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Tag Archives for bioanalysis

The Value of a Stable-labelled Internal Standard

The years of experience accrued at AIT Bioscience in quantitative bioanalysis allow us to be your trusted partner in bioanalytical method development. Many questions repeatedly come up at the outset of new drug development programs. One question we are asked frequently is whether it is “worth it” to invest in a stable labelled internal standard. … read the full article » »

Categories: News, Special Topics, Uncategorized

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AIT Bioscience Among Inc.’s 5000 Fastest Growing Private Companies

AIT Bioscience Named to Inc. Magazine’s 36th Annual List of America’s Fastest-Growing Private Companies—the Inc. 5000   For the 2nd Time, AIT Bioscience appears on the Inc. 5000 list, Ranking No. 2366 with Three-Year Sales Growth of 153.16%   Indianapolis, IN August 16, 2017 – Inc. magazine today ranked AIT Bioscience NO. 2366 on its … read the full article » »

Categories: Biomarkers, LC-MS/MS Methods, Ligand Binding Assays (LBA), News, Screening Assay

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AIT Bioscience Recognized with Awards at Recent WRIB

  WRIB (Workshop for Recent Issues in Bioanalysis) is an annual gathering of bioanalytical scientists from across the pharmaceutical industry spectrum. Attendees include big pharma and biopharmas, biotechs, CROs and multiple regulatory agencies working on both small and large molecule bioanalysis.   AIT Bioscience showcased its scientific prowess by garnering the Top LC-MS/MS Small Molecule … read the full article » »

Categories: Ligand Binding Assays (LBA), Proteins and LC-MS/MS, Special Topics

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Bioanalytical Considerations for your Dermal Pharmaceutical Programs

Bioanalytical Considerations for your Dermal Pharmaceutical Programs Does your drug require sustained release or suffer from first pass metabolism losses?   Have you considered transdermal delivery via cream gel or patch?   How does bioanalysis differ for oral or dermal delivery?   The dermis is the largest organ of the human body and provides a … read the full article » »

Categories: LC-MS/MS Methods, Screening Assay, Special Topics

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Involved in Ocular Therapeutics? Thoughts on a successful PK program

As our population ages there comes an increased demand for therapies to treat age related ocular diseases such as Age-related Macular Degeneration (AMD), glaucoma, diabetic retinopathy and dry-eye.  In fact, the global market for ocular drugs is expected to reach $21.6 billion by 2018 according to a Transparency Market Research article.   Successful bioanalysis in … read the full article » »

Categories: Special Topics

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Bioanalytical Method Development Strategy for Proteins

By: Michael Schneider   A bioanalytical method development strategy is presented for quantitative protein analysis by LC-MS/MS when no capture antibody is available for bioanalytical sample clean-up or enrichment. A robust quantitative method for protein therapeutics can be quickly developed and performed in less than a day by using the Perfinity Workstation for on-line sample … read the full article » »

Categories: LC-MS/MS Methods, Proteins and LC-MS/MS

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Strategy for Designing Electronic Lab Notebook Workflows Both Flexible Enough for R&D and Comprehensive Enough for Regulated Work

By: Brian D. Beato*; April L. Pisek; Jessica M. White   Electronic laboratory notebook (ELN) workflows are typically designed for either research or regulated use. Documentation requirements for regulated sample analysis are unnecessarily comprehensive and rigid for free-form research. Creating and validating separate templates targeted for different uses is inefficient. Presented here is a widely applicable, strategy for … read the full article » »

Categories: Electronic Lab Notebooks (ELN)

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A Paper-Free Fully Regulated Bioanalytical Assay Validation of Fentanyl in Human Plasma

By: Brian J. Engel; Michael R. Pugh; Barbara J. Carel; and Ronald E. Shoup   A fully validated bioanalytical method for fentanyl in EDTA human plasma spanning 5.00 – 5000 pg/mL was generated in a completely paperless laboratory. The model presented illustrates the application and interaction of multiple electronic laboratory systems to execute and document a validation … read the full article » »

Categories: Electronic Lab Notebooks (ELN), LC-MS/MS Methods

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Using Electronic Lab Notebook Functionality for Validating Electronic Lab Notebook Workflows

By: Brian D. Beato*; Timothy P. Grever; Laurel E. Branstrator   The use of electronic laboratory notebooks (ELNs) for regulated bioanalysis requires validation of numerous ELN workflows (templates). Presented here is a strategy for using common ELN functionality to validate workflows such that reviews are more efficient and comprehensive than for traditional software validation. The resulting electronic records … read the full article » »

Categories: Electronic Lab Notebooks (ELN)

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Qualification of a Robotic Liquid Handler to Prepare Bioanalytical Runs

By: Ron Shoup and Michael Pugh   Bioanalytical method validations require the preparation of both routine and specialized samples. However, the process is similar from one molecule to the next, and much of the work can be handled robotically if terms and procedures can be standardized.   To read more see the attached pdf.   … read the full article » »

Categories: LC-MS/MS Methods

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