Covariate hierarchy

Dear Stephen and all other NMusers, Stephen Duffull wrote yesterday: Perhaps a slightly more generic framework is to consider that covariates naturally align to a hierarchical framework,... Now, when we consider size (e.g. lean body mass) a universal covariate for pharmacokinetics, shouldn't we write Phase I (dose escalation) protocols for just about all new drugs (not only anticancer drugs) with doses based on the size of the volunteers (patients)? What do my colleagues from industry and the regulatory agencies think? Joachim __________________________________________ Joachim GREVEL, Ph.D. MERCK SERONO International S.A. Exploratory Medicine 1202 Geneva Tel: +41.22.414.4751 Fax: +41.22.414.3059 Email: [EMAIL PROTECTED] ----------------------------------------- This message and any attachment are confidential, may be privileged or otherwise protected from disclosure and are intended only for use by the addressee(s) named herein. If you are not the intended recipient, you must not copy this message or attachment or disclose the contents to any other person. If you have received this transmission in error, please notify the sender immediately and delete the message and any attachment from your system. Merck Serono does not accept liability for any omissions or errors in this message which may arise as a result of E-Mail-transmission or for damages resulting from any unauthorized changes of the content of this message and any attachment thereto. If verification is required, please request a hard-copy version. Merck Serono does not guarantee that this message is free of viruses and does not accept liability for any damages caused by any virus transmitted therewith.