You are here:

Biotech & Biomedical/New IND and estimated dose for children

Advertisement

Expert: - 7/31/2006


Question
Do you know how the dose for children is being estimated based on preclinical data?

Answer
Hi, Uwe,

There are a number of ways of estimating children's doses from preclinical (adult) data - often depends on the therapeutic index of the drug in question (the wider the therapeutic window the less accurate the child's dose needs to be).

Sometimes straight weight-basis i.e. 7kg child gets 1/10 dose of 70kg adult.

More accurate (so they say) is a dose based on body surface area (child's surface area is greater in proportion to its body weight than an adult). There are normograms to calculate surface area from weight and height of child.

All of these may be wrong if clearance of drug in child is significantly different from adult e.g. different metabolism or different route of clearance.

Hope this helps.

Best wishes,

Paul

Biotech & Biomedical

All Answers

Answers by Expert:

Ask Experts

Volunteer

Dr.Paul Skett

Expertise

drug metabolism or biotransformation from basic to advanced, hepatocytes from basic to advanced, drug toxicity and side effects, alcohol clearance and levels

Experience

32 years research experience in above areas, 30 years educational experience in University. Retained expert for numerous legal firms dealing with matters of drugs (legal and illegal)and alcohol.

Education/Credentials
B.Sc(Hons) Biochemistry, University of Liverpool, UK
fil.dr. (Medical Chemistry) Karolinska Institute, Stockholm, Sweden

Fellow of the British Pharmacological Society

Fellow of the Higher Education Academy

©2012 About.com, a part of The New York Times Company. All rights reserved.