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Related Concept Videos

Dosage Regimen: Fixed Dose01:01

Dosage Regimen: Fixed Dose

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Fixed-dose regimens are a common approach to administer drugs to achieve and maintain desired levels of the drug in the body. In this dosing strategy, a specific amount of medication is given at regular intervals, often multiple times a day, to ensure a consistent drug concentration in the bloodstream.
Fixed-dose regimens can be used for various routes of administration, including intravenous (IV) injections and oral medications. For IV administration, a predetermined amount of the drug is...
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Dosage Regimens: Designs and Approaches01:28

Dosage Regimens: Designs and Approaches

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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...
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Dosage Regimen: Individualization01:24

Dosage Regimen: Individualization

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Individualization in dosing regimens is the customization of medication doses for individual patients. Its necessity arises from the goal of maximizing therapeutic benefits while minimizing risks. This approach is pivotal because human responses to drugs can vary widely; what is effective for one person may be inadequate or excessive for another. Interpatient (intersubject) variability refers to differences in drug responses between individuals, while intrapatient (intrasubject) variability...
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Dosage Regimens: Partial Pharmacokinetic Parameters01:01

Dosage Regimens: Partial Pharmacokinetic Parameters

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It is not uncommon for complete drug pharmacokinetic profiles to remain elusive in pharmacokinetics. This necessitates certain educated assumptions by pharmacokineticists to determine appropriate dosage regimens without comprehensive pharmacokinetic data from animal or human studies. One prevalent assumption is setting the bioavailability factor, denoted as F, to 1 or 100%. This assumption caters to the scenario where a drug doesn't achieve full systemic absorption, resulting in the patient...
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Biopharmaceutical Factors Influencing Drug Product Design: Overview01:22

Biopharmaceutical Factors Influencing Drug Product Design: Overview

414
Rational drug product design integrates knowledge of the drug’s physicochemical properties, formulation components, manufacturing techniques, and intended route of administration. Each factor influences the drug’s performance, including how it is released, absorbed, and eliminated in the body.The physicochemical properties of a drug—such as solubility, stability, and particle size—affect its compatibility with excipients and the choice of dosage form. Excipients, though...
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Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

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Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
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A Regulatory and Formulation Perspective on Fixed-Dose Combinations (FDCs).

Manisha S Jain1, Ravi Kumar Reddy Juturi1, Prakash S Goudanavar1

  • 1Department of Pharmaceutics, Sri Adichunchanagiri College of Pharmacy, Adichunchanagiri University, B.G. Nagara, Mandya, Karnataka, 571418, India.

Recent Advances in Drug Delivery and Formulation
|March 21, 2026
PubMed
Summary
This summary is machine-generated.

Fixed-dose combinations (FDCs) improve patient adherence and therapeutic outcomes by combining multiple drugs into one. Despite formulation and manufacturing challenges, FDCs are vital for global health, requiring regulatory harmonization.

Keywords:
Combination productsbioavailabilitybioequivalence.manufacturing considerationsregulatory frameworks

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems
  • Regulatory Science

Background:

  • Fixed-dose combinations (FDCs) integrate multiple active pharmaceutical ingredients into a single dosage form.
  • FDCs enhance patient compliance, enable synergistic therapeutic effects, and address complex disease management.
  • Innovative formulation strategies are key to overcoming active ingredient incompatibilities and achieving diverse release profiles.

Purpose of the Study:

  • To review recent advancements in FDC formulation, manufacturing, and market trends.
  • To analyze and compare global regulatory frameworks (USFDA, EMA, CDSCO) for FDCs.
  • To evaluate clinical evidence and post-marketing data on FDC safety, efficacy, and practicality.

Main Methods:

  • Systematic literature review of FDC research and development.
  • Comparative analysis of regulatory guidelines and approval pathways.
  • Synthesis of clinical trial data and post-marketing surveillance reports.

Main Results:

  • Novel FDC dosage forms like co-crystals and liquid-filled capsules show improved outcomes and cost-effectiveness.
  • FDCs represent a significant portion of antibiotic usage in India, highlighting economic and clinical impact.
  • Regulatory pathways for FDCs vary globally, indicating a need for harmonization to facilitate international adoption.

Conclusions:

  • FDCs simplify medication regimens, boost adherence, and support the introduction of novel therapeutics.
  • Challenges include formulation stability, analytical quantification, manufacturing complexity, and monitoring adherence.
  • Strategic development, robust regulatory oversight, and international collaboration are crucial for maximizing FDC potential in healthcare.