Describe the role of a Clinical Pharmacologist.
These professionals determine optimal dosages and administration methods by studying both pharmacokinetics and pharmacodynamics.
This FDA application & approval moves a drug from pre-clinical to phase I of clinical trials.
IND (Investigational New Drug)
Most clinical development medical directors have this type of advanced degree, often abbreviated as MD.
Medical Doctor degree
This three-letter acronym stands for the guidelines that Clinical Research professionals must follow when conducting trials.
GCP (Good Clinical Practice)
In your own words, describe pharmacokinetics.
This field of study focuses on how drugs move through the body over time, examining absorption, distribution, metabolism, and excretion.
These measurable substances in your body help researchers learn about health and can show if a new medicine is working.
Biomarkers
In your own words, describe the difference between a Clinical Development Medical Director and a Medical Affairs Medical Director.
Clinical development medical directors focus on pre-market clinical studies, while their counterparts in Medical Affairs focus on post-launch activities.
Clinical Sciences teams develop this document, abbreviated as TPP, which outlines desired characteristics of the final drug product.
Target Product Profile
In your own words, describe pharmacodynamics.
This branch of study examines how drugs impact the body and produce their therapeutic effects, focusing on biochemical interactions.
The Clinical Translational Development team bridges the gap between laboratory research and clinical trials, effectively translating scientific discoveries into potential therapies for this type of testing.
Human testing/phase I/clinical trials
Clinical development medical directors may be responsible for communicating trial progress and results to who?
Internal & external stakeholders
Clinical Sciences team members often interact with regulatory agencies, present findings to company leadership, and contribute to publications in these types of journals.
Scientific journals