Clinical Pharmacology Explained for Pharmaceutical Certification Students

While pharmacy is the science of the development, preparation, and distribution of drugs, clinical pharmacology focuses on exploring the relationship between drugs and the humans they’re prescribed to. As a subset of biomedical science, clinical pharmacology is underpinned by the application of pharmacological methods and principles to explore how drugs directly affect populations. The discipline of clinical pharmacology connects science with the practice of medicine, ensuring that those receiving drugs are effectively treated and that potential side effects are reduced.

If you’re exploring a career in Pharmaceutical Quality Assurance and Quality Control, you’ll be working to ensure that pharmaceutical drugs are both useful and safe. Within this role, the application of clinical pharmacology principles is important in ensuring that a medication is safely developed and regulated. 

Read on to discover more about clinical pharmacology and its importance within the pharmaceutical industry.

A Brief History of Clinical Pharmacology for Pharmaceutical Certification Students

Clinical pharmacology began as a general practice of trial and error in observing the effects of treatments and remedies on humans. While clinical pharmacology was originally confined to observing the body’s biological responses to drugs without attempting to understand the mechanisms behind them, the concept of clinical pharmacology became officially recognized in the 19th century. In 1847, Rudolf Buchheim was appointed as the first professor of pharmacology at Estonia’s University of Dorpat. Buchheim is responsible for taking the empirical study of drugs a step further, turning it into an experimental science.

Clinical pharmacology is a discipline that explores how drugs and humans interact

Today, pharmacology is a well-explored field of study, attempting to:

  • Analyze drugs for their desired activities
  • Determine a drug’s mode of action
  • Quantify drug activity

If you’re getting your pharmaceutical certification, it’s important to understand the role that clinical pharmacology plays in the development of pharmaceutical drugs. Clinical pharmacology utilizes the principles of pharmacology to determine how a drug interacts with patients. Clinical pharmacologists work to ensure the drug’s safety and effectiveness in order to provide patients with the highest level of care. 

The Principles of Clinical Pharmacology

Clinical pharmacology utilizes several different approaches to fully understand how a drug behaves as a treatment. These topics include, but are not limited to:

  • Pharmacokinetics 
  • Pharmacodynamics 
  • Pharmacogenetics 

Clinical pharmacology includes several methods of study to determine how a drug will affect humans

Pharmacokinetics is the study of how an organism (or a human) affects a drug. On the other hand, pharmacodynamics is the study of how the drug affects the organism. In pharmacokinetics, the chemical metabolism of a drug within the body is analyzed, beginning from when it’s administered up until it’s expelled from the body. 

Pharmacodynamics takes into account the concentration of a drug, determining the proper dosage needed for the drug to effectively bind to the receptor and produce the desired effect. 

Pharmacogenetics is the study of how different gene variations can determine the probability of a positive or negative reaction to a drug. Pharmacogenetics is related to the field of pharmacogenomics, in which the development of a drug is based upon gene variations. Together, pharmacokinetics, pharmacodynamics, and pharmacogenetics have an influence on how a drug is prescribed. They also influence the benefits of a drug’s treatment and its side effects. 

Pharmacokinetics, pharmacodynamics, and pharmacogenetics work together to influence how a drug is prescribed

Clinical Pharmacology and Pharmaceutical Quality Control and Assurance: How are they Related?

Quality assurance and quality control are important components of the safe and ethical development of a medication in any pharmaceutical laboratory. Graduates of pharmaceutical certification programs may work to ensure that pharmaceutical products are fit for their intended use before leaving the laboratory. These professionals use various measures to verify a product’s quality throughout the stages of its development, from manufacturing to distribution and storage. 

Within Clinical Pharmacology laboratories, quality assurance and control professionals are responsible for monitoring and evaluating the ability of clinical pharmacologists to develop treatments and study their effects on humans in a safe and effective manner. While complying with industry regulations, quality control and quality assurance associates may test production batches prior to their release using chemical and physical techniques. When equipped with an understanding of Clinical Pharmacology, these professionals work to reassure the public that a drug is safe to be prescribed.

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