Integrating in-vitro dissolution testing, pharmacokinetics and biostudies for solid dosage formulation

Today, in-vitro dissolution testing is very frequent method used in development and characterization. To avoid possible failures, its integration with pharmacokinetics and biostudies is a must.

Here is a great tip from Dr. Malcolm Ross, President, Generapharm, expert trainer of the Bioequivalence, Dissolution & IVIVC Training.

The ultimate goal in the development of solid dosage forms is to ensure that the drug substance is "packaged" in a form (tablet-capsule etc.) in such a way that it releases in the body at the right time, at the right speed and in the right amount in order to achieve the appropriate therapeutic effect. Whereas it would be ideal to monitor all formulations by carrying out pharmacokinetic studies (in-vivo) this is obviously impractical and therefore we are driven to use surrogate tests (i.e. dissolution/in-vitro) and look for justifications that these surrogate tests do represent what is happening in the body (in-vivo/in-vitro correlation). It is only by looking at these studies in an integrated fashion that you can hope to understand how to design and interpret both dissolution testing and bioequivalence studies.”

  • Dr. Malcolm Ross
  • President
  • Generapharm, Switzerland
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Join the dialogue and integrate your in-vitro dissolution testing, pharmacokinetics and biostudies for solid dosage formulations at the upcoming training!