preclinical white papers and articles

  1. Accelerating IND-Enabling Studies With Automated Bioanalysis Workflows 9/2/2025

    Reimagined as automation-first, bioanalysis shifts from being an Investigational New Drug (IND) bottleneck to a catalyst for innovation—helping companies move therapies forward with greater confidence.

  2. Why Bioanalysis Needs To Break Free From Manual Bottlenecks 9/2/2025

    Bioanalysis remains one of the most persistent bottlenecks in drug development, with CRO's displaying inefficiencies that are no longer operational nuisances but strategic liabilities.

  3. Strategic CMC Considerations For Pre-IND Meetings: Setting The Stage For A Successful TPP 9/1/2025

    In biotechnology, the Pre-Investigational New Drug (Pre-IND) stage is a critical juncture. Explore the pivotal role of Chemistry, Manufacturing, and Controls (CMC) in navigating this phase.

  4. Enhancing The Biosimilar Review Process 8/12/2025

    The biosimilar market is projected to reach over $100 billion in the next five years. Learn how to navigate the expanding landscape and overcome challenges in accessing key clinical information.

  5. Continuing Your Research Mission -- Even As Budgets Tighten 5/12/2025

    Amid growing uncertainty in clinical research funding, including proposed budget cuts from the NIH that threaten indirect support for essential infrastructure, OpenClinica remains a steadfast partner to researchers.

  6. Journey Of A Therapeutic Antibody 5/2/2025

    Delve into the early development journey of a therapeutic antibody and learn about the critical role of robust biomarker strategies and analytical assays.

  7. The Evolving Landscape Of Radiopharmaceuticals In Oncology Research 4/24/2025

    From selecting appropriate targeting molecules to optimizing dosing strategies and managing off-target effects, radiopharmaceutical development demands a tailored and strategic clinical approach.

  8. Blueprint For Early Phase Clinical Pharmacology Studies In Dermatology 4/11/2025

    Explore the landscape of dermatological drug development through a comprehensive framework for rational early-phase dermatological trials, centered around five foundational pillars.

  9. Bladder Cancer: Challenges And Innovations 4/4/2025

    Bladder cancer ranks ninth in incidence and 13th in mortality among cancers. Recent advancements in treatment are transforming the management of advanced bladder cancer cases.

  10. Safety Assessment For Ophthalmic Products 2/20/2025

    Dive into the world of ophthalmic drug development, where careful considerations in the preclinical phase must be taken to facilitate advancement into first-in-human clinical trials.