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Role of In Vitro ADME in Drug Discovery & Development

In vitro ADME studies are assays that are used to assess the pharmacokinetic characteristics of a drug represented by the acronym ADME sometimes written ADME-PK to indicate the direct relationship of ADME with pharmacokinetics.<br>

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Role of In Vitro ADME in Drug Discovery & Development

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  1. Role of In Vitro ADME in Drug Discovery & Development

  2. Understanding your new chemical entity’s (NCE’s) pharmacokinetic (PK) parameters is vital to developing a successful drug candidate. In fact, having PK data for an NCE is so important that the United States FDA requires companies applying for an Investigational New Drug (IND) status to submit PK data to show their formula is reasonably safe to enter clinical trials. For over 50 years PK has been described with the 4 letter acronym ADME or absorption, distribution, metabolism, and excretion. 

  3. What are In Vitro ADME studies? In vitro ADME studies are assays that are used to assess the pharmacokinetic characteristics of a drug represented by the acronym ADME sometimes written ADME-PK to indicate the direct relationship of ADME with pharmacokinetics.  The underlying goal of all ADME studies is to understand the test article’s pharmacokinetic parameters to reduce the chances of later-stage drug failure due to poor ADME characteristics. For example, if an NCE is shown to be non-toxic at its therapeutic dose, but the test article has poor intestinal absorption, one component of ADME, this may affect the drug candidate’s ability to hit its target and could cause drug failure.

  4. Importance of In Vitro ADME in Drug Discovery & Development: The very nature of in vitro  researchoften being much more cost effective than in vivo studies means that in vitro studies are run before, or when allowed by regulatory bodies, in place of conventional animal studies.  In vitro ADME studies are then pharmacokinetic cell or tissue based assays that are often run in place of or along with conventional in vivo pharmacokinetic research. In addition to using in vitro ADME studies as preliminary screens, a major benefit of in vitro ADME research is the ability to gain human data via human skin and tissue cultures. This benefit of in vitro ADME studies makes in vitro ADME data a valuable research opportunity into how an NCE is likely to perform in humans.  

  5. Take Away: Are you looking for in vitro ADME contract research services? IONTOX is a biotechnology company known for providing expertise in the area of in vitro toxicology and ADME. For proper in vitro ADME guidance, consider consulting them. 

  6. Thanks! Any questions?You can find me at: www.iontox.com

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