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Related Concept Videos

FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

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Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
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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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PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure...
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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.
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The advent of drug therapy has profoundly shaped modern mental health care, providing targeted treatments for a range of psychological disorders. Psychotherapeutic drugs, classified into antianxiety, antidepressant, and antipsychotic medications, address symptoms across anxiety disorders, mood disorders, and schizophrenia. While these medications have transformed patient outcomes, they require careful management due to their potential side effects and limitations.
Antianxiety Medications
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Therapeutic Drug Monitoring: Overview and Classification01:16

Therapeutic Drug Monitoring: Overview and Classification

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Therapeutic Drug Monitoring (TDM) is a clinical practice that measures specific drug levels in a patient's blood at designated intervals to ensure the drug concentration stays within a therapeutic range. This monitoring is crucial for optimizing individual dosage regimens, enhancing therapeutic efficacy, and minimizing drug-related toxicity. TDM is vital for drugs with narrow therapeutic windows, significant variability in pharmacokinetics, and a clear correlation between plasma levels and...
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A Novel Approach for the Administration of Medications and Fluids in Emergency Scenarios and Settings
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More New Medication Approvals.

Beatrice B Turkoski1

  • 1Beatrice B. Turkoski, PhD, RN, Professor Emeritus, Kent State University College of Nursing, Milwaukee, WI.

Orthopedic Nursing
|July 22, 2016
PubMed
Summary

The Federal Drug Administration (FDA) approved new medications in early 2016. Nurses informed about these drug approvals can improve patient education and medication safety.

Area of Science:

  • Pharmacology
  • Drug Development
  • Patient Safety

Background:

  • The Federal Drug Administration (FDA) continually approves new medications.
  • Staying updated on these approvals is crucial for healthcare professionals.
  • Previous discussions covered early 2016 approvals.

Purpose of the Study:

  • To review selected new FDA drug approvals through January 2016.
  • To inform nurses about recent pharmaceutical advancements.
  • To enhance nurses' capacity to support patient understanding and prevent medication errors.

Main Methods:

  • Review of FDA drug approval data up to January 2016.
  • Selection of relevant new drug approvals for discussion.
  • Synthesis of information pertinent to nursing practice.

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Main Results:

  • Identification and summary of key new drug approvals.
  • Highlighting drugs with significant therapeutic implications.
  • Information presented is relevant for clinical practice.

Conclusions:

  • Knowledge of new FDA-approved drugs empowers nurses.
  • Informed nurses can better address patient queries and concerns.
  • Enhanced understanding can reduce medication misadventures and improve patient outcomes.