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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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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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Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
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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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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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Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
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Design control considerations for biologic-device combination products.

Dave Anderson1, Roger Liu1, J Anand Subramony1

  • 1AstraZeneca/MedImmune, One MedImmune Way, Gaithersburg, MD 20878, United States.

Advanced Drug Delivery Reviews
|January 16, 2017
PubMed
Summary
This summary is machine-generated.

Biologic-device combination products differentiate medicines but present unique development and regulatory challenges. Manufacturers must ensure compliance with FDA regulations for these complex therapeutic and diagnostic tools.

Keywords:
BiologicsCGMPCombination productsDesign controlsFDAMedical deviceQuality systems

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Area of Science:

  • Biotechnology
  • Medical Device Development
  • Regulatory Science

Background:

  • Historically, biologic drug development focused on efficacy, with less emphasis on delivery devices.
  • The biotechnology market now differentiates products through patient-focused biologic-device combination products.
  • These products combine drugs, devices, and/or biologics, presenting unique challenges.

Purpose of the Study:

  • To highlight the challenges in developing and commercializing biologic-device combination products.
  • To discuss the regulatory landscape and the need for integrated development processes.
  • To emphasize manufacturer responsibility in ensuring compliance with FDA regulations.

Main Methods:

  • Analysis of the unique physicochemical and clinical considerations of biologic medicines.
  • Examination of the distinct development, review, and commercialization processes for biologics and devices.
  • Review of regulatory modernization efforts by agencies like the FDA.

Main Results:

  • Biologic-device combination products face significant development, regulatory, and commercialization hurdles.
  • Integrating biologic and device components requires addressing "cultural differences" in development and regulatory pathways.
  • Digital health trends are further complicating combination product development and review.

Conclusions:

  • Successful development of combination products necessitates a unified approach to design controls and risk management.
  • Modernized regulatory consultation processes are crucial for fostering innovation in safe and effective combination products.
  • Manufacturers must adhere to FDA regulations (21 CFR Part 4) and maintain robust quality systems.