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Bioanalytical Testing Services: Key to Streamlining Drug Development

gauri kanale

Drug development is a complex process that requires validating the safety, quality and efficacy of new drugs. To ensure positive outcomes, testing must be done at each stage of development according to stringent industry standards and regulations. This is where bioanalytical testing services play a pivotal role by providing reliable data to support various regulatory filings.

What are Bioanalytical Testing Services?

Bioanalytical testing refers to quantitative and qualitative analysis done on biological samples like blood, urine, tissues etc. to study the presence, concentration and breakdown of drugs, drug metabolites, biomarkers and other molecules.

Bioanalytical Testing Services encompass a range of specialized assays and tests conducted by certified clinical research organizations (CROs) and testing laboratories. Some key types include:

- Pharmacokinetic (PK) Testing

PK testing determines how the body affects a particular drug - how it is absorbed, distributed, metabolized and excreted. It is essential for evaluating drug absorption, metabolism, interactions and dosage optimization.

- Bioavailability and Bioequivalence Testing

These tests establish if a drug behaves in the same manner as its reference listed drug in terms of rate and extent of absorption. It is required for approval of generic drug applications.

- Immunogenicity Testing

This determines the immune response generated by biotherapeutics in the human body. It is important for assessing safety of biologics.

- Biomarker Testing

Biomarker analysis identifies and measures biomarkers in biological samples to gain insights into disease mechanisms and drug response variability.

- Method Validation Testing

Method validation establishes that the analytical procedure used is suitable for its intended purpose by confirming accuracy, precision, selectivity, linearity, range and robustness.

Benefits of Outsourcing Bioanalytical Testing

Considering rising costs and complexity of drug development, most pharmaceutical companies outsource their bioanalytical requirements to specialized service providers. Here are some key advantages:

- Expertise and Experience

CRO bioanalytical labs have seasoned scientists, state-of-the-art infrastructure and proven expertise across various therapeutic areas and analytical technologies.

- Quality and Compliance

CROs adhere to strict global quality standards and regulatory guidelines like GLP, GCP, cGMP. They are regularly audited to ensure high quality data generation.

- Cost Savings

Outsourcing eliminates need for in-house set up and maintenance of complex equipment and specialized human resources, significantly reducing costs.

- Flexibility and Scale

CROs can handle small batches as well as large volumes of samples as per client timelines. Their resources are scalable based on project requirements.

- Data Integrity

Sophisticated LIMS systems and stringent SOPs at CROs ensure data is captured, processed and reported accurately as per protocols.

- Regulatory Expertise

CRO regulatory experts assist with compilation and submission of various bioanalytical sections of CTA/IND/NDA/ANDA applications to global health authorities.

Key Considerations When Selecting a CRO

With the bioanalytical testing market growing at an annual rate of 7-10%, there are many service providers to choose from. However, certain factors must be evaluated to ensure right partner selection:

- Experience in Therapeutic Area

Check track record of successfully handling similar projects in past. Specialization adds value.

- Global Presence and Accreditations

Ability to support multinational trials. Preferably GLP certified and inspected periodically.

- Assay Technologies

Assess expertise and portfolio of validated bioanalytical methods like LC-MS/MS, immunoassays etc.

- Project Management Skills

Evaluate customer feedback, success rate of completing projects on time and budget.

- Pricing Models

Compare fully inclusive costs factoring regulatory support, equipment usage and SOP templates.

- Data Integrity Processes

Inspect systems for sample handling, result processing and archival as per regulatory norms.

With quality and timelines assuming utmost importance in drug development, outsourcing bioanalytical testing to a competent partner can significantly accelerate clinical trials and new product approvals. A diligent selection process focusing on technical expertise as well as compliance can potentially solve multiple challenges for sponsors.


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