AGAH-Workshop “Introduction into Basic Principles of Pharmacokinetics”
AGAH Workshop, Oberursel
Pharmacokinetics – prerequisite and at the same time “door opener” for understanding pharmacology!
This workshop, developed by experienced specialists from industry, CRO and consultancy, offers an entrée to physiological background, measures and characteristics of pharmacokinetics. It helps to understand study design and evaluation of PK studies and the conclusions drawn from the results.
The workshop has been developed for clinical investigators, project leaders, project managers and monitors as well as PhD students in industry, hospitals, university and CROs. The knowledge obtained in this applied introductory course helps beginners in pharmacokinetics obtaining the basic knowledge and scientific background for professional handling, evaluation and interpretation of PK data.
Day 1: Tuesday, 05 June 2018
| 08:00 | Registration |
|---|---|
| 08:30 | Welcome and introduction of participants and speakers
Barbara Schug, Oberursel (Germany) |
| 08:45 | Human physiology: what you should know to better understand pharmacokinetics
An overview of physiological characteristics being of (PK)-relevance for Absorption, Distribution, Metabolism and Elimination (ADME) Roland Heinig, Wuppertal (Germany) |
| 09:30 | How to measure what happens in pharmacokinetics: PK metrics of relevance!
An introduction into how one can quantify what the body does to the drug, i.e. which measures describe what happens to the drug including relevant methods of calculation Helmut Schütz, Vienna (Austria) |
| 10:15 | Break |
| 10:30 | In vitro ADME & preclinical PK
Description of in vitro ADME parameters, such as Cytochrome P450 & drug transporter inhibition, drug absorption, plasma protein binding, and metabolic clearance; explanation of preclinical animal PK results and their translation to the human situation Thomas Arnhold, Biberach (Germany) |
| 11:30 | Human PK studies Ia: bioequivalence, food interaction and drug-drug-interaction studies – Part 1
Presentation of basic principles and design features such as choice of dosing, treatment and sampling schedule, evaluation approaches as well as population characteristics Ralph-Steven Wedemeyer, Oberursel (Germany) |
| 12:00 | Discussion and Questions |
| 12:30 | Break |
| 13:30 | Human PK studies Ib: bioequivalence, food interaction and drug-drug-interaction studies – Part 2
Presentation of basic principles and design features such as choice of dosing, treatment and sampling schedule, evaluation approaches as well as population characteristics Ralph-Steven Wedemeyer, Oberursel (Germany) |
| 14:30 | Human PK studies IIa: Special populations characteristics considering liver, kidney and age – Part 1
Assessment of factors that relevantly impact PK in patients in adequately designed clinical trials considering authorities’ requirements Roland Heinig, Wuppertal (Germany) |
| 15:00 | Break |
| 15:15 | Human PK studies IIb: Special populations characteristics considering liver, kidney and age – Part 2
How to assess factors that relevantly impact PK in patients in adequately designed clinical trials considering authorities’ requirements Roland Heinig, Wuppertal (Germany) |
| 16:15 | Hands-on clinical PK – the practical exercise:
How to design your PK program? An exercise with the goal to plan your own clinical PK program based on a preclinical data set All |
| 17:45 | Discussion and Questions |
| 18:15 | End of Day 1 |
Day 2: Wednesday, 06 June 2018
| 08:30 | Introduction to biologics: what you should know to understand their pharmacokinetics
An overview of their molecular characteristics which interfere with pharmacokinetics – which types, characteristics and differences are of relevance Stephan Glund, Biberach (Germany) |
|---|---|
| 09:15 | Human PK – What’s different in biologics? Part 1
An introduction into bioanalytical methods, antibody development and their assessment, specificities in ADME, TMDD, immunogenicity, drug-drug interaction and comparability / biosimilars Stephan Glund, Biberach (Germany) |
| 10.00 | Break |
| 10:15 | Human PK – What’s different in biologics? Part 2
An introduction into bioanalytical methods, antibody development and their assessment, specificities in ADME, TMDD, immunogenicity, drug-drug interaction and comparability / biosimilars Stephan Glund, Biberach (Germany) |
| 11:00 | Human PK studies III: interplay between biopharmaceutics and absorption
What you should know about galenics and biopharmaceutics to understand the interplay between formulation principles and pharmacokinetics Ralph-Steven Wedemeyer, Oberursel (Germany) |
| 12:30 | Discussion and Questions |
| 13:00 | Break |
| 14:00 | Human PK studies IV: Mass balance / Metabolism
Whatever goes in should get out! Thomas Arnhold, Biberach (Germany) |
| 14:45 | Pitfalls in BA/BE:
Attempts in beating Murphy’s law: Learnings from failures in study design, bioanalytics and statistics Helmut Schütz, Vienna (Austria) |
| 15:30 | Break |
| 14:45 | Where all ends meet – PK information in the label
Review of a PK program – What, When, How – and Why? Wolfgang Mück, Wuppertal (Germany) |
| 17:00 | Discussion and Questions |
| 17:35 | End of Day 2 |
English
Attendance Fees
| 680€ | Non-Members |
|---|---|
| 430€ | Member of AGAH, EUFEMED or one of the VKliPha-Societies or Junior Scientist up to the age of 30 |
The participation fee is per person. Please note, according to §4 para 22 German turnover tax law, registration and workshop fees are exempt from VAT. Registration fees are charged and collected on behalf of AGAH e.V.
All bookings are subject to change
Registration Deadline: May 21, 2018
Dr. Thomas Arnhold
Head of Data Evaluation and Reporting,
Clinical PK/PD
Boehringer Ingelheim Pharma GmbH & Co. KG
Biberach (Germany)
Dr. Stephan Glund
Head of Team 2
Project Clinical Pharmacokineticists, Clinical PK/PD
Boehringer Ingelheim Pharma GmbH & Co. KG
Biberach (Germany)
Dr. Roland Heinig
Director PK Exp
ert, Clinical Pharmacokinetics,
Cardiovascular
Bayer AG, Pharmaceuticals
Wuppertal (Germany)
Dr. Wolfgang Mück
Head of Clinical Pharmacokinetics, Cardiovascular
Bayer AG, Pharmaceuticals
Wuppertal (Germany)
Helmut Schütz
BEBAC – Consultancy Services for Bioequivalence and
Bioavailability Studies
Vienna (Austria)
Dr. Ralph-Steven Wedemeyer
Advisor Biopharmaceutics;
Head of Pharmaceutical Technology
SocraTec R&D GmbH
Oberursel (Germany)
CSi Hamburg GmbH
Conferences | Symposia | Incentives
Goernestraße 30
20249 Hamburg
Germany
phone: +49 40 30770300
fax: +49 40 30770301
e-Mail: agah-meetings ( a t ) csihamburg.de
Association for Applied Human Pharmacology (AGAH) e.V.
office: Goernestraße 30
20249 Hamburg
phone: +49 170 7844438
e-Mail: info ( a t ) agah.eu
Workshop Fee
400 € Non-Member
300 € Member of AGAH | EUFEMED and DGKliPha or young scientistics until the age of 30 years
100 € Member of Regulatory Agencies and ethics commission
Delegate number is limited to 70 persons.
Final Registration: November 1, 2019
5. Juni 2018 - 6. Juni 2018
AGAH-Workshop “Introduction into Basic Principles of Pharmacokinetics”
AGAH Workshop
Oberursel
Deutschland