THE CONDUCT OF IN VITRO STUDIES TO ADDRESS TIME-DEPENDENT INHIBITION OF DRUG METABOLIZING ENZYMES: A PERSPECTIVE OF THE PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA (PhRMA)

نویسندگان

  • Scott W. Grimm
  • Heidi J. Einolf
  • Steven D. Hall
  • Kan He
  • Heng-Keang Lim
  • John Ling
  • Chuang Lu
  • Amin A. Nomeir
  • Eleanore Seibert
  • Konstantine W. Skordos
  • George R. Tonn
  • Robert Van Horn
  • Regina W. Wang
  • Y. Nancy Wong
  • Tian J. Yang
  • Scott Obach
چکیده

Allergan Inc., Irvine, CA (KHJL), Amgen Inc., South San Francisco, CA (GT), AstraZeneca Pharmaceuticals, Wilmington, DE (SWG), Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT (ES), Bristol-Myers Squibb Co., Princeton, NJ (KH), Eisai Research Institute, Andover, MA (YNW), Eli Lilly and Company, Indianapolis, IN (SDH), GlaxoSmithKline, King of Prussia, PA (KWS), Hoffmann-La Roche, Nutley, NJ (TJY), Johnson & Johnson Pharmaceutical Research Institute, Raritan, NJ (HKL), Merck Research Laboratories, Rahway, NJ (RWW), Millennium Pharmaceuticals, Inc., Cambridge, MA (CL), Novartis Pharmaceuticals Corporation, East Hanover, NJ (HJE), Pfizer Inc., Groton, CT (RSO), Sanofi-Aventis, Malvern, PA (RVH), Schering-Plough Research Institute, Kenilworth, NJ (AAN) DMD Fast Forward. Published on April 9, 2009 as doi:10.1124/dmd.109.026716

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

منابع مشابه

The conduct of in vitro studies to address time-dependent inhibition of drug-metabolizing enzymes: a perspective of the pharmaceutical research and manufacturers of America.

Time-dependent inhibition (TDI) of cytochrome P450 (P450) enzymes caused by new molecular entities (NMEs) is of concern because such compounds can be responsible for clinically relevant drug-drug interactions (DDI). Although the biochemistry underlying mechanism-based inactivation (MBI) of P450 enzymes has been generally understood for several years, significant advances have been made only in ...

متن کامل

In vitro and in vivo induction of cytochrome p450: a survey of the current practices and recommendations: a pharmaceutical research and manufacturers of america perspective.

Cytochrome P450 (P450) induction is one of the factors that can affect the pharmacokinetics of a drug molecule upon multiple dosing, and it can result in pharmacokinetic drug-drug interactions with coadministered drugs causing potential therapeutic failures. In recent years, various in vitro assays have been developed and used routinely to assess the potential for drug-drug interactions due to ...

متن کامل

The conduct of in vitro and in vivo drug-drug interaction studies: a Pharmaceutical Research and Manufacturers of America (PhRMA) perspective.

Current regulatory guidances do not address specific study designs for in vitro and in vivo drug-drug interaction studies. There is a common desire by regulatory authorities and by industry sponsors to harmonize approaches, to allow for a better assessment of the significance of findings across different studies and drugs. There is also a growing consensus for the standardization of cytochrome ...

متن کامل

PhRMA white paper on ADME pharmacogenomics.

Pharmacogenomic (PGx) research on the absorption, distribution, metabolism, and excretion (ADME) properties of drugs has begun to have impact for both drug development and utilization. To provide a cross-industry perspective on the utility of ADME PGx, the Pharmaceutical Research and Manufacturers of America (PhRMA) conducted a survey of major pharmaceutical companies on their PGx practices and...

متن کامل

Perspective The Conduct of in Vitro Studies to Address Time-Dependent Inhibition of Drug-Metabolizing Enzymes: A Perspective of the Pharmaceutical Research and Manufacturers of America

Time-dependent inhibition (TDI) of cytochrome P450 (P450) enzymes caused by new molecular entities (NMEs) is of concern because such compounds can be responsible for clinically relevant drug-drug interactions (DDI). Although the biochemistry underlying mechanism-based inactivation (MBI) of P450 enzymes has been generally understood for several years, significant advances have been made only in ...

متن کامل

ذخیره در منابع من


  با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

عنوان ژورنال:

دوره   شماره 

صفحات  -

تاریخ انتشار 2009