Dear NONMEM users, two years ago when we started (at Merck Serono) to discuss the necessary QA documents for a "validated" NONMEM system the fact that NONMEM was open-source played a major role in our risk analysis. In fact we conciously decided in favor of open-source software also with regards of other tools (R, PsN, XPOSE) associated with NONMEM. I do not know to which degree system validation according to GxP standards is affected in other commercial enterprices by the fact that NONMEM7 will no longer be open-source. Specifically, I shall address that question here at my new employer (AstraZeneca). I have also proposed to discuss the question of NONMEM system validation at the upcoming PKUK meeting in Birmingham. Please, do not apply the classification 'positive/negative reaction to new encrypted NONMEM code' to my contribution. My work will not be negatively affected by encryption, and I welcome the new estimation methods of NONMEM7. Cheers, Joachim Grevel ___________________________________________________ AstraZeneca R&D Charnwood Clinical Pharmacology & DMPK Bakewell Road, Loughborough, Leics LE11 5RH, England Tel: +44 (0) 1509 645177 [email protected]
-------------------------------------------------------------------------- AstraZeneca UK Limited is a company incorporated in England and Wales with registered number: 03674842 and a registered office at 15 Stanhope Gate, London W1K 1LN. Confidentiality Notice: This message is private and may contain confidential, proprietary and legally privileged information. If you have received this message in error, please notify us and remove it from your system and note that you must not copy, distribute or take any action in reliance on it. Any unauthorised use or disclosure of the contents of this message is not permitted and may be unlawful. Disclaimer: Email messages may be subject to delays, interception, non-delivery and unauthorised alterations. Therefore, information expressed in this message is not given or endorsed by AstraZeneca UK Limited unless otherwise notified by an authorised representative independent of this message. No contractual relationship is created by this message by any person unless specifically indicated by agreement in writing other than email. Monitoring: AstraZeneca UK Limited may monitor email traffic data and content for the purposes of the prevention and detection of crime, ensuring the security of our computer systems and checking Compliance with our Code of Conduct and Policies. -----Original Message----- From: [email protected] [mailto:[email protected]]on Behalf Of Serge Guzy Sent: 03 July 2009 08:56 To: [email protected]; [email protected]; [email protected] Subject: Re: [NMusers] RE: NONMEM 7 Update I do have only one simple question. How many people took advantage from the fact Nonmem was distributed as open source? If we are talking about a very small percentage, is this discussion worthwhile? How many people except bob bauer and may be somebody else I am not aware of are able to follow and understand the cuirrent nonmem code? Serge _____ From: [email protected] To: Ludden, Thomas ; [email protected] Sent: Thu Jul 02 23:46:09 2009 Subject: [NMusers] RE: NONMEM 7 Update Thomas Didn't ICON consider that indeed, this decision might stimulate the divergence of an open-source clade of NONMEM, somewhat like R stemmed out of S-plus? If a small academic group starts to work in that direction, it would certainly be quickly joined by many… Thierry Buclin Univ. Hospital, Lausanne De : [email protected] [mailto:[email protected]] De la part de Ludden, Thomas Envoyé : jeudi, 2. juillet 2009 15:15 À : Eleveld, DJ; [email protected] Cc : Krohn, Anthony Objet : RE: [NMusers] NONMEM 7 Update Dear All: Icon Development Solutions has invested in the further development of NONMEM. By mutual agreement with the University of California at San Francisco, NONMEM 7 is intellectual property belonging to IDS. However, IDS will continue to pay royalties to UCSF. The business plan under which NONMEM 7 was developed calls for the protection of the I.P. involved. In addition, NONMEM 7 contains several updated routines developed and owned by IMSL (Visual Numerics Inc.). Our agreement with IMSL stipulates that we will not distribute their source code. The installer will compile the software but will not allow the unencrypted source code to remain on the users computer. The licensing agreement will also stipulate that any attempt to access the source code will be a violation of the agreement. Some source code will be left unencrypted for various reasons, one being the need for users to change certain values in SIZES and perhaps other resource routines. Tom Thomas M. Ludden Ph.D. Vice-President, Pharmacometrics R&D ICON Development Solutions Tel: + 1 410 696 3040 Mob: + 1 410 258 2411 Fax: + 1 410 480 0776 Email: [email protected] Web: www.icondevsolutions.com _____ The information contained in this email message may contain confidential or legally privileged information and is intended solely for the use of the named recipient(s). No confidentiality or privilege is waived or lost by any transmission error. If the reader of this message is not the intended recipient, please immediately delete the e-mail and all copies of it from your system, destroy any hard copies of it and notify the sender either by telephone or return e-mail. Any direct or indirect use, disclosure, distribution, printing, or copying of any part of this message is prohibited. Any views expressed in this message are those of the individual sender, except where the message states otherwise and the sender is authorized to state them to be the views of XOMA.
