jamesmuller

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Role of In Vitro ADME in Drug Discovery
 Development
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• Understanding your new chemical entitys (NCEs)
  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. 

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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 articles 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 candidates
  ability to hit its target and could cause drug
  failure.

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Importance of In Vitro ADME in Drug Discovery
Development

• The very nature of in vitro  research often 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.  

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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. 

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Thanks!

• Any questions?You can find me at
• www.iontox.com