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Related Concept Videos

Pharmacokinetics: Drug–Drug Interactions01:25

Pharmacokinetics: Drug–Drug Interactions

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Drug interactions occur when the pharmacological effect of one drug is altered by another substance, either enhancing or diminishing its activity. The drug whose activity is altered is known as the object drug, and the substance causing the alteration is called the agent drug or the precipitant. The net effects of these interactions are mostly undesirable, leading to decreased effectiveness or increased adverse effects. In rare cases, interactions can be beneficial, such as the enhanced...
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Bioequivalence of Drugs: Drugs with Multiple Indications01:09

Bioequivalence of Drugs: Drugs with Multiple Indications

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The concept of therapeutic equivalence (TE) in drugs with multiple indications is complex. A generic drug may be therapeutically equivalent to a brand-name product for one specific indication, but this doesn't necessarily mean it's equivalent for all other indications. Evidence of TE in one patient group and bioequivalence shown in healthy volunteers can support—but not confirm—TE for other indications. However, definitive proof requires individual clinical studies for each...
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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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Factors Influencing Drug Absorption: Drug Dissolution01:27

Factors Influencing Drug Absorption: Drug Dissolution

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The pharmacokinetic journey of drugs from solid oral dosage forms into systemic circulation is multifaceted. It begins with disintegration, a prerequisite ensuring a solid dosage form's subdivision into minute particles. Dissolution occurs next as these granulated entities solubilize in gastrointestinal fluids. This solubilization is crucial for the succeeding stage, permeation, which describes the traversal of the drug across the intestinal membrane and its subsequent entry into the blood...
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Factors Affecting Protein-Drug Binding: Drug-Related Factors01:18

Factors Affecting Protein-Drug Binding: Drug-Related Factors

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Drug binding to proteins is a complex phenomenon influenced by various drug-related factors, each playing a significant role in the interaction between drugs and proteins within the body.
One crucial factor in drug-protein binding is the drug's lipophilicity or its affinity for fat. More lipophilic drugs tend to have higher binding extents. For example, highly lipophilic drugs like cloxacillin exhibit substantial protein binding, with as much as 95% of the drug binding to proteins. In...
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Pharmacokinetics: Drug–Food and Drug–Viral Interactions01:26

Pharmacokinetics: Drug–Food and Drug–Viral Interactions

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A drug interaction occurs when the concurrent use of another drug, food, or an external substance alters the pharmacological activity of a drug. This interaction can modify the action of the original drug, affecting its effectiveness and safety.Drug–food interactions are significant as they impact drug absorption, metabolism, and excretion. For example, grapefruit juice is a well-known disruptor of drug metabolism. It inhibits the cytochrome P450 3A4 enzyme, crucial for the metabolism of...
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Mapping Metabolism: Monitoring Lactate Dehydrogenase Activity Directly in Tissue
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Drugs in lactation.

Ruud H J Verstegen1, Shinya Ito1,2

  • 1Division of Clinical Pharmacology and Toxicology, Department of Paediatrics, The Hospital for Sick Children, Toronto, Ontario, Canada.

The Journal of Obstetrics and Gynaecology Research
|January 22, 2019
PubMed
Summary
This summary is machine-generated.

Most medications are safe during breastfeeding, but infant toxicity risks exist. Pharmacokinetic (PK) modeling aids in assessing neonatal drug exposure and balancing risks versus lactation benefits.

Keywords:
lactation/breastfeedingmedicationnewborn/infantpharmacokineticsrisk assessment

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Area of Science:

  • Pharmacology
  • Neonatal Medicine
  • Lactation Studies

Background:

  • Medications are excreted into breast milk, posing potential risks of infant toxicity.
  • Factors influencing drug excretion include drug properties, dosage, and maternal pharmacokinetics (PK).
  • Assessing neonatal drug exposure typically involves comparing infant doses via milk to therapeutic doses.

Purpose of the Study:

  • To review the challenges in conducting clinical PK studies in breastfeeding infants.
  • To highlight the role of advanced modeling techniques in assessing neonatal drug exposure.
  • To emphasize the importance of rational risk-benefit assessment for medications during lactation.

Main Methods:

  • Review of existing literature on medication transfer into breast milk.
  • Discussion of conventional clinical PK study limitations in breastfeeding populations.
  • Exploration of population PK analyses and physiologically-based PK modeling and simulation.

Main Results:

  • Clinical PK studies in breastfeeding infants are challenging.
  • Population PK analyses and physiologically-based PK modeling offer complementary approaches.
  • These methods aid in rational risk assessment for infant drug exposure.

Conclusions:

  • Medication use during breastfeeding requires careful risk-benefit evaluation.
  • Advanced PK modeling techniques are valuable tools for assessing infant safety.
  • Consulting experts is recommended when information is limited to ensure infant well-being and continued lactation benefits.