portal

The ISBA website celebrates its 100,000^th request!

Dear ISBA users, we just validated the 100,000^th request for immunosuppressant dose individualization, since April 2005. On the road to the 200,000^th!

Thank you so much for your trust!

The TDM Team

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Immunosuppressants and Antibiotics Bayesian dose adjustment

The Pharmacokinetics Newsletter

LIMOGES, Friday 12^th May 2017 

WEB Portal

Hello !

We are pleased to announce the publication of a new article about population pharmacokinetic modeling and Bayesian estimation, which this time is about ENVARSUS^®  (Once-daily Tacrolimus) in renal and hepatic transplantation:

The ISBA platform is thriving and the number of registered transplantation centers is steadily increasing, while the platform’s activity has remained constant during the past year.

We are taking this opportunity to provide you with a quick overview of the website activity:

-       9836 immunosuppressant kinetics have been modeled so far this year, coming from 50 different hospital centers!

-       Among them, the three most active are:

Mycophenolic acid remains the most modeled immunosuppressant with about three quarters of the total number of requests:

The requests mainly come from metropolitan France and its overseas territories. About 10% of the requests are made by other countries, notably North Africa and the United States of America, or neighbouring countries such as Belgium and Switzerland!

The ergonomics of the web portal has been improved, and an ISBA mobile application will be launched in the near future. The interface will also be improved and a question-and-answer forum will be set up.

Thank you for your trust !

The TDM Team

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Immunosuppressants and Antibiotics Bayesian dose adjustment

The Pharmacokinetics Newsletter

LIMOGES, Tuesday 27^th December 2016 

WEB Portal

 ¤ The ISBA website has expanded this year :

-          Population pharmacokinetic models and Bayesian estimators have been developed for tacrolimus (Envarsus® formulation) in kidney and liver transplantation (optimal sampling times 0, 8 and 12h).

-          Population pharmacokinetic models and Bayesian estimators have been developed for tacrolimus (Advagraf® formulation) in liver transplantation (optimal sampling times 0, 2 and 6h).

¤ Among our New Year resolutions, we are planning to offer you :

-          A new and more ergonomic homepage, adapted for a variety of  screens (tablet, fixed navigator, …)

-          A question and answer forum for problems when entering data on ISBA ( coming summer 2017)

-          The development of PKJust (dose adjustment of antibiotics), taking into account biological and bacteriological information so as to personalize the therapeutic target.

Thank you for your trust !

The TDM Team

 Seasons Greetings to you all

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Immunosuppressants Bayesian Dose Adjustment

The I.S.B.A NEWSLETTER

Tuesday 28th June 2016

ISBA

New Bayesian estimators

We are pleased to inform you that new Bayesian estimators dedicated to the tacrolimus formulation Envarsus® in adult kidney and liver transplantation are now available on our ISBA website.

Envarsus® is a once-daily prolonged release formulation of tacrolimus. It is characterized by increased intestinal bioavailability owing to the Meltdose® technology. This leads to the administration of smaller doses (about 30% less) in comparison to other tacrolimus formulations. Since October 2014, Envarsus® has been approved in Europe for the prevention of rejection in kidney or liver transplantation or the treatment of rejection resistant to other immunosuppressants in adult transplant patients.

Veloxis and Chiesi provided us with the pharmacokinetic data of phase 2 clinical trials in renal and hepatic transplantation to allow us to develop population pharmacokinetic models and Bayesian estimators and we express our gratitude to them.

This tacrolimus formulation is characterized by a different pharmacokinetic profile as compared to Advagraf® with, in particular, lower maximal concentration (the figure below gives examples of modeled PK profiles in renal transplantation).

The slow and prolonged release of Envarsus® leads to a different limited sampling strategy for accurate Bayesian estimation of the AUC0-24h: 0, 8, 12h after dose intake for both types of transplantation.

Of note, it is the best limited sampling strategy leading to the lowest bias between predicted and observed AUC_0-24h. However, AUC_0-24h can be estimated from samples taken at (slightly) different times on condition that the exact times are known.

In conclusion, these new tools are available for adult renal and hepatic transplantation whatever the period post transplantation and the associated immunosupressants.

¤ Examples of PK profiles observed and modeled

Figure 1-Examples of PK profiles modeled using 3 samples (0, 8, 12h) (in black) and observed (in blue) in adult renal transplant patients in a validation dataset (data splitting).

Thank you for your trust!

The TDM Team

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Immunosuppressants Bayesian Dose Adjustment

THE I.S.B.A. NEWSLETTER

LIMOGES, Monday May 4, 2015 

ISBA

The ISBA website is 10 years old!

The ISBA website was launched in April 2005 and celebrated its 10^th anniversary last month.

This would not have been possible without you, our "customers", who have trusted us since the beginning.

¤ 121 transplantation facilities:

No less than 121 different clinical departments, mostly involved in solid organ transplantation, have sent us at least one dose adlustment request. They are located on 6 continents or sub-continents.

¤ An average of 800 requests per month posted on ISBA:

¤ 197 different Bayesian estimators...

In line with our understanding of precision medicine, the ISBA website propose dose adjustment tools adapted to your patient profile, based on a panel of 197 different Bayesian estimators, for the different immunosuppressants, transplanted organ or other conditions, drug associations, etc.

¤ ... for a large panel of organ transplant conditions and auto-immune diseases:

80% of the requests concerned MMF in adult kidney transplant recipients and, at the other end of the spectrum, 5% concerned auto-immune diseases.

¤ Finally and most importantly for patient care, results have all been validated by trained pharmacologists and made available after a median time [25-75^th percentiles] of 56 minutes!

Thank you for your trust!

The TDM Team

This message is not a spam but has been sent to you because you have requested information from the Pharmacology and Toxicology Laboratory at the Limoges University Hospital.
If you wish to be withdrawn from this mailing list, please send a message to the following email address: stp@chu-limoges.fr