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Drug Administration and Therapy Phases: Overview01:26

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Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
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Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
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Drugs are chemical substances that modify biological responses by interacting with macromolecular targets such as receptors, ion channels, transporters, and enzymes. Pharmacodynamics describes the course of action of drugs leading to the physiological effect at a specific site in the body.
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Off-Label Medication: From a Simple Concept to Complex Practical Aspects.

Carmen-Maria Rusz1, Bianca-Eugenia Ősz2, George Jîtcă2

  • 1Doctoral School of Medicine and Pharmacy, I.O.S.U.D., George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Târgu Mureș (UMPhST), 540142 Târgu Mureș, Romania.

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Off-label drug use, the unapproved application of approved medications, remains essential due to unmet clinical needs. Regulatory bodies are working to ensure safe practices and encourage research in this area.

Keywords:
clinicaloff-labelpracticeregulationsafety

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Area of Science:

  • Pharmacology
  • Drug Regulation
  • Clinical Practice

Background:

  • Off-label drug use involves prescribing approved medications for unapproved indications.
  • This practice is driven by unmet clinical needs, particularly in specialized therapeutic areas.
  • Despite its long history, off-label prescribing remains a complex and current issue.

Purpose of the Study:

  • To define the concept of off-label drug use.
  • To describe the regulation surrounding off-label prescribing.
  • To explore challenges and safety issues in specific therapeutic areas.

Main Methods:

  • Systematic literature research was conducted.
  • Keywords included "off-label", "prevalence", "rare diseases", "oncology", "psychiatry", "pediatrics", and "drug repurposing".

Main Results:

  • Off-label use is indispensable in current medical practice.
  • Complexities arise in therapeutic areas such as rare diseases, oncology, pediatrics, and psychiatry.
  • Safety issues associated with off-label use are a significant concern.

Conclusions:

  • Off-label drug use is a critical aspect of modern medicine, addressing unmet needs.
  • Regulatory agencies and governments are actively working to promote safe practices and further research.
  • Continued efforts are needed to balance clinical necessity with regulatory oversight.