Pharmacodynamics as a tool to improve the antiinfective therapy: from in vitro models to (some) large-scale clinical applications

"Séminaire de l'Ecole de Pharmacie", 
Université catholique de Louvain, 
Brussels, Belgium (13-03-01)

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Table of Contents

Pharmacodynamics as a tool to improve the antiinfective therapy: from in vitro models to (some) large-scale clinical applications

Pharmacodynamics as a tool to improve the antiinfective therapy: from in vitro models fo (some) large-scale clinical applications

What is research all about ?

Antibiotische behandelingen: Wat verlangt de clinicus ?

Farmacokinetiek

Microbiology

Farmacodynamie

What did the textbooks say about antibiotic dosages and schedules in the 70’s ?

What are we going to discuss ?

Aminoglycosides in the 70’s ...

Aminoglycosides monitoring in the 70’s ...

Aminoglycosides toxicity in the 70’s - 80’s ...

Aminoglycoside toxicity is not linked to peak ...

What is the (likely) mechanism of aminoglycoside nephrotoxicity ?...

Aminoglycoside entry in proximal tubular cells is via brush border binding *...

Aminoglycoside accumulation is kidney is saturable at clinically meaningful concentrations * ...

The once-a-day schedule gives less drug accumulation and less renal alterations in rats * ...

Shall you now go to humans ?

Aminoglycoside once-a-day: the philosophy of the first St Luc clinical trials (1985-1989) ...

Using surrogate markers ….

Phospholipiduria can be a surrogate marker of aminoglycoside-induced renal alterations

High tone audiometry can be a surogate marker of a clinically meaningful ototoxicity

Setting up the analysis scheme

Pharmacokinetic results (day 7)...

Phospholipiduria (1)

Phospholipiduria (2)

Phospholipiduria: statistical comment ...

Auditory alterations

Auditory alterations: statistical comment ...

Auditory alterations

General conclusions of the first clinical trials … *

But, will once-a-day be effective ?

Aminoglycosidepeak /MIC ratio is predictive of clinical efficacy

How are you going to show that patients will benefit of receiving aminoglycosides once-a-day ?

The worldwide progress of the once-a-day made by clinicians ...

The fluoroquinolones in 5 ? slides...

The fluoroquinolone problem...

PK/PD and antibiotic efflux pumps… an example with RND...

Is pharmacodynamic important for fluoroquinolones ?

Act directly with the regulators ….

And look at the FDA registration dossier * of a new fluoroquinolone...

But do not forget Belgium ...

Now, the ?-lactams

PK / PD in actie … continu infuus of ?-lactams met 4 g /dag ...

Continu infuus van ? - lactamen in de praktijk: farmaceutische aspecten ... 

1ste toepassing : continu-infuus van ? - lactamen in mucoviscidose

2de toepassing: continu-infuus van ? - lactamen in intensieve zorgen

Degradation products of ceftazidime

Degradation pathways of ceftazidime

Cefatzidime compatibility (clinical conditions)

Now, where to run that study ...

Patients’enrollement: status report February 12th, 2001

PPT Slide

Pharmacodynamics...

Thanking people … *

Aminoglycosides...

Aminoglycosides... The once-a-day story...

The ?-lactams, the fluoroquinolones, etc...

But don’t forget ISAP...

And thanks to the Pharmacy and the * Pharmacists...

Author: Paul M. Tulkens 

Email: tulkens@facm.ucl.ac.be

Home Page: http://www.md.ucl.ac.be/facm/facm-conferences.htm