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Related Concept Videos

Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

201
Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
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Bioavailability Study Design: Single Versus Multiple Dose Studies01:11

Bioavailability Study Design: Single Versus Multiple Dose Studies

318
Bioavailability studies are essential for understanding how a drug is absorbed, distributed, metabolized, and excreted in the body. These studies assess the extent and rate at which the active pharmaceutical agent becomes available at the site of action. The design of bioavailability studies can involve single-dose or multiple-dose regimens, each with distinct advantages and limitations.Single-dose studies are the preferred approach due to their simplicity and reduced drug exposure for...
318
Dosage Regimens: Designs and Approaches01:28

Dosage Regimens: Designs and Approaches

448
Designing a dosage regimen, which refers to the manner of drug administration, is a complex process involving the selection of drug dose, route, and frequency. This process is underpinned by pharmacokinetic parameters derived from tests and population averages. These parameters are then tailored to patient-specific variables such as diagnosis, demographics, and allergy status. Once therapy commences, therapeutic response monitoring is critical and achieved through clinical and physical...
448
Bioavailability Study Design: Absolute Versus Relative Bioavailability01:27

Bioavailability Study Design: Absolute Versus Relative Bioavailability

508
Bioavailability is a crucial pharmacokinetic parameter that quantifies the proportion of an administered drug that reaches the systemic circulation and is available for therapeutic action. Regulatory agencies mandate the assessment of bioavailability, typically measured as the area under the drug plasma concentration-versus-time curve (AUC), to ensure the efficacy and safety of pharmaceutical products. These evaluations are categorized as absolute and relative bioavailability studies.Absolute...
508
Drug Dosing: Obese Patients01:21

Drug Dosing: Obese Patients

332
In the United States, obesity is a prominent concern. It is linked to heightened mortality rates due to increased occurrences of conditions such as hypertension, atherosclerosis, coronary artery disease, and diabetes compared to nonobese individuals. A patient is classified as obese if their actual body weight surpasses the ideal or desirable body weight by 20%, based on Metropolitan Life Insurance Company data. Ideal body weights consider average weights and heights for males and females...
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Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

376
In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
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Related Experiment Video

Updated: Mar 20, 2026

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BReastfeeding Attitude and Volume Optimization (BRAVO) trial: study protocol for a randomized controlled trial.

Ary I Savitri1, Nikmah S Idris2,3, Wahyuni Indawati1,4

  • 1Julius Center for Health Sciences and Primary Care, Julius Global Health, University Medical Center Utrecht, Utrecht, The Netherlands.

Trials
|June 3, 2016
PubMed
Summary

The BRAVO trial investigates long-term breastfeeding benefits on chronic disease risks. This study empowers mothers to improve breastfeeding rates and infant health outcomes.

Keywords:
Arterial stiffnessBreastfeedingBreastfeeding empowermentBreastfeeding rateCarotid artery wall intima-media thickness (CIMT)Trial

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Area of Science:

  • Public Health
  • Pediatrics
  • Cardiology

Background:

  • Limited evidence exists on long-term breastfeeding benefits for chronic diseases.
  • Breastfeeding offers short-term protection against infections, allergies, and lung diseases.
  • The BReastfeeding Attitude and Volume Optimization (BRAVO) trial addresses this gap.

Purpose of the Study:

  • To assess the impact of breastfeeding on early indicators of cardiovascular, respiratory, and metabolic diseases.
  • To evaluate the effectiveness of breastfeeding empowerment interventions in promoting breastfeeding.
  • To examine long-term health outcomes in children based on breastfeeding practices.

Main Methods:

  • An ongoing randomized trial in Jakarta, Indonesia, involving 1,000 pregnant women.
  • Participants with low breastfeeding intention are randomized to an optimization program or usual care.
  • Primary outcomes include breastfeeding rates, lung function, blood pressure, and vascular/cardiac characteristics.

Main Results:

  • 80% of the planned participants (784 women) have been randomized.
  • 1-year follow-up data shows satisfactory completeness (90.1%).
  • Participants are primarily from lower socioeconomic backgrounds with blue-collar jobs.

Conclusions:

  • The BRAVO trial is actively recruiting and collecting data on breastfeeding's long-term health impacts.
  • Findings will inform strategies to promote breastfeeding and mitigate chronic disease risks.
  • The study focuses on vulnerable populations to understand breastfeeding's role in lifelong health.