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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AIT Bioscience Offers New Screening Level Assay

AIT Bioscience Offers New Screening Level Assay     A fit-for-purpose approach to bioanalytical assay support balances intended use of data with regulatory requirements and budgets. FDA regulated studies (GLP Tox or Clinical) require the use of a fully validated bioanalytical assay. However, for non-regulated studies sponsors often ask themselves, and their bioanalytical CRO partners, … read the full article » »

Categories: Electronic Lab Notebooks (ELN), Ligand Binding Assays (LBA), Screening Assay



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AIT Bioscience Strengthens its Team with Recent Hires

AIT Bioscience (AITB) continues to expand its team to add breadth and depth to our areas of expertise. We are excited to introduce three new employees, who have already been great assets to AITB.     John Pirro     John Pirro recently joined AITB’s business development team. John earned a B.S. in Cell Biology … read the full article » »

Categories: Ligand Binding Assays (LBA)



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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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AIT Bioscience Featured in Contract Pharma

As sponsors transition their programs from preclinical animal Tox studies to human clinical trials, sponsors turn to AIT Bioscience (AITB) to help understand the potential issues that may arise with their bioanalytical PK assays. In Contract Pharma’s October issue, AITB tackles this topic to highlight where some unexpected challenges and expenses can arise (Robust Assay … read the full article » »

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AIT Bioscience Expands Our Breadth and Depth with New Hires

AIT Bioscience is expanding! As part of this growth we’ve added two new members to our team:     Qian Li began working for AITB as a Sr. Scientist II in our LC-MS/MS assay development and validation group. She is originally from China and received a master’s degree in organic chemistry there. She then received … read the full article » »

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Antibody Drug Conjugate Analysis: How Partnering with a Bioanalytical CRO Can Ease Preclinical ADC Programs

By: Frank Spriggs, Ligand Binding Assay Group Leader, and Ashley Brant, Program Manager   The potential of antibody drug conjugates (ADCs) to provide targeted therapies for cancers and other devastating diseases have made them popular candidates for drug development programs. However, as we discussed recently in Drug Discovery and Development, the failure of several ADCs … read the full article » »

Categories: Biomarkers, LC-MS/MS Methods, Ligand Binding Assays (LBA), Partnerships



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Continuing to Expand our Capacity at AIT Bioscience

2016 is turning into a great year for AIT Bioscience (AITB) and our sponsors. Funding in the biotech market is up sharply over previous years and sponsors are moving programs forward at a rapid pace. From early preclinical non-GLP through clinical phase of development, our clients are pushing for more capacity to shorten program lead-times. … read the full article » »

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Therapeutic Peptides – Toeing the Line of Small and Large Molecule Bioanalysis

By: Bo Kowalczyk, Vice President of Business Development The pharmaceutical industry is so abuzz with the potential for biologic therapeutics that we often forget about peptide therapy. Despite boasting desirable qualities – low toxicity, high specificity, and high potency – the adoption of peptides into treatments faces many hurdles (Table 1). Design strategies that improve … read the full article » »

Categories: LC-MS/MS Methods, Ligand Binding Assays (LBA)



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What Level of Bioanalytical Method Validation is Right for My Early Stage Drug Development Study?

By: Franklin Spriggs, Ligand Binding Assay Group Leader; Ashley Brant, Program Manager During late phase drug discovery, everyone follows well established FDA bioanalytical method validation guidelines. However, opinions vary widely about what validation is necessary for early- to mid-phase studies. We are often asked by our clients: “How robust do I need this assay to … read the full article » »

Categories: LC-MS/MS Methods, Ligand Binding Assays (LBA), Partnerships



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