Tenth Workshop 2001 on Adaptive Control of Drug Therapy

Organized by

ADCAPT, and the USC Laboratory of Applied Pharmacokinetics

Individualizing Drug Therapy in 2001

Necessities, Difficulties, and Opportunities

Lyon, France, 27-29 June, 2001

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Vers. 23/05/01

This workshop in applied pharmacokinetics is organized by ADCAPT (Hospices Civils de Lyon) and the Laboratory of Applied Pharmacokinetics of the University of Southern California School of Medicine. It is designed for clinicians, practitioners, and those in the industry who are interested in the need to manage, control, and minimize the variability of various potentially toxic drugs and medications. This work utilizes the work, concepts, and both the clinical and research software developed jointly by ADCAPT since 1986 and by USC since 1967.

Sponsored by

Rationale for this workshop

While techniques of modeling drug behavior using population pharmacokinetic/dynamic models have evolved considerably during the past 30 years, their clinical applications have not kept pace. The initial interest in reducing toxicity, for example, with antibiotics, has diminished, and the use of these techniques in new areas has not been optimized (for example, in AIDS and cancer chemotherapy, antihemophilic therapy, reduction of the secondary effects of anticoagulants and psychotropic drugs, and in transplant management). Similarly, the legal descriptions of medications already commercialized has grown, notably concerning populations at risk, in whom the variability has become better known, but the by now well-established techniques for managing such risks optimally with digoxin, lidocaine, aminoglycosides, and, more recently, busulfan, have not always been recommended and employed in new situations. This workshop seeks to remedy this problem.

Objectives

  1. To investigate the possibilities and the conditions between the needs for such dosage individualization and the benefits to accrue from it.
  2. To optimize the utilization of the capabilities of the Clinical Win USC * Pack programs to permit optimal planning, monitoring, and adjustment of drug dosage regimens under the practical constraints of daily use.

Organization

An initial day of conferences and discussions, on Wednesday June 27, followed, for those who wish it, by a second day of practical applications, done in small group discussions in a clinical setting. Thursday June 28 will be primarily for those participants from outside Lyon, while Friday June 29 will be primarily for those from the area of Lyon and its environs.

It is preferable, but not indispensable, that the participants have some prior experience in the use of software for dosage adaptation and adjustment, and for population PK/PD modeling.

The official languages will be French and English. Simultaneous translation will not be provided, but may be possible to facilitate small group discussions as needed.

Number of participants

The number of participants is limited to 100 on the first day, and to 20 on the second and third days. Because of this, registrations will be given in the order received.

Where and when?

The first day of conferences and discussions will take place in the Grand Réfectoire des Sœurs de l'Hôtel Dieu (Hospices Civils de Lyon).

The second and third days of practical and directed will be held at the Pharmacy Service, Hospital Antoine Charial (Hospices Civils de Lyon).

L'Hôtel Dieu and the Hospital Antoine Charial are easily reached: The Hôtel Dieu is in central Lyon. The Hospital Antoine Charial is reached from the center of Lyon by the metro, line D, direction Gare de Vaise, station Gorge de Loup) then by bus (n°74, station Maison de Santé / Hospital A. Charial).

Lyon, noted for its historic center (inscribed in the World Inheritance of UNESCO), is an ideal place for convivial gatherings of this type. It is easily reached by plane (Aéroport International Saint Exupéry), by train (TGV) and by various highways (A6, A7, A42,…).

Fees

A fee of 100 Euros (655 FF) for the first day (Tuesday June 26 only), 200 Euros (1310 FF) for the two days (Wednesday the 27th and Thursday the 28th and for those outside the Lyon area or Wednesday the 27th and Friday the 29th for those from Lyon). This includes the proceedings and work notes, and for the second day (the 28th or 29th) the noon lunch at Hospital A. Charial; it does not include the lunch on Wednesday the 29th, as many restaurants are available nearby. It also does not include any hotel expenses.

A convivial get-together will be planned at the Hôtel Dieu if enough registrants indicate that they would like it.

Lodging

Lodging is not included in the registration fee. Registrants will receive a list of hotels nearby, and a map.

Faculty

These members of ADCAPT have been involved in numerous national and international publications (1) on the adaptation of drug dosage regimens in daily clinical practice, (2) in population pharmacokinetic modeling, and (3) in pharmacodynamic modeling, especially with antibiotics.

Organizational Committee

Gilles Aulagner, Xavier Barbaut, Nathalie Bleyzac, Gérard Carret, Bruno Charpiat, Daniel Claude, Marie-Aude Confesson, Stéphane Corvaisier, Serge Ferry, Roger W. Jelliffe, Stéphane Lecoq, Pascal Maire, Christine Pivot, Jean Sassard.

Workshop Secretariat

Joëlle Baffie, ADCAPT – Pharmacy Service, Hospital A. Charial, 40 avenue de la Table de Pierre, 69340 Francheville, France ; tél : (33) 04 72 32 34 87, fax : (33) 04 72 32 39 08, email : adcapt@cismsun.univ-lyon1.fr

International Secrétariat : Michel Ducher, Hôpital A. Charial, 40 avenue de la Table de Pierre, 69340 Francheville, France ; tél : (33) 04 72 32 34 87, fax : (33) 04 72 32 39 08, email : adminstrateur@mduch.org

With the support of

Xème Atelier ADCAPT/USC : individualizing Drug therapy in 2001

Necessities, Difficulties, and Opportunities

Conferences and discussions

Lyon, France, June, Wednesday 27, 2001

Grand Refectory Room of the Sisters, Hôtel Dieu, Hospices Civils de Lyon,

1, Place de l'Hôpital

69288 Lyon Cédex 02

Program (updated May, 23)

08h45 - 08h50 :

Welcome,

Dr. Pascal Maire, Pr. Roger W. Jelliffe,

I. DESCRIBING AND ESTIMATING VARIABILITY

Chairpersons : Daniel Claude, Bruno Charpiat,

08h50 - 09h00 :

PROBLEM STATMENT : What the physicians can do in clinical practice for dealing with low molecular weight heparin (LMWH) variability ?

Dr. Pascal Maire,

09h00 - 09h40 :

Description of therapeutic variability by population PK/PD modeling in 2001,

Pr. Roger W. Jelliffe,

09h40 - 10h00 :

The Hill's equation revisited, Dr. Michel Maurin,

10h00 - 10h20 : Break

10h20 - 10h40 :

Modeling the oral absorption of drugs - an example with cyclosporine,

Dr. Nils Ove Hoem,

10h40 - 11h00 :

Modeling the differential renal aging process - an example of the Z coefficient

with amikacin, - Dr. Michel Ducher,

11h00 - 11h20 :

Modeling the toxicity of drugs - example with renal toxicity of aminoglycosides,

Dr. Florent Rougier,

11h20 - 11h40 :

Parametric and nonparametric modeling - example of antiepileptic drugs,

Dr. Irina Bondareva,

11h40 - 12h15 :

Discussion of the need to describe and control therapeutic variability in 2001,

All participants,

12h30 - 14h00 : Lunch at your convenience (many good restaurants are near the Hotel Dieu)

II. CONTROLLING VARIABILITY

Chaipersons : Gérard Carret, Nathalie Bleyzac,

14h00 - 14h45 :

Controlling drug therapy with Win USC*Pack 2001,

Pr. Roger W. Jelliffe,

14h45 - 15h00 : Discussion

15h00 - 15h20 :

Patient data file managment : Win PK File manager,

Dr. Xavier Barbaut,

15h20 - 15h40 :

Is the schedule more important than the dose itself ?

Pr. Daniel Claude,

15h40 - 16h00 :

Drug transfer into lung with infusion delivery,

Pr. Jean-Maurice Vergnaud,

16h00 - 16h20 : Pause

16h20 - 16h40 :

Is a concentration controlled trial suitable for a clinical study performed

in infants treated with sulphadoxine / pyriméthamine for congential toxoplasmosis ?

Drs. Bruno Charpiat, et aL

16h40 - 17h00 :

Adaptative control during transpantations : example with busulfan and cyclosporine,

Dr . Nathalie Bleyzac,

17h00 - 17h20 :

Population pharmacocinetic and adaptive control of

factor VIII in hemophilic patients,

Drs. Valérie Chamouard, Marie-Stéphane Essner, et al.

17h20 - 17h40 :

Adaptive control and population pharmacokinetics of low molecular weight heparin (LMWH) using USC*Pack, NPEM and HBPM : WHERE ARE WE?

Dr. Nathalie Choudey,

17h40 - 18h30 (please try to respect the complete daily program) :

Round table and general discussion :

Between forgetfulness and necessity to deal with therapeutic variability in 2001,

All participants.

 

Tenth Workshop 2001 on Adaptive Control of Drug Dosage

Organized by

ADCAPT and the USC Laboratory of Applied Pharmacokinetics

Individualizing Drug Therapy in 2001

Necessities, Difficulties, and Opportunities

Practical Applications (preferential registration for nonLyonnais participants)

Lyon - Francheville, France, Thursday 28 June, 2001

Service Pharmaceutique, Hospital Antoine Charial, Hospices Civils de Lyon,

40, Avenue de la Table de Pierre,

69340 Francheville

09h00 - 09h15 :

Welcome,

Pr. Roger W. Jelliffe, Dr. Pascal Maire, and ADCAPT,

09h15 - 10h30 :

Win USC*Pack and dosage adaptation and adjustment: illustrative clinical examples,

Pr. Roger W. Jelliffe,

1Oh30 - 10h45 :

Break,

10h45 - 12h00 :

Dosage adaptation in practice, using Win USC*Pack ,

Members of ADCAPT,

12h00 - 14h00 :

Luncheon (included),

14h00 - 15h15 :

NPEM and nonparametric population PK/PD modeling : illustrative examples,

Pr. Roger W. Jelliffe,

15h15 - 15h30 :

Break,

15h30 - 17h00 :

Population modeling with NPEM : practical examples,

Members of ADCAPT

17h00 :

Adjournment

Tenth Workshop 2001 on Adaptive Control of Drug Dosage

Organized by

ADCAPT and the USC Laboratory of Applied Pharmacokinetics

Individualizing Drug Therapy in 2001

Necessities, Difficulties, and Opportunities

Practical Applications (preferential registration for Lyonnais participants)

Lyon - Francheville, France, Friday 29 June, 2001

Service Pharmaceutique, Hospital Antoine Charial, Hospices Civils de Lyon,

40, Avenue de la Table de Pierre,

69340 Francheville

09h00 - 09h15 :

Welcome,

Pr. Roger W. Jelliffe, Dr. Pascal Maire, and ADCAPT,

09h15 - 10h30 :

Win USC*Pack and dosage adaptation and adjustment: illustrative clinical examples,

Pr. Roger W. Jelliffe,

1Oh30 - 10h45 :

Break,

10h45 - 12h00 :

Dosage adaptation in practice, using Win USC*Pack ,

Members of ADCAPT,

12h00 - 14h00 :

Luncheon (included),

14h00 - 15h15 :

NPEM and nonparametric population PK/PD modeling : illustrative examples,

Pr. Roger W. Jelliffe,

15h15 - 15h30 :

Break,

15h30 - 17h00 :

Population modeling with NPEM : practical examples,

Members of ADCAPT

17h00 :

Adjournment

Tenth Workshop 2001 on Adaptive Control of Drug Dosage

Organized by

ADCAPT and the USC Laboratory of Applied Pharmacokinetics

Individualizing Drug Therapy in 2001

Necessities, Difficulties, and Opportunities

Lyon, France 27-29 June, 2001

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REGISTRATION FORM

Please print it out, fill it out, and fax or mail it to the Secretariat (see below).

Last Name :

First Name :

Position :

Organization :

Address :

 

City and Postal code :

Country :

Telephone :

Fax :

Email :

I would like to go to the get-together dinner (please circle one) YES NO

Experience in clinical pharmacokinetics (please circle one) :

none modest moderate advanced

Registration fees :

Payment

Crédit Lyonnais, Lyon, France – bank #30 002 - 01036 - clé RIB 74

15, cours Gambetta, 69003 Lyon, France, tel : (33) 04 78 60 52 50

Secrétariat

Joëlle Baffie, ADCAPT – Pharmacy Service, Hospital A. Charial, 40 avenue de la Table de Pierre, 69340 Francheville, France ; tel : (33) 04 72 32 34 87, fax : (33) 04 72 32 39 08, email : adcapt@cismsun.univ-lyon1.fr

International Secrétariat : Michel Ducher, same address, phone, mail, email : adminstrateur@mduch.org