Tadalafil zeigt eine konstante Resorption im Gastrointestinaltrakt, mit maximalen Plasmaspiegeln nach rund zwei Stunden. Der Wirkstoff verteilt sich gut im Gewebe und weist eine hohe Plasmaproteinbindung auf. Seine lange Halbwertszeit erlaubt eine verlängerte Wirkphase. Der Metabolismus erfolgt über das hepatische Enzymsystem CYP3A4, mit der Bildung inaktiver Metaboliten. Exkretion geschieht primär über den Stuhl. Die Häufigkeit von Nebenwirkungen steigt mit der Dosis, wobei vor allem vasodilatatorische Effekte dominieren. Ein gängiger Bezugspunkt in pharmakologischen Analysen ist cialis ohne rezept, das mit dieser Wirkstoffklasse assoziiert ist.
Microsoft powerpoint - noymer-massmedic-2011.ppt
Drug-Device Combination Products Peter D. Noymer, Ph.D. Vice President, Product R&D MassMEDIC / March 3, 2011 Background – current experience Background – “personal pipeline” AERx® - diabetes AERx® - other Intraject® - migraine Staccato® - agitation Staccato® - other CNS
– 2 companies (Aradigm, Alexza), approximately 12 years– One product approved (SumavelTM DoseproTM – Zogenix – approved July 2009)– One NDA in the review process (Staccato® Loxapine)– 8-10 other development candidates
• There are an additional ~20 novel drug-device combination products
being developed just for inhalation at other companies
Some of the challenges … Business Engineers Chemists Small companies Large companies Device regulations Drug regulations Business & Biology
• Fundamental for almost any medical product
– Businesses work to control risk, optimize outcomes & financial returns
– Human biology / physiology is inherently unpredictable
– Portfolio approach – multiple product development efforts, “spread the bets”
– Staged approach – funding tied to advances in progress and risk reduction
Engineers & Chemists
– But combination product must work as a whole system
• Organizational structure & development procedures can
– Scientists & engineers “under the same roof” vs. different management lines
– Product development procedures/practices designed to keep activities in synch
Small & Large Companies
– New/disruptive technologies often from startup companies
– Economic realities drive trend toward partnerships / JV’s / M&A to reach
• Partnerships are just like personal relationships
– Different “personalities” that need to mesh
– Corporate agendas that can get in the way
• Effective partnership management is a good approach
– Many companies employ “alliance management” staff
– Regular care & feeding of any relationship can help avert issues
Drug & Device Regulations
– Ultimately same foundational principles
– Guidelines are evolving on how to blend specific elements
• Application review process becomes more complex
– Multidisciplinary reviews become the norm
– CDER, CDRH and any other divisions that have a key stake
– Sponsor needs to ensure all audiences are considered
Getting there from here … Drug-Device Combination Products Peter D. Noymer, Ph.D. Vice President, Product R&D MassMEDIC / March 3, 2011
The Knowledge Engineering Review , Vol. 23:1, 101–115. c 2007, Cambridge University PressDOI: 10.1017/S0269888907001270 Printed in the United KingdomA context-sensitive framework for lexical ontologiesTONY VEALE and YANFEN HAO School of Computer Science and Informatics, University College DublinE-mail: tony.veale@ucd.ie, yanfen.hao@ucd.ie Human categorization is neither a binary nor a contex
CORRECTION EXERCICE n°5 EXERCICE 5 La prescription médicale ce jour est : - Soluté glucosé à 5 %, 2 litres / 24 h avec : - 2 g de KCl / L - 4 g de NaCl /L Vous disposez d’ampoules de 10 mL à 10 % de KCl, d’ampoules de 20 mL à 20 % de NaCl. Le premier litre de G5 % avec les électrolytes (KCl et NaCl) à été posé à 0 h. Augmentin® 1 g x 2/24 h dans 50 ml de soluté ph
Drug-Device Combination Products
Background – current experience
Background – “personal pipeline”
Some of the challenges …
Business & Biology
Engineers & Chemists
Small & Large Companies
Drug & Device Regulations
Getting there from here …
Drug-Device Combination Products