Discover the essential steps in preclinical drug development, including regulatory pathways, Good Laboratory Practices, and risk management strategies. Learn how BioBoston Consulting can assist your organization in ensuring compliance and patient safety.
What Is Preclinical Drug Development?
Preclinical drug development refers to a series of tests performed on a candidate compound in vitro and in vivo to determine its safety profile, pharmacokinetics activity as well as potential to treat or serve the purpose for what it has been synthesized. Such investigations are critical to identify potential leads and refine their formulations before moving into human trials.
Regulatory oversight: Preclinical drug development is regulated by the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other national regulatory agencies. This agency has strict regulatory provisions to ensure safe and effective pharmaceutical products.
Preclinical drug development regulatory pathways: The whole preclinical pathway requires strict compliance with regulated norms. There are some crucial steps to do so:
Preclinical Development Plan: Prepare a comprehensive preclinical development plan delineating the goals, study design, endpoints and timelines. This plan must meet regulations and consider any risks and issues.
Regulatory Guidance: Get your regulatory questions answered before you submit to the regulators. Interacting with regulators prior to the development of an innovative technology can also help in defining the standards and approaches that work best, as well as expedite regulatory review.
Good Laboratory Practices (GLP): Perform non-GLP studies in line with GLP guidelines. Good Laboratory Practice (GLP) is a quality system statute for nonclinical laboratory studies that guarantee the uniformity, trustworthiness, durability, and closeness of records.
Safety Pharmacology Studies: Conduct safety pharmacology studies to gage the adverse effects of the new drug on critical physiological systems such as cardiovascular, respiratory and central nervous system.
Toxicology Studies: Perform the standard in-vivo toxicology studies to understand the drug being developed is safe. Acute and chronic toxicity, genotoxicity, carcinogenicity as well as reproductive toxicity are covered by these studies.
Pharmacokinetic and Pharmacodynamic Studies: Perform pharmacokinetic (PK) and pharmacodynamic (PD) studies to assess the drug candidate’s absorption, distribution, metabolism, excretion (ADME) and toxicity profile as well as its principal effects.
Rationale: Formulation Optimization Efforts primarily focus on improving stability, bioavailability, and therapeutic efficacy of the drug candidate. The route of administration, dosage form and compatibility with excipients are important parameters to be kept in mind during these formulation studies.
Regulatory Submissions: Draft and submit regulatory dossiers comprising preclinical data, study reports, and other supportive documentation to regulatory agencies for validation and approval. Verify that submissions are complete and accurate and meet regulatory requirements.
Have open communication with regulatory agencies on the preclinical development. Respond promptly and openly to any issues or questions that come up as a result of regulatory reviewers.
Risk Management: Develop and implement risk management strategies to address potential risks associated with preclinical development. Catch safety issues early to save delays in weeks or months of your development cycle.
Conclusion
Pharmaceuticals can adopt a process-oriented and regulatory compliant path to ensure that all the drug leads are well tested, effective and safe for consumption. Understanding and navigating these processes requires early engagement with regulatory agencies, careful planning and open communication. Stakeholders who prioritize regulatory compliance and keep their promise to patients will efficiently and confidently navigate the arduous preclinical development phase.
Contact BioBoston Consulting or visit our website to discover how we can assist your organization today.
