E-DRUG: POPP PKPD Draft discussion paper

[David Addison <addisond@dia-swap.org.au>]

E-drug: POPP PKPD Draft discussion paper
---------------------------------------------

      Population Pharmacokinetics and Pharmacodynamics:
                    An Underutilised Resource?
      Conference in Canberra, Australia 3-5 December 1997

Population pharmacokinetics and pharmacodynamics (PKPD) is a specific
application of the population approach to describe the relationship
between dose and concentration (PK) and concentration and effect (PD).
It is commonly used to discover how typical differences between
individuals eg. in size or age, can be used to predict individualised
doses. It also offers an alternative to traditional methods for
hypothesis testing about the effects of drugs and for defining
dose-effect relationships.

The above DIA Conference was convened to discuss the role of PKPD in
drug evaluation and development. DIA was asked by the Australian
Drug Evaluation Committee (ADEC) to convene the meeting as questions
about the use of the population approach had arisen many times
during the drug evaluation process in Australia. The ADEC was of the
opinion that the population approach was particularly useful for
paediatric patients and, indeed, one of the recommendations from the
ADEC Working Party on the Registration of Drugs for use in Children,
was that the population approach could be used more in PKPD studies
to provide valuable information required for the safe and effective use
of drugs in neonates, infants and children.

If you would like a copy of the ADEC Report of the Working Party on
the Registration of Drugs in Children, dated October 1997 please
contact the ADEC Secretariat at: brenley.milsom@health.gov.au

The Conference meeting ventured more widely than the application of
the population approach in paediatric, infant and neonatal age groups
and discussed the application of PKPD methods where these techniques
could be particularly useful to assist with optimal dosing and to assist
with registration and evaluation of drugs.

PAGANZ (Population Approach Group in Australia and New Zealand) was
formed as a result of the Conference. It plans to maintain close contact
with the European group (PAGE - Population Approach Group in
Europe). PAGANZ encourages interested parties to contact one of the
principle authors of the discussion paper to register such interest and
join the circulation list.

A discussion paper was drafted by contributors to a DIA Conference
held on the above topic in Canberra, Australia on 3 - 5 December,
1997. The draft has been made available on the DIA Homepage Website
http://www.diahome.org to encourage comment from the DIA Membership
and interested parties before the document is finalised for publication.
The final paper is to be published in the Drug Information Journal in
1998.

Principal Authors:
Susan E Tett (1), s.tett@pharmacy.uq.edu.au
Nicholas HG Holford (2), n.holford@auckland.ac.nz
Andrew J McLachlan (3), andrewm@pharm.usyd.edu.au

1. School of Pharmacy, University of Queensland, Brisbane, Qld 4072,
    Australia (*author for correspondence)
2. Dept of Pharmacology & Clinical Pharmacology, University of
    Auckland, New Zealand
3. Department of Pharmacy, University of Sydney, NSW 2006, Australia

PLEASE visit the DIA Homepage Whats New, download the draft
discussion paper and e-mail YOUR COMMENTS TO Sue Tett at:
s.tett@pharmacy.uq.edu.au

THE DEADLINE FOR COMMENTS is Monday 23 March 1998.
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