{"id":8779,"date":"2025-08-05T15:19:39","date_gmt":"2025-08-05T13:19:39","guid":{"rendered":"https:\/\/www.quinta.cz\/?p=8779"},"modified":"2025-08-05T15:56:32","modified_gmt":"2025-08-05T13:56:32","slug":"preclinical-bioanalysis-clinical-entry","status":"publish","type":"post","link":"https:\/\/www.quinta.cz\/cs\/2025\/08\/05\/preclinical-bioanalysis-clinical-entry\/","title":{"rendered":"Preclinical Bioanalysis That Accelerates Clinical Entry"},"content":{"rendered":"

Bioanalysis and Pharmacokinetic Expertise for Preclinical Success<\/strong><\/span><\/h4>\n

Robust bioanalytical and pharmacokinetic\/toxicokinetic (PK\/TK) data are essential for safe, efficient drug development. From early discovery to GLP-compliant Investigational New Drug (IND)-enabling studies, successful preclinical programs rely on tailored strategies that reflect the specific behavior of each compound and modality, whether a small molecule, peptide, monoclonal antibody, fusion protein, or complex bioconjugate such as an antibody-drug conjugate (ADC).<\/p>\n

We understand that every molecule and development plan require a tailored approach. That\u2019s why our scientists work closely with your team to define the right bioanalytical strategy, aligned with your compound\u2019s characteristics, study goals, and timelines.<\/p>\n

With deep experience across therapeutic platforms and regulatory frameworks, our laboratories support fit-for-purpose and GLP studies with integrated method development, validated protocols, and regulator-aligned interpretation.<\/p>\n

What is the result for you? Faster transitions, reduced risk, and confident candidate selection.<\/p>\n

To understand how this is achieved in practice, let\u2019s walk through the key analytical milestones that shape preclinical success.<\/p>\n

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Candidate Selection – Pilot PK\/TK Studies<\/strong><\/span><\/h4>\n

Pilot PK studies are often the first in-vivo step to assess a drug\u2019s behavior in the body. These non-GLP exploratory studies are typically used to compare several candidate molecules in parallel, usually compounds of the same modality with different semisynthetic modifications or antibody clones targeting the same receptor.<\/p>\n

Validated methods are not required at this stage, which allows for greater flexibility and faster execution. Our team supports these early programs with fit-for-purpose bioanalysis and rapid turnaround, enabling data-driven clinical candidate nomination.<\/p>\n

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Refining Dose and Safety \u2013 DRF & sophisticated PK\/TK Studies<\/span> <\/strong><\/h4>\n

As candidate molecules (typically the lead and backup molecules<\/em>) are selected, more sophisticated pharmacokinetic and toxicokinetic (PK\/TK) studies are essential to guide final selection and inform safe, effective dosing strategies.<\/p>\n

Dose Range Finding (DRF) studies, typically conducted under non-GLP or GLP-like conditions support the definition of appropriate dose levels, identify early toxicity signals, and provide the foundation for GLP toxicology. These studies often involve repeated dosing, expanded sampling, and detailed exposure profiling to assess accumulation, tolerability, and systemic exposure.<\/p>\n

For both lead and backup compounds, tailored bioanalytical method development and comprehensive PK\/TK analysis using software such as Phoenix WinNonlin ensure that critical exposure data is accurate, interpretable, and ready for integration into subsequent study phases.<\/p>\n

Beyond PK measurements, immunogenicity assessments play a key role in biologics development. Anti-drug antibody (ADA) testing, commonly performed on the MSD platform, and neutralizing antibody (NAb) assays using cell-based formats, provide valuable insights into potential immune responses, supporting compound selection and patient safety.<\/p>\n

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Support Regulatory Framework – GLP Toxicology & pivotal PK\/TK Studies<\/strong><\/span><\/h4>\n

As development progresses toward clinical entry, regulatory authorities require robust, GLP-compliant PK\/TK data to support Investigational New Drug (IND) or Clinical Trial Application (CTA) submissions. These pivotal studies generate the foundational exposure and safety data needed for clinical trial approval.<\/p>\n

Our GLP-certified laboratories deliver fully validated bioanalytical methods alongside comprehensive non-compartmental and compartmental PK\/TK analysis using Phoenix WinNonlin. Data are prepared to meet both FDA and EMA expectations, ensuring consistency, traceability, and acceptance across regions.<\/p>\n

These data are critical for both IND submissions in the US and CTA submissions in the EU, supporting regulatory review and approval.<\/p>\n

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End-to-End Bioanalytical Support for Diverse Modalities<\/strong><\/span><\/h4>\n

Our bioanalytical services are designed to accommodate the complexity and diversity of modern therapeutics. With extensive experience in method development and GLP validation, we support a broad range of matrices, including plasma, serum, and tissues as well as molecule types such as:<\/p>\n