Entries by Christopher Chengelis

Archiving

I am looking for an independent archiving facility that can handle not only paper, CD's, wet formalin fixed tissues and histology slides, but also frozen tissues at -80. Any recommendations?
Thanks
Chris Chengelis
...

 

CRL Reports

Has anybody else noted changes in CRL reports ? I recently
received two 28-Day  GLP studies to
review  from CRL and found they both had very
 abbreviated Material and Methods Sections,
 basically consisted of an Introduction,
a description of the test article,  a
tabular summary of study design, a statement that the study was conducted
according to protocol except as noted in the deviations, a tabular summary of the
deviations, a list of the computer system used, and a statement on sample
disposition. No description of the endpoints assessed.

When  I queried the SD
and this was  his/her response.  “ This is our new template (we began using
it in August 2020) …the biggest change is to the materials and methods section,
and the intent is to reduce redundancies between the protocol and the report.
It has streamlined both the generation and the review of reports and reduces
the time for the report to be sent out. It is indeed compliant with the
GLPs”

I will be the first to admit 
that I am an old warhorse  to whom
change may come with some difficulty, but this bothers me on several levels.  I will not, however, go into any of that here.
In so far as I can tell, there was no discussion of this major change by a
major CRO on the RTC site or elsewhere. While we will  all have opinions on what should be in the
final report, I would like to know if anybody has experience with  this new CRL standard format and found that it
was  accepted  by the Sponsor and by whatever agency to which
the report  was submitted. Chris Chengelis...

 

Drug Metabolism by Gut Microbiota

Hello Comrades,
I have a client that would like to try an assess the influence of the gut microbiome on the ADM/PK of a drug candidate and, in particular, its metabolites. Does anyone have any suggestions for or experience with a provider that can provide these services?. Thanks. Chris Chengelis...

 

Monoclonal Antibody Analysis

Greetings RTCer's,
I am trying to put together a short list of reliable laboratories with demonstrated expertise in the bioanalysis of monoclonal antibodies in preclinical studies. Does anybody have any experiences that they would like to share? Thank you in advance for your help.

Chris Chengelis...

 

Combined cardiovascular and pulmonary assessment in the dog

I have a safety pharmacology package to run. I was anticipating the standard four studies: In vitro HERG, rat neurobehavioral, rat pulmonary, and dog cardiovascular. One of the bidding CRO's recommended that my client forgo the pulmonary rat study, but rather roll the pulmonary function together with the canine cardiovascular study. The technology for performing such combination studies has been available for at least 10 years. Has anybody had experience submitting combined canine cardiovascular/pulmonary study data to the FDA? Have the data been acceptable?
Thanks...