What is Pharmacology?

Pharmacology is a discipline of medicine that studies how medications interact with the systems and processes of living organisms, focusing on drug action mechanisms as well as therapeutic and other purposes.

What is Clinical Pharmacology?

Clinical pharmacology is defined as the discipline that teaches, conducts research, develops policy, provides information and advice on the actions and proper use of medicines in humans, and applies that knowledge in clinical practice. The science of drugs and their therapeutic use is called clinical pharmacology. Clinical pharmacology fills the gap between medicine and research in the lab. The major goal is to improve prescription safety by maximizing pharmacological effectiveness while minimizing negative effects. It is closely related to basic pharmacology.

History of Clinical Pharmacology

Clinical pharmacology has been studied for centuries by looking at the effects of herbal remedies and early pharmaceuticals on people. The first breakthrough came when scientists discovered insulin using clinical pharmacology. Clinical pharmacology has developed into a multidisciplinary area that has aided in the knowledge of pharmacological interactions, therapeutic efficacy, and human safety. The establishment of pharmacology as a laboratory-based discipline is credited to Rudolf Buchheim. In the 1930s, Harry Gold and Walter Modell in the United States laid the foundation for clinical pharmacology as we know it today. They developed the double-blind clinical trial design and the utilization of the effect of kinetics to determine digoxin's absolute bioavailability. Paul Martini released a paper called methodology of therapeutic investigation in 1932, which outlined his experience in evaluation of drugs and likely qualified him as the first clinical pharmacologist. Martini examined the use of placebos or inert treatment, control groups, rating scales, and the no-of-1 trial design, as well as the need to determine the sample size and establish control conditions before starting a trial. The term clinical pharmacology was introduced by Paul Martini.

The aims of clinical pharmacology

Clinical pharmacologist is concerned with both:

• Optimal use of existing medications.
• A scientific study of drugs in humans.

The latter area includes both evaluations of the safety and efficacy of currently available drugs and the development of new and improved pharmacotherapy; this is the main aim of clinical pharmacology.

Who is a clinical pharmacologist?

Clinical pharmacologists are physicians, pharmacists, and scientists who specialize in the development and research of new drugs. Clinical pharmacologists work in research, industry, and government, among other places. Their research includes the identification of biomarkers, pharmacokinetics, drug metabolism, and genetics in the laboratory. They develop and assess clinical trials in the office, formulate and execute drug use regulation standards, and examine drug usage on a local and worldwide scale. They work closely with patients in the clinical setting, participate in experimental investigations, and analyze adverse reactions and interactions.

Drug development

Drug development is the process of bringing a new pharmaceutical medicine to market. It includes pre-clinical research on microorganisms and animals. The entire process takes more than a decade, from concept to pre-clinical testing in the lab to clinical trial development, including phase I–IV trials, to an approved vaccine or drug.

What is a clinical trial?

A clinical trial is a randomized trial in humans that evaluates the safety and efficacy of a new drug. A clinical trial examines a new drug's safety and efficacy. It is a set of tests used in medical research and drug development to gather data on the safety and efficacy of human health initiatives. A clinical trial is a mainstay of bringing a new drug to the market. Before doing a clinical trial, investigators conduct a pre-clinical trial using human cell structure and animal models. If the pre-clinical study is successful, a clinical trial will be conducted to see how well the treatment works in humans. The clinical trial involved four phases; they are phase-I, phase-II, phase-III, and phase-IV.

Phase-I

Investigators spent several months in phase I of a clinical trial looking at the impact of the medicine on around 20 to 80 people who have no chronic health issues. Phase I aims to determine the maximum dose that humans can tolerate without experiencing major side effects. During this phase, researchers constantly monitor participants to observe how their bodies react to the drug. According to the food and drug administration (FDA), approximately 70% of drugs move to phase-II trials.

Phase-II

Several hundred people living with the condition that the new medication is meant to treat are enrolled in the second phase of a clinical trial. They're generally given the same dose as in the previous phase, which was found to be safe. Investigators keep track of participants for months or years to see how effective the medication is and to learn more about any potential side effects. According to food and drug administration (FDA) findings, only 33% of drugs are moved to phase-III trial.

Phase-III

In phase III clinical trials, up to 3,000 people with the illness that the new medication is supposed to cure. This stage of the trial can run for several years. The purpose of phase III is to compare the new medication's effectiveness to that of other drugs for the same disease or conditions. In this phase of the trial, investigators use a process called randomization. In this process, they select the people randomly and give new drugs, while others are given existing medicine. Phase III studies can be difficult to design and execute.

Phase-IV

After the food and drug administration (FDA) has approved a medicine, phase IV clinical trials start. Thousands of people are involved in this phase, which might extend for years. This phase allows researchers to learn more about the medication's long-term safety, effectiveness, and any additional advantages.

Methods of clinical pharmacology

To avoid some errors in clinical trials, the following methods are used:

• Cross-over design.
• Single-blind design.
• Double-blind design.

Cross-over design

A crossover design is a repeated measurements design in which each experimental unit (patient) receives different treatments at different times throughout the trial and crosses over from one treatment to the next. Patients are randomly assigned to one of two treatments in a parallel design and remain on that medication for the duration of the trial.

Single-blind design

The single-blind design is when the participants don't know if they are in the treatment group in the control group.

Double-blind design

In a double-blind study, neither the participant nor the person collecting the dependent variable data has any idea which group they are in. For certainly, at least one individual is informed, but this is not the data collector. The double-blind technique is valuable to reduce researcher bias.

Context and Applications

This topic is significant in the exams at graduate, and postgraduate levels, especially for

• Bachelors in Pharmacy
• Masters in Pharmacy

Practice problems

Question 1: The science which deals with drug and their action in the human body is called_________.

1. Pathology
2. Physiology
3. Pharmacology
4. Biotechnology

Answer: Option 3 is correct.

Explanation: Pharmacology is a branch of medicine, which deals with the study of drug and their action in living organisms. The two main disciplines of pharmacology are pharmacodynamics and pharmacokinetics. The study of a drug's effects on biological systems is described as pharmacodynamics, whereas the research of a drug's effects on biological systems is called pharmacokinetics.

Question 2: The substance produced by or derived from living organisms and they are used to kill bacteria or prevent their multiplication is called__________.

1. Antibodies
2. Antibiotics
3. Enzymes
4. Hormones

Answer: Option 2 is correct.

Explanation: Antibiotic is a medicine; it fights against bacteria. It is an important type of antibacterial agent. Antibiotic medication is usually used to prevent and treat infections.

Question 3: Application of the drug to the skin often by friction is called______.

1. Installation
2. Insertion
3. Inunction
4. Insufflation

Answer: Option 3 is correct.

Explanation: Inunction is the action of rubbing oil or ointment into the skin.

Question 4: Drugs used to relieve pain are_____.

1. Antibiotics
2. Antipyretics
3. Analgesics
4. Aspirin

Answer: Option 3 is correct.

Explanation: Analgesic or pain killer is a member of the group of drugs, is used to relieve the pain. Analgesics are typically classified based on their mechanism. These include paracetamol, opioid, etc.

Question 5: How many people are participating in phase-II of a clinical trial?

1. 10 to 15
2. 20 to 80
3. 50 to 100
4. 1000 to 5000

Answer: Option 3 is correct.

Explanation: In phase-II, several 100 participants living with the condition that the new medication is meant to treat are enrolled in the second phase of a clinical trial. They're generally given the same dose as in the previous phase, which was found to be safe.