For details, please see here
Why does one require an exhaustive standardization (calibration/PVT/Guidances/training etc.) for the operation of one stirrer type but not for the other when both are used extensively for the same purpose (dissolution)? Does it indicate a misunderstanding of the underlying concept? It appears so! To know more about why both of these stirrers are not suitable for DRUG dissolution testing? See here
This definition/metric needs to be included, as an assessment of practically all other factors such as safety, efficacy, manufacturing and its design and processes etc., are secondary to it. In addition, such a metric can easily be explained to the consumer/patient. For further discussions on the topic, please see the link.
Attached is a copy of a presentation (slides) given last month at Rowan University (New Jersey, United States) as a guest speaker for an online course (link).
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)
Slides from a presentation made at the 2nd Annual Bioequivalence Conference: Intersection between Science and Regulatory Summit, Philadelphia, PA, USA. September 29-30, 2015 link.
