Common Questions.
Find answers to commonly asked questions about drug development, bioanalysis and analytical sciences.
What is bioanalysis?
Bioanalysis is the scientific discipline that measures drugs, metabolites, and biomarkers in biological samples, ensuring accurate and reliable data for drug development and clinical trials.
What is bioanalysis, and why is it critical in drug development?
Bioanalysis involves the quantification of drugs, metabolites, and biomarkers in biological matrices (e.g., plasma, serum, tissue) using validated analytical methods. It is essential for pharmacokinetic (PK), pharmacodynamic (PD), and toxicokinetic (TK) studies, supporting regulatory submissions and clinical trial decisions.
What is analytical sciences?
Analytical sciences focus on the detection, identification, and quantification of substances in pharmaceutical and biological samples, ensuring drug quality, stability, and compliance with regulatory standards.
What is a Contract Research Organization (CRO)?
A Contract Research Organization (CRO) provides outsourced research services to pharmaceutical and biotech companies, supporting drug development, preclinical testing, clinical trials, and regulatory compliance.
What role does bioanalysis play in drug development?
Bioanalysis supports drug development by providing critical data on drug concentration, metabolism, and clearance, enabling informed decisions on safety, efficacy, and dosing strategies.
What are the different phases of drug development?
- Drug Discovery and Candidate Selection
- Preclinical (Nonclinical): Bioanalysis assesses PK/PD in animal models
- Clinical Development
- Phase I: First-in-human (FIH) studies determine safety and dosing
- Phase II: Evaluates efficacy and side effects in both healthy and patient populations.
- Phase III: Confirms effectiveness and safety in large patient populations.
- Market Approval
- Phase IV: Post-marketing surveillance and long-term safety monitoring as required by health agencies.
Bioanalysis plays a role at every stage, from early PK assessments to post-marketing drug monitoring.
What is method development and validation?
Method development optimizes bioanalytical techniques to ensure accuracy and sensitivity, while validation confirms reproducibility and compliance with regulatory guidelines such as FDA, EMA, and ICH.
What are GLP and GCP, and why are they important?
Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) are regulatory frameworks ensuring the reliability, integrity, and ethical conduct of nonclinical and clinical studies. Compliance with these standards is essential for regulatory approval.
What is LC-MS/MS, and why is it important?
LC-MS/MS (Liquid Chromatography-Tandem Mass Spectrometry) is a highly sensitive and specific analytical technique used for quantifying small molecules, peptides, and metabolites in biological samples. It is widely used in pharmacokinetic and bioequivalence studies. .
What is LBA, and how does it differ from LC-MS/MS?
Ligand Binding Assays (LBA) use antigen-antibody interactions to detect and quantify biomolecules such as proteins, antibodies, and cytokines. LBA is commonly used for large molecule bioanalysis, while LC-MS/MS is preferred for small molecules.
What is immunogenicity testing, and why is it necessary?
Immunogenicity testing evaluates the immune response to biologic drugs by detecting anti-drug antibodies (ADA) and neutralizing antibodies (NAb). This is crucial for assessing the safety and efficacy of monoclonal antibodies, gene therapies, and vaccines.
What is biomarker analysis, and how does Resolian support it?
Biomarker analysis helps measure disease progression, drug response, and patient stratification in clinical trials. Resolian offers both targeted and exploratory biomarker services using LC-MS, LBA, and multiplex immunoassays.
Learn about Resolian
Find answers to commonly asked questions about Resolian.
Who is Resolian?
Resolian is a leading global Contract Research Organization (CRO) providing specialized services in GxP and non-regulated bioanalysis, drug metabolism/pharmacokinetic (DMPK), and GMP CMC analytical and materials science. Its team of more than 500 experts across the US, UK, and Australia, Resolian supports pharma and biotech companies’ programs throughout the entire drug development continuum.
What does Resolian do?
Resolian is a global bioanalytical and analytical sciences partner specializing in drug development support, including preclinical and multi-regional clinical trial services.
Where are Resolian's locations?
Resolian operates globally, with laboratories and offices in the US, UK, China, and Australia.
What bioanalytical and analytical services does Resolian offer?
Resolian provides comprehensive bioanalytical (PK, PD, TK, and immunogenicity assessments), analytical chemistry (CMC, extractables & leachables, stability testing), and biomarker services for preclinical and clinical programs.
What types of studies does Resolian support?
We support nonclinical and clinical studies, including first-in-human (FIH) trials, bioequivalence (BE) studies, multi-regional clinical trials, and regulatory submissions for IND, NDA, and BLA applications.
What therapeutic areas does Resolian specialize in?
Resolian works across multiple therapeutic areas, including oncology, immunology, rare diseases, neurology, and infectious diseases, supporting both small molecules and biologics.
What regulatory agencies does Resolian work with?
Resolian complies with global regulatory agencies, including the FDA, EMA, MHRA, NMPA, and TGA, ensuring our studies meet international standards.
How does Resolian ensure data integrity and compliance?
We follow strict GLP/GCP guidelines, utilize validated analytical methods, and implement rigorous quality control measures to ensure data accuracy and regulatory compliance.
