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Related Concept Videos

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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Bioavailability Enhancement: Determination and Conceptual Approaches in Overcoming Bioavailability Problems01:22

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Body:Bioavailability is a critical pharmacological concept that measures the extent and rate at which an active drug ingredient or therapeutic moiety enters the systemic circulation, remaining unchanged. It's a pivotal factor in determining a drug's efficacy and safety.The Biopharmaceutics Classification System (BCS) plays an essential role in drug development by categorizing drugs into four classes based on their solubility and permeability. This classification aids in understanding drug...
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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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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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Preclinical Development: Overview01:28

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Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
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Drug Discovery: Overview01:26

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Drug discovery is a multifaceted process involving extensive screening, testing, and optimization of lead compounds to identify potential new drugs for therapeutic use. It combines several approaches, including screening large numbers of natural products, chemical modification of known active molecules, identification of new drug targets, and rational design based on biological mechanisms and drug-receptor structure. These approaches are carried out in both academic research laboratories and...
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Patentability challenges associated with emerging pharmaceutical technologies.

Srishti Aggarwal1, Amrish Chandra1

  • 1Department of Drug Regulatory Affairs, Amity Institute of Pharmacy, Amity University, Noida, Uttar Pradesh, 201301, India.

Pharmaceutical Patent Analyst
|July 13, 2021
PubMed
Summary
This summary is machine-generated.

Emerging pharmaceutical technologies like AI and personalized medicine are rapidly advancing. Current patent laws struggle to address the unique challenges posed by these innovative healthcare solutions.

Keywords:
advanced biological therapiesartificial intelligencebig dataemerging trendspatent lawspersonalized medicinestem cell therapy

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Area of Science:

  • Pharmaceutical technology innovation
  • Healthcare industry advancements
  • Intellectual property law

Background:

  • Emerging technologies are gaining traction in the pharmaceutical sector.
  • Key areas include artificial intelligence, big data, personalized medicine, and stem cell therapy.
  • These technologies have significant applications across medicine and healthcare.

Purpose of the Study:

  • To analyze patent filing trends in the pharmaceutical sector.
  • To identify and discuss emerging technologies.
  • To examine the challenges posed by these technologies to current patent laws.

Main Methods:

  • Analysis of recent patent filing trends.
  • Review of emerging pharmaceutical technologies and their applications.
  • Discussion of legal and regulatory challenges.

Main Results:

  • Certain pharmaceutical technologies, including AI, big data, personalized medicine, and stem cell therapy, show increasing patent activity.
  • These emerging technologies offer diverse applications in healthcare.
  • Existing patent laws are found to be inadequate for addressing the complexities of these novel technologies.

Conclusions:

  • The rapid evolution of pharmaceutical technologies necessitates an update in patent law.
  • Addressing the unique challenges of AI, big data, personalized medicine, and stem cell therapy is crucial for fostering innovation.
  • Further research into adapting intellectual property frameworks is recommended.