Replies to post #37299 on Intellipharmaceutics International Inc. (IPCI)

[wimuskyfisherman]

So Mopar the question is now how long to analyze and write up study info?

Take a look at volume plot today. Morning extremely high volume and price went up. Then in the afternoon volume subsided and it went down on relatively low volume.

[tilator]

Studies completed, Pending analytics.


https://ir.intellipharmaceutics.com/press-releases/detail/178/intellipharmaceutics-announces-completion-of-the-clinical

Wimusky wrote:

So Mopar the question is now how long to analyze and write up study info?

It does not take too long.

Looks like they really can apply before end of november.

[doogdilinger]

The abuse liability studies for the intranasal route of abuse commenced in May 2018 with subject screening, while the studies to support abuse-deterrent label claims for the oral route of abuse commenced in June 2018. The clinical part of both studies has now been completed. Bioanalytical samples and statistical analysis for such studies are pending. An update on the results will be provided once the analysis is complete.

Statistical considerations for assessment of bioanalytical incurred sample reproducibility.
Hoffman D1.
Author information


Abstract
Bioanalytical method validation is generally conducted using standards and quality control (QC) samples which are prepared to be as similar as possible to the study samples (incurred samples) which are to be analyzed. However, there are a variety of circumstances in which the performance of a bioanalytical method when using standards and QCs may not adequately approximate that when using incurred samples. The objective of incurred sample reproducibility (ISR) testing is to demonstrate that a bioanalytical method will produce consistent results from study samples when re-analyzed on a separate occasion. The Third American Association of Pharmaceutical Scientists (AAPS)/Food and Drug Administration (FDA) Bioanalytical Workshop and subsequent workshops have led to widespread industry adoption of the so-called "4-6-20" rule for assessing incurred sample reproducibility (i.e. at least 66.7% of the re-analyzed incurred samples must agree within +/-20% of the original result), though the performance of this rule in the context of ISR testing has not yet been evaluated. This paper evaluates the performance of the 4-6-20 rule, provides general recommendations and guidance on appropriate experimental designs and sample sizes for ISR testing, discusses the impact of repeated ISR testing across multiple clinical studies, and proposes alternative acceptance criteria for ISR testing based on formal statistical methodology.
https://www.ncbi.nlm.nih.gov/pubmed/19669410

An assessment of the 4-6-20 rule for acceptance of analytical runs in bioavailability, bioequivalence, and pharmacokinetic studies.
Kringle RO1.
Author information


Abstract
A recent conference report described a decision rule, hereafter referred to as the 4-6-20 rule, for acceptance/rejection of analytical runs in bioavailability, bioequivalence, and pharmacokinetic studies. This procedure requires that quality control specimens at three concentrations (low, medium, and high) be assayed in duplicate in each run. For run acceptance, at least four of the six assay values must be within +/- 20% of their respective nominal concentrations, and at least one of the two values at each concentration must be within these limits. An inherent flaw in this decision rule is that the risk of rejecting runs, when the assay performance has in fact not deteriorated, varies for each assay and is neither known nor controlled. In this paper simulation methods are used to evaluate the operating characteristics of the 4-6-20 rule in comparison to those of classical statistical quality control procedures.
https://www.ncbi.nlm.nih.gov/pubmed/8058615

[doogdilinger]

Anyways credit where credit is due as it can only be viewed as a positive that IPCI was able to complete the oral and intra-nasal studies so quickly. No clue if the news is gonna help the FUD factor and erosion in this stock...but for once IPCI has put out positive news of some kind for the first time since launching the intra-nasal studies in May.