Enhancing Your Probability of Success
Delphi Quantitative Sciences specializes in pharmacometrics and clinical pharmacology services. We offer solutions from preclinical-to-clinical translation, dose selection, and drug candidate differentiation through our state-of-the-art modeling methodologies. We pride ourselves in transforming complex data into intuitive insights that help drug development teams take specific actions to enhance their probability of success. In addition, we provide clinical pharmacology services that include pharmacokinetic (PK), pharmacodynamic (PD), toxicokinetic (TK), and noncompartmental (NCA) analyses. New to our capability is report and regulatory writing, particularly in the clinical pharmacology and nonclinical pharmacology and toxicology areas. Learn more about our services above.
Pharmacometrics
Pharmacometrics is a field of study that uses modeling and simulation to quantify the relationship between the administered drug and its interaction with the body's response. Mathematical and statistical methods are utilized to develop models which are often constructed based on the underlying pharmacology, physiology or disease. Pharmacometric analyses have become common in the pharmaceutical industry as they are important for decision making in drug development, regulatory expectations and drug product labeling.
Clinical Pharmacology
Clinical Pharmacology (CP) promotes the rational use of medications in humans by studying their restorative effect to amplify the drugs effect and reduce the side effects. CP bridges the gap between science and the practice of medicine through innovative research, development and regulation of medications. We can guide your program from candidate selection through NDA or BLA and even through post-marketing activities. We can help inform decisions from FIH to Phase 1a/b, Phase 2a/b POM, POC, and designing pivotal Phase 3 study.
Regulatory Writing
We have experience authoring a variety of regulatory documents across a wide range of therapeutic areas. We have authored many clinical study reports (CSRs), clinical protocols, Investigator Brochures, and components of Investigational New Drug (IND) applications. We have also written portions of marketing applications.