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Self-Concept

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Self-concept is the cognitive and emotional understanding individuals hold about their identity. It evolves through various developmental stages, beginning in infancy and maturing as children grow. This concept influences how individuals perceive their abilities, interact with others, and manage challenges throughout life.
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The human nervous system handles vast amounts of information by translating sensory stimuli into neural impulses, which the brain processes, creating thoughts expressed through language or stored as memories. The brain also synthesizes information from emotions and memories, which significantly influence thoughts and behaviors. This intricate process creates a comprehensive mental picture.
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The concept of pressure at a point in a fluid establishes that pressure within a fluid is uniform in all directions at a specific location. This uniformity occurs because fluid molecules exert force evenly across any point due to their random motion and continuous collisions within the fluid. Pressure at a point is determined by the surrounding fluid molecules and is influenced by factors like depth and density, rather than by shape or orientation.
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The self-concept encompasses individuals' beliefs about themselves, structured through cognitive frameworks known as self-schemas. These schemas function as mental representations of specific traits or behaviors, influencing how self-relevant information is perceived, processed, and remembered. For example, individuals who are schematic for body weight are more likely to interpret routine experiences—such as dining out or shopping—through the lens of that trait. Conversely, those...
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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
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Biosimilars: Concepts and controversies.

Reyes Gámez-Belmonte1, Cristina Hernández-Chirlaque2, María Arredondo-Amador1

  • 1Department of Pharmacology, CIBERehd, School of Pharmacy, Instituto de Investigación Biosanitaria ibs.GRANADA, University of Granada, Spain.

Pharmacological Research
|February 12, 2018
PubMed
Summary
This summary is machine-generated.

Biosimilars are comparable versions of original biological drugs, not identical copies. This review clarifies concepts and controversies surrounding biosimilars, including extrapolation and immunogenicity.

Keywords:
BiosimilarComparability exerciseExtrapolation of indicationsImmunogenicity

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Area of Science:

  • Biopharmaceuticals
  • Drug Development
  • Regulatory Science

Background:

  • Biosimilars are analogous to generics for chemically synthesized drugs but differ significantly due to the complexity of biological manufacturing.
  • Biological drugs exhibit microheterogeneity and natural variations, preventing exact molecular identity replication.
  • Manufacturing process changes necessitate comparability exercises to ensure clinical equivalence between pre- and post-change versions.

Purpose of the Study:

  • To elucidate the fundamental concepts of biosimilars and their development.
  • To address prevalent controversies and misconceptions regarding biosimilar drugs.
  • To provide a comprehensive overview of the biosimilar landscape for researchers and clinicians.

Main Methods:

  • Review of existing scientific literature and regulatory guidelines on biosimilars.
  • Analysis of technical and regulatory distinctions between biosimilars and generics.
  • Examination of comparability exercises in the context of biological drug development and biosimilar approval.

Main Results:

  • Biosimilars are validated as comparable, not identical, to reference biologicals through extensive comparability exercises.
  • Key areas of controversy include extrapolation of indications, immunogenicity assessment, and substitution policies.
  • Understanding the nuances of biological complexity is crucial for evaluating biosimilars.

Conclusions:

  • Biosimilars represent a significant advancement in pharmaceutical development, offering alternatives to originator biologics.
  • Continued research and clear regulatory frameworks are essential to address ongoing controversies and foster biosimilar adoption.
  • This review provides a foundation for understanding the scientific and regulatory underpinnings of biosimilars.