Mar 28, 2024  
2020-2021 Catalog 
    
2020-2021 Catalog [ARCHIVED CATALOG]

Drug, Discovery and Development Certificate


The drug development process consists of five steps: discovery, investigational new drug (IND) enabling studies, clinical research, FDA drug review, and FDA post-market drug safety monitoring. Drug discovery is the phase by which new candidate medications are identified. Modern drug discovery involves the validation of new therapeutic targets, identification of screening hits or other leads, medicinal chemistry and optimization of those hits to increase the affinityselectivity (to reduce the potential of side effects), efficacy/potency, chemical and metabolic stability (to increase the half-life), solubility, permeability, tissue distribution, and often oral bioavailability. Drug development is the phase of bringing a new pharmaceutical drug to the market once a clinical candidate compound has been identified through the phase of drug discovery. It includes preclinical research on microorganisms or animals, synthesis of drug product according to good manufacturing practice (GMP) standards, filing for regulatory status, such as via the US FDA for an  IND application to initiate clinical trials in humans, and may include the steps of obtaining regulatory approval with a new drug application (NDA) to market the drug.

This Graduate Certificate in Drug Discovery & Development (DDD) is a graduate program with four courses (total 12 semester credit hours) offered by the UNT System College of Pharmacy (SCP). It is designed for Doctor of Pharmacy (PharmD) students, other full-time students, and part-time students, including working professionals seeking to gain a systematic understanding of how drugs and medicines are discovered and developed, and to increase student’s understanding of clinical, medical, and regulatory affairs of the DDD process. This graduate certificate program will enhance the career options or promote the career advancement of students who complete this program. The program is delivered fully online, with the exception that SCP PharmD students take PHAR 7322 in person as it is a required course in the pharmacy curriculum. This certificate program can be completed within one to two years, depending on individual student’s schedule and engagement level.