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Related Concept Videos

Biopharmaceutical Factors Influencing Drug Product Design: Overview01:22

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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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Drug Products: Biologics, Biosimilars and Interchangeables01:28

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Body:Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
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In pharmaceutical development, it's crucial to establish a predictive in vitro–in vivo correlation (IVIVC) for two or more formulations to gain a comprehensive understanding of release properties. IVIVC reduces the need for costly in vivo studies and facilitates the establishment of meaningful dissolution specifications with significant cost savings and decreased regulatory burden. Furthermore, a meaningful IVIVC should predict Cmax and AUC within 20%, aligning with FDA guidance while...
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Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

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Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
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Dosage Regimen: Individualization01:24

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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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Biopharmaceutics and Pharmacokinetics: Overview01:28

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Understanding drugs, drug products, and their performance in pharmaceutical science is pivotal. Drugs, whether simple molecules or complex compounds, are designed to interact with the body's biological systems to diagnose, treat, or prevent diseases. Drug products include various delivery systems such as tablets, capsules, injections, and inhalers. The performance of these drug products is gauged by their ability to deliver the active ingredient to the desired site of action at the...
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Updated: Dec 24, 2025

Injectable Supramolecular Polymer-Nanoparticle Hydrogels for Cell and Drug Delivery Applications
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Injectable Combination Product Development: Facilitating Risk-Based Assessments for Efficiency and Patient Centric

Fran DeGrazio1, Diane Paskiet1

  • 1West Pharmaceutical Services, Inc, Exton, Pennsylvania 19341.

Journal of Pharmaceutical Sciences
|April 10, 2020
PubMed
Summary
This summary is machine-generated.

Navigating regulatory pathways for combination products (CPs) is crucial for novel injectable medicines. Early planning and stakeholder engagement streamline development, ensuring patient safety and faster market access.

Keywords:
DevelopabilityDrug delivery systemsInjectable(s)Injector(s)Quality by design (QbD)Regulatory science

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Area of Science:

  • Regulatory Science
  • Pharmaceutical Development
  • Medical Device Engineering

Background:

  • Combination products (CPs) are increasing due to novel drug innovation and demand for home self-administration.
  • Regulatory approval for CPs depends on the primary mode of action and jurisdiction.
  • Drug-device CPs often require collaborative reviews between different US Food and Drug Administration (FDA) Centers.

Purpose of the Study:

  • To outline strategies for early planning in injectable drug-device development.
  • To address challenges in aligning regulatory information for combined drug and device applications.
  • To facilitate timely market entry for patient-centric combination product solutions.

Main Methods:

  • Review of regulatory requirements for combination products.
  • Analysis of challenges in integrating drug master files and design history files.
  • Emphasis on early stakeholder engagement and cross-disciplinary collaboration.

Main Results:

  • Aligning policies from different government branches is necessary for a single application.
  • Integrating information for drug master files and design history files presents a challenge.
  • Patient risk management is a common objective for both drug and device components.

Conclusions:

  • Early planning and stakeholder engagement are advantageous for navigating complex regulatory landscapes.
  • Adopting principles of quality by design and design controls aids in risk mitigation.
  • Streamlined development processes can accelerate the delivery of innovative injectable combination products to patients.