Preclinical Research for Drug Development: Importance and Process
Bioanalysis is a critical upfront activity in drug development. Delays in the preclinical phases of development can derail an otherwise promising therapy. Having a CRO partner with the experience and resources to navigate the world of preclinical bioanalytics is key to streamlining and accelerating the path to clinical trials.
BioAgilytix offers comprehensive preclinical support through our pharmacokinetics (PK) and drug metabolism, immunogenicity, biomarker, and CMC bioanalytical services. We work scientist to scientist, collaborating with our clients to deliver integrated bioanalytical solutions for their toughest preclinical drug development needs.
We are able to quickly solve any problems that may arise during preclinical research through a cooperative partnership, pairing our advanced scientific expertise with dedicated project management processes to produce timely, high-quality results.
Proven experience in drug development and preclinical research
In vitro studies
A reliable CRO brings specialized expertise, state-of-the-art facilities, and access to advanced technologies, which significantly enhances the quality and efficiency of the research process. As recognized leaders in bioanalysis, BioAgilytix brings a wealth of experience in study design, execution, and data analysis to ensure accurate and reliable results for your in vitro program.
In vitro drug-drug interaction studies
One of the concerns of developing new pharmaceutical candidates is how the compound will interact with co-administered medications. These drug-drug interactions may result in different pharmacokinetic profiles and may lead to an adverse event or loss of efficacy for either the candidate or the marketed medicine. BioAgilytix offers a range of services to evaluate the potential for drug-drug interactions, including cytochrome P450 (CYP450) induction studies, UDP-glycosyltransferase (UGT) induction studies, CYP/UGT inhibition studies, CYP/UGT reaction phenotyping, and transporter substrate/inhibition studies. In vitro drug-drug interaction studies are performed in accordance with appropriate global industry and regulatory expectations.
Dose formulation analysis
Dose formulation analysis is an important part of any successful preclinical study program. We provide high quality, preclinical dose formulation analysis for both GLP and non-GLP studies, to ensure your study starts off on the right track.
Analysis of in vivo study samples
Once a drug candidate has been identified, in vivo preclinical studies are essential for evaluating the safety, efficacy, and pharmacokinetics of potential therapeutics before testing them in humans. These studies provide valuable data on the compound’s effects, mechanism of action, and dose optimization, bridging the gap between in vitro laboratory research and clinical trials. BioAgilytix provides sample testing for preclinical studies. Our scientists have extensive experience developing assays and working with samples from a variety of species including rodent, canine, primate, and minipig.
Pharmacokinetics
BioAgilytix performs compartmental (model-dependent) or noncompartmental (model-independent) pharmacokinetic analysis, using validated Phoenix WinNonlin software. We conduct PK simulations to predict the concentration profile of a drug under various input conditions. We also offer pharmacokinetic consulting, which includes assistance with PK study design, protocol development, and performing PK calculations for our clients.
Drug metabolism
Drug metabolism testing during the preclinical stage of drug development may include assessment of drug-drug interaction potential, metabolic stability, metabolite profiling, and protein binding. BioAgilytix offers industry-standard drug metabolism support for both large and small molecule therapeutics with stage-appropriate regulatory compliance for preclinical studies.
IND-enabling studies
The preclinical programs necessary for a successful IND application require significant amounts of time and resources. BioAgilytix has the expertise and bioanalytical capacity to provide testing for IND-enabling studies by delivering regulatory compliant pharmacokinetic, pharmacodynamic, biomarker, and immunogenicity data quickly. We understand the need for efficient analytical support when generating the preclinical data necessary to make the transition to first-in-human studies.
Toxicology
Toxicology studies are a critical aspect of in vivo testing during the preclinical stage. These studies are designed to fully evaluate the safety of a therapeutic by determining the relationship between the administered dose and any drug-related adverse effects. BioAgilytix routinely performs analysis of non-GLP and GLP toxicology study samples across a variety of endpoints. Our scientists have extensive expertise working with common toxicology animal species including but not limited to rodent, canine, nonhuman primate, and minipig.
Additional preclinical testing and product development services
Project discovery phase
BioAgilytix has a proven track record of supporting successful drug discovery programs. We offer a full range of discovery services including lead optimization, compound library screening, assay development and validation, and toxicology assessments.
Clinical drug development process
Once your compound moves from the preclinical to the clinical phase of development, it’s important to have a CRO partner with a deep understanding of the drug development process. Our expertise, regulatory track record, focus on quality, and continuity of scientific oversight allow us to make it right from the start.
CMC analytical development
BioAgilytix offers a full range of services to successfully see your product through CMC Bioanalytical development.
Research facilities for preclinical analysis
BioAgilytix has established a robust network of state-of-the-art facilities strategically located around the globe. This network allows us to offer localized support to clients worldwide, ensuring rapid turnaround times, seamless project management, and efficient communication. Learn more about our global locations:
Durham, NC, USA
Boston, MA, USA
San Diego, CA, USA
Hamburg, Germany
Melbourne, Australia
Brisbane, Australia
Frequently asked questions about the preclinical development of drugs for a clinical trial
The purpose of preclinical research is to investigate the safety and efficacy of new medical treatments, drugs, or therapies before they are tested on humans in clinical trials. Preclinical studies help researchers understand how a treatment candidate works, identify any potential side effects, determine appropriate dosages, and assess the feasibility of moving forward with human trials.
Preclinical testing involves in vitro and in vivo studies to evaluate the safety, efficacy, and mechanism of action of new treatments before human trials. It assesses toxicity, pharmacokinetics, and formulation development, informing decisions for advancing potential interventions to clinical testing.
Preclinical studies are conducted using in vitro (test tube or cell culture) and in vivo (animal) models to gather data on the potential benefits and risks of a particular intervention.