Application (validation) of convolution technique using spreadsheet software for predicting plasma drug levels from dissolution results – some examples

Recently a simple and practical approach has been suggested to predict plasma drug concentration-time profiles from drug dissolution results (link) without conducting a concurrent bio-study. The following citations describe application and usefulness of such an approach as reported in recent literature (refereed journals) from third-party laboratories.

  1. Solid self-emulsified nanostructures of Lercanidipine hydrochloride: A potential approach to improve the fraction of the dose absorbed. Journal of Drug Delivery Science and Technology, November 2015 (Link)
  2. Sunitinib-eluting beads for chemoembolization: Methods for in vitro evaluation of drug release (link).
  3. In vitro dissolution similarity factor (f2) and in vivo bioequivalence criteria, how and when do they match? Using a BCS class II drug as a simulation example(link).
  4. Establishment of a Bioequivalence-Indicating Dissolution Specification for Candesartan Cilexetil Tablets Using a Convolution Model (link).
  5. Study the effect of formulation variables on drug release from hydrophilic matrix tablets of milnacipran and prediction of in-vivo plasma profile (link).
  6. Prediction of in vivo plasma concentration-time profile from in vitro release data of designed formulations of milnacipran using numerical convolution method (link)
  7. In vitro to in vivo profiling: an easy idea for biowaiver study (link).
  8. Metoprolol-Eudragit Microcapsules: Pharmacokinetic Study using Convolution Approach (link)
  9. Dose regimen of para-aminosalicylic acid gastro-resistant formulation (PAS-GR) in multidrug-resistant tuberculosis (link)
  10. Preparation of acetaminophen capsules containing beads prepared by hot-melt direct blend coating (link)

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