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.
- 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)
- Sunitinib-eluting beads for chemoembolization: Methods for in vitro evaluation of drug release (link).
- 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).
- Establishment of a Bioequivalence-Indicating Dissolution Specification for Candesartan Cilexetil Tablets Using a Convolution Model (link).
- Study the effect of formulation variables on drug release from hydrophilic matrix tablets of milnacipran and prediction of in-vivo plasma profile (link).
- Prediction of in vivo plasma concentration–time profile from in vitro release data of designed formulations of milnacipran using numerical convolution method (link)
- In vitro to in vivo profiling: an easy idea for biowaiver study (link).
- Metoprolol-Eudragit Microcapsules: Pharmacokinetic Study using Convolution Approach (link)
- Dose regimen of para-aminosalicylic acid gastro-resistant formulation (PAS-GR) in multidrug-resistant tuberculosis (link)
- Preparation of acetaminophen capsules containing beads prepared by hot-melt direct blend coating (link)
Some related articles from this blog:
- Confusion about IVIVC and predicting plasma drug levels (link)
- Predicting plasma drug levels does not require an IVIVC development. In fact IVIVC cannot be used for such predictions at all, as explained with an example from literature for gliclazide ER products (link)
- Prediction of plasma drug levels from dissolution results for OROS-based nifedipine products (link).
- IVIVC and Predicting of Plasma Drug Levels during Product Development (link).
- Predicting plasma drug levels: Independence of suggested approach of IVIVP (in vitro-to-in vivo profiling) from the nature and source of test products (link).
- Developing an IVIVC: Time Spent = Time Wasted (link).
- Predicting Drug Concentration-Time (C-t) Profiles for Metoprolol Tartrate Tablet Products in Healthy Human Volunteers and a Sub-population Group (link).
- Prediction of blood drug concentration-time (C-t) profiles does not require a deconvolution step (link).
- Predicting Blood Drug Concentration-Time (C-t) Profiles Using Convolution Technique – Valproic Acid (link).
- Predicting Blood Concentrations-Time (C-t) Profiles from Drug Dissolution Results without Developing an IVIVC – Validation (link).
- Estimation of blood levels – Example: 120 mg diltiazem ER capsules (link).
- In Vitro-to-In Vivo Profiling (IVIVP) (Link).
- Different IVIV Relationship Terminologies (link).
- IVIVC – Conflict between practices and objective/intent (link).
- Level A IVIVC – Impractical and unreasonable expectations (link).
- Determining blood concentration-time (C-t) profiles from in vitro dissolution results and product evaluation – carbamazepine (link).
- “Developing IVIVC” and establishing drug concentration-time (C-t) profiles (link).
- Convolution/Deconvolution Techniques – Which one to use and why? (link).
- IVIVC – Convolution/Deconvolution Techniques (link).
