We´re looking forward to meeting many old acquaintances again and sure to meet many new people as we participate once more in the Bio-Europe conference in Hamburg!

See you soon!

"A short bioanalytical feasibility is the most efficient way preparing optimally for first in-vivo studies" was the message of the presentation given by Christian Kikuta and Martin van Dam.
The afternoon was dedicated to the subject "Preparing for 1st In-Man / Preclinical Strategies", organized by LISA, the Austrian life science cluster organization.

In the early phase of developing a compound obviously the bioanalytical behavior is vastly unknown. Yet the upcoming TOX or Dose Range Finding Study want to be planned optimally, in the light of the large lumps of budget absorbed by them.

A bioanalytical feasibility is a 2-4 day ballpark investigation of the bioanalytical behavior in plasma (or respective matrices). Output are rudimentary data on: stability in plasma, detectability, linearity, rough limits of detection and selectivity.

In combination with a pilot pre-clinical study administering the compound to 2-3 rodents, even important first information on bioavailibility can be gained, such as first-pass-effect, metabolism or protein binding.

The benefits are obvious:
- Reduction of Risk and disclosing latent "bad news"
- Estimation of effort and cost for upcoming in vivo trials
- Knowing scope of data to expect of pre-clinics
- Improved position towards VCs and authorities

In context with in-vivo pilot study:
- Pre-conclustions on administrative route
- Impression of bioavailibility / metabolism
- Orientation for dose range

Summary: Cut Risk and Cost with Preliminary Data.

Starting with September 2012 pharm-analyt´s head of QA/QM, Timo Kretzschmar, will be lecturing “QM Systems in Biotech and Pharmacy” at Campus Tulln (FH Wiener Neustadt).

Dr. Kretzschmar is a remarkable expert in quality management in context of pharma and Life Science. He has an intriguing mix of knowledge, experience and excitement for his subjects GLP and GMP.
His record of lecturing on academic level goes back to 2004.

One of the focal points of the upcoming 3rd Focus Meeting in Brussels June 12-13 will be the topic of tissue analysis.

We´re all familiar with the main challenges of quantifying a substance from tissue material:
- Selecting a representative section (especially with large organs)
- Sample preparation / homogenization
- Recovery
- Matrix effects

Hermann will draw from his long standing experience in preparation of various types of biological tissue and successful analysis with HPLC-MS/MS.

Some of it, by the way, is laid out in his book "HPLC Methods for Clinical Pharmaceutical Analysis".

Meet us at BIO International Convention in Boston June 18-21!

pharm-analyt will be represented at the Austrian booth (No. 3265).

We are looking forward to seeing you in Boston!