CLNR 338 – Scientific Literature Seminar
Credit: 2 hours
This interactive class introduces students to literature searching and critical analysis techniques. Skills in critical analysis of the scientific literature will be developed in small group discussion of scientific papers chosen by the faculty and students. These skills are applied in the form of written and oral presentations of projects developed by researching the current clinical research literature. In addition to learning how to apply these skills with a team, complete comprehension of these skills are applied in the form of oral presentations.
CLNR 340 – Regulatory Affairs
Credit: 2 hours
This course provides students with an overview of regulatory affairs within the pharmaceutical sciences and clinical research industries, with emphasis on requirements for initiating trials, developing pharmaceutical products, and gaining approval for worldwide marketing applications. Topics include data submission requirements, quality procedure regulations, Good Manufacturing Practices, Good Clinical Practices, and marketing considerations. Practical exercises simulate tasks representative by the entry level regulatory affairs positions within pharmaceutical companies, contract research organizations, and regulatory agencies.
CLNR 341 – Medical Terminology (Online)
Credit: 2 hours
This course is designed to introduce students to the language of the clinical research and medical communities. Instruction will engage students and provide them an opportunity to learn, understand, and apply the terminology in context of clinical research and medical settings.
CLNR 345 – Clinical Study Operations
Credit: 2 hours
This course will provide students with an overview of clinical study operations, including but not limited to site selection & evaluation, trial management, and clinical trial management systems, Trial Master File, recruitment, audits, reporting, and financial negotiations. The knowledge and skills obtained within the course will prepare students for entry-level positions for clinical study operations.
Prerequisite(s): PHSC 290
CLNR 425 – Medical Ethics in Clinical Research
Credit: 2 hours
This course provides a review of past medical and research historical events that have shaped the ethical standards in clinical research. Students in this course will analyze and discuss recent medical ethics cases on special topics including current events as appropriate.
CLNR 442 – Interpersonal Skills & Critical Thinking
Credit: 2 hours
Interpersonal skills are soft skills that one uses every day to interact with and relate to other people. Those with strong interpersonal skills are usually more successful in both their professional and personal lives. Critical thinking brings conscious awareness, skills, and standards to the process of observing, analyzing, reasoning, evaluating, reading, and communicating. This course will teach students how to develop interpersonal skills and become effective at listening, communicating, and working within a team. Additionally, students will learn how to write a professional resume and cover letter, as well as how to prepare for future interviews. This course will also teach the application of the principles of critical thinking.
CLNR 450 – Data Management
Credit: 2 hours
This course introduces the principles and practices of data management within pharmaceutical sciences and clinical research. Students will examine the lifecycle of clinical data, including collection, entry, validation, cleaning, coding, and archiving. Emphasis is placed on regulatory requirements for data integrity, electronic data capture systems, and the role of data management in supporting the quality and compliance of clinical trials. Students will apply industry standard practices to ensure data are accurate, complete, and audit ready throughout the research process.
Prerequisite(s): PHSC 290, CLNR 340
CLNR 455 – Managing & Monitoring Clinical Trials
Credit: 2 hours
This course provides both a theoretical and practical overview of the principles of managing and monitoring clinical trials. The focus will be on the role of the Clinical Research Associate (CRA) and Central Monitoring Associate, which will include activities centered on alternative monitoring strategies currently in use. Discussion topics will consist of reduced source document verification (SDV), remote monitoring, central monitoring, risk-based monitoring, triggered/ target monitoring, and site-based monitoring of clinical trials.
Prerequisite(s): CLNR 345
PHSC 290 – Principles of Pharmaceutical Sciences & Clinical Research
Credit: 1.0 hour
As the introductory gateway course for the Bachelor of Science in Pharmaceutical Sciences and Clinical Research (BSPSCR) degree program, this course provides students with a foundational overview of the complete drug development continuum, from laboratory-based drug discovery and formulation through clinical trial execution, regulatory review, and manufacturing. Students will examine how disciplines such as basic research, pharmacology, toxicology, and clinical research integrate within the lifecycle of medical products. This broad orientation prepares students for advanced coursework in the program and early exposure to career pathways in the pharmaceutical and clinical research industries.
PHSC 321 – Analytical Theory
Credit: 2 hours
This comprehensive course introduces laboratory skills needed to accurately and precisely measure the mass of solid and liquid samples and the volume of liquid samples. The concepts of concentration, dilution and stoichiometry are reviewed including their use in analysis. The acid base theory and the use of buffers will be discussed. Students will engage in the theory and operation of scientific spectroscopic instrumentation typically found in pharmaceutical, chemical, and biotechnical research and analytical facilities. The following spectroscopic techniques will be covered; ultraviolet/visible, atomic absorption/emission, infrared, and fluorescence spectrophotometry and Raman.
Prerequisite(s) Two (2) Semesters of General Chemistry; Co-requisite: PHSC 322/322L
PHSC 322/322L – Analytical Theory Pre-Lab/Lab
Credit: 1 hour
This comprehensive laboratory course introduces students to the need for laboratory skills to be accurate and precise as they create solutions of known concentration and make dilutions. The students will create buffers and perform acid base titrations. Students will operate UV and AES spectroscopic instrumentation typically found in pharmaceutical, chemical, and biotechnical research and analytical facilities
Co-requisite: PHSC 321
PHSC 323 – Chemistry of Drug Action
Credit: 3 hours
A comprehensive course in biochemistry which presents protein, lipid and nucleic acid biosynthesis and catabolism. Principles of enzyme kinetics, regulation, energy metabolism, signal transduction and macromolecular structure-function relationships are presented. It is recommended that a student take Microbiology or Cell Biology before taking this course.
Prerequisite(s): Biology (Cell or Micro) and Organic Chemistry I-II
PHSC 326 – Molecular Biology and Bioreactors
Credit: 3 hours
Molecular biology: a practical approach. This course is intended to provide the students with an understanding of the tools and techniques used in molecular biology, especially as they apply to the research and pharmaceutical application of modern recombinant DNA technology. This course provides an introduction to the basic concepts of recombinant DNA technology, such as cloning of genes from DNA libraries; use of various organisms for expression of gene products; analysis of DNA; and enzymatic modifications of DNA. Bioreactors (isolation, purification, and modification) of compounds or bio-products for analysis, use of large-scale cell culture for pharmaceutical production, and theoretical considerations for purification of cell-produced pharmaceuticals.
Prerequisite(s): PHSC 323 (C or better); Co- requisite PHSC 327/327L
PHSC 327/327L – Molecular Biology and Bioreactors Prelab/ Lab
Credit: 1 hour
Molecular biology: a practical approach. This course is intended to provide the students with an understanding of the tools and techniques used in molecular biology, especially as they apply to the research and pharmaceutical application of modern recombinant DNA technology. This course provides an introduction to the basic concepts of recombinant DNA technology, such as cloning of genes from DNA libraries; use of various organisms for expression of gene products; analysis of DNA; and enzymatic modifications of DNA. The course will emphasize analysis of pharmaceutical compounds as well as the production and purification of biopharmaceuticals.
Co-requisite PHSC 326
PHSC 328 – Introduction to Pharmacology
Credit: 3 hours
This course provides a comprehensive exploration of the mechanisms of drug action, focusing on how drugs interact with biological systems at the molecular, cellular, and organ levels. Emphasis is placed on understanding the fundamental principles governing drug-receptor interactions, signal transduction pathways, and the downstream biological responses that mediate therapeutic and adverse effects. The course examines how structural and physicochemical properties of drugs influence their activity, selectivity, and potency. Concepts of pharmacodynamics and pharmacokinetics are introduced as they relate to understanding drug mechanisms, including receptor theory, dose-response relationships, and the influence of absorption, distribution, metabolism, and elimination on drug activity. The course surveys all major classes of drugs, with a focus on elucidating their mechanisms of action within relevant physiological and pathological contexts.
Prerequisite(s): BIOL 285/L, CHEM 227/227L, CHEM 228/228L.
PHSC 335 – Project Management
Credit: 2 hours
This course introduces the foundational concepts of professional project management applicable across a range of industries. Students will examine the full project life cycle, including initiation, planning, execution, monitoring, and closeout. The role of the project manager in developing and maintaining a project’s timeline, budget, and quality standards will be explored. Students will learn how project management principles apply specifically to clinical research, including the coordination of individual clinical trials. The course also provides a broader perspective on managing new drug development projects within the pharmaceutical industry, where the project manager integrates areas such as basic research, pharmacology, toxicology, chemical development, analytical development, pharmacokinetics, metabolism, clinical research, and marketing to advance a product toward delivery.
Prerequisite(s): PHSC 290
PHSC 338 – Product & Process Validation
Credit: 2 hours
This course introduces students to the principles of current good manufacturing practices (cGMP), quality control, qualification and validation. The basics of regulatory compliance, the global nature of regulations and the importance of validation in the Pharmaceutical and Biotechnology Industries are discussed. Students learn about the qualification and validation of facilities, equipment, utilities, cleaning procedures, computer systems, test methods assays, and processes. The course also illustrates the importance of the team approach to validation and the need for thorough documentation of all associated activities.
PHSC 418 – Formulation & USP Testing
Credit: 2 hours
This is a comprehensive introductory course that provides students with the theory of common pharmaceutical dosage forms, pre- formulation and formulation design, with selected concepts in pharmaceutics. The students will learn how to follow guidelines for analysis of various chemicals and dosage forms in the US Pharmacopeia. The students gain knowledge of chromatographic instrumentation (GC/HPLC) which are typically found in pharmaceutical, chemical, and biotechnical research and analytical facilities.
Prerequisite(s): PHSC 321 (C or better); Co- requisite PHSC 419/419L
PHSC 419/419L – Formulation & USP Drug Testing Pre-lab/Lab
Credit: 1 hour
This is a comprehensive laboratory course that provides students with the preparation of common pharmaceutical dosage forms in current Good Manufacturing Practices (cGMP- like) environment. The students will follow guidelines for analysis of various chemicals and dosage forms in the US Pharmacopeia. The students gain use and application of chromatographic instrumentation (HPLC) found in pharmaceutical, chemical, and biotechnical research and analytical facilities.
Co-requisite PHSC 418
PHSC 451 – Scientific & Technical Writing
Credit: 2 hours
Scientific and Technical Writing is a required course for Pharmaceutical Sciences majors and is designed to enable students to effectively and accurately write and review a variety of technical documents used in pharmaceutical-related industries.
Prerequisite(s): ENGL 101 and 102
PHSC 490 – Senior Experiential Capstone
Credit: 12.0 Hours
PHSC 490 Senior Experiential Capstone provides practical experience in the pharmaceutical, chemical, biotechnology, and clinical research industries. Students and participating industries are matched to provide comprehensive work experience. Students present an overview of the companies in which they worked and provide a synopsis of their roles/experiences in the organizations during their internship.
Prerequisite(s): Passing all BSPSCR (PHSC/ CLNR) coursework with a D or higher; having a GPA of 2.00 for overall and major.