Jan 22

Adverse events (Side effects)
Adverse events refers to any side-effect that occurs in a subject while under treatment (study drugs, study medical devices), or within a pre-specified period of time after completion of the treatment.

Clinical trial
Clinical trials evaluate the effectiveness and safety of investigational drugs or medical devices by monitoring their effects and efficacy on large groups of people.

Clinical trial centre
Centre or clinic where a clinical trial is taking place.

DNA (deoxyribonucleic acid)
DNA is the hereditary material in humans and almost all other organisms. The most important role of DNA is to store information on a long term basis. DNA can be compared to a set of blueprints, a recipe or a code, because it contains a set of directions that are needed to build components of the cell. While some parts of the DNA carry the genes, our genetic information, other parts DNA serve to regulate the use of the genetic information.

In clinical trials and pharmaceutics, the term drug is synonymous with investigational (medicinal)
product, medicinal product, medicine and pharmaceutical product (including vaccines and other biological products).

Drug affinity
The drug affinity measures the ability of the drug to bind to its molecular target.

Drug efficacy
The drug efficacy refers to the ability of a drug-receptor complex to produce a functional response. A drug with high efficacy is also called agonist, in opposition to an antagonist, that has little or no effect.

Drug safety
Drug safety has to be assessed before a drug can be marketed. Drug safety combines the results of animal testing and clinical trials, to evaluate its side effects.
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Drug response
Drug response includes the processes of drug absorption and disposition (e.g.,
pharmacokinetics, (PK), and drug effects (e.g. pharmacodynamics (PD), drug
efficacy and adverse event of drugs).

Ethics are the standards that determine the conduct of a person or the members of a profession .

Genomic biomarker
A genomic biomarker is a measurable change in DNA and/or RNA characteristic that suggest a normal biologic processes, a pathogenic (infective) processes, or a response to some form of therapy such as drug interventions is taking place. Genetic biomarkers can include, but are not limited to: expression/function/regulation of a gene, DNA modifications, DNA rearrangements, RNA expression levels, RNA processing.

Good clinical practice (GCP)
GCP is an international quality standard that can be used by governments to regulate any research involving human subjects.

Pharmacokinetics (PK)
PK are the study of processes by which a drug is absorbed, distributed, metabolized, and eliminated by the body.

Pharmacodynamics (PD)
PD are the study of biochemical and physiological effects of drugs on the body and the mechanisms of drug action and the relationship between drug concentration and effect.

Pharmacogenomics (PGx)
PGx is the study of variations of DNA and RNA characteristics and are related to drug responses. PGx are applicable to activities such as drug discovery, drug development, and clinical practice.

Pharmacogenetics (PGt)
PGt is a subset of pharmacogenomics (PGx) and is specific to the study of variations in DNA sequence as related to drug response. PGt are applicable to activities such as drug discovery, drug development, and clinical practice.

In a clinical trial setting, a placebo is an inactive substitution given to a subject to compare its effects with those of a real drug. It is suspected that placebo often offer psychological benefits when subjects believe that they are receiving a real treatment.

RNA (ribonucleic acid)
RNA are intermediates between DNA and the cells’ components. They allow the genetic information found in DNA to be built into proteins.

For more information, visit Clinical Trials Info.

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