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Related Concept Videos

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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Psychodynamic Perspectives on Personality01:27

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The psychodynamic perspective in psychology asserts that most personality functions operate unconsciously, outside of awareness. This means that the motives and emotions driving behavior often remain hidden, automatically buried in the unconscious mind as a defense mechanism to shield us from psychological distress. According to this theory, the unconscious mind contains thoughts, memories, and emotions that are too disturbing to face directly.
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The Behavioral Perspective on Personality01:19

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Behaviorists view personality as primarily shaped by environmental reinforcements and consequences. According to this perspective, behavior is influenced by external stimuli, and individuals adjust their actions based on rewards and punishments. Over time, learning histories — accumulated patterns of reinforcement — play a significant role in shaping personality. Behaviors that lead to positive outcomes are reinforced, while those resulting in negative outcomes are diminished.
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Criticisms of the Evolutionary Perspective01:23

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In a study where individuals posing as strangers offered compliments and proposed casual sex to students, the responses differed significantly based on gender. Not a single woman accepted the proposal, while 70% of the men agreed. This outcome provides a useful scenario to explore through the lens of evolutionary psychology and social learning theory, highlighting the diverse perspectives on human sexual behaviors.
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Social Cognitive Perspective on Personality01:30

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Social cognitive perspectives on personality emphasize the importance of conscious awareness, beliefs, expectations, and goals in shaping behavior. These perspectives incorporate behaviorist principles, such as learning through reinforcement and conditioning, but extend beyond them by highlighting human reasoning and planning. Unlike traditional behaviorist views, social cognitive theory focuses on how individuals reflect on their past experiences and plan for future outcomes by considering...
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The first thing a clinician sees is the skin, so the examination of the skin should be part of any thorough physical examination. Most skin disorders are relatively benign, but a few, including melanomas, can be fatal if untreated. A couple of the more noticeable disorders, albinism and vitiligo, affect the appearance of the skin and its accessory organs.
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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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Current perspectives on biosimilars.

Frank K Agbogbo1, Dawn M Ecker2, Allison Farrand3

  • 1Cytovance Biologics, 800 Research Parkway, Suite 200, Oklahoma City, OK, 73104, USA. fagbogbo@cytovance.com.

Journal of Industrial Microbiology & Biotechnology
|July 19, 2019
PubMed
Summary
This summary is machine-generated.

Biosimilars offer a cost-effective alternative to innovator drugs with shorter approval timelines. This review covers the biosimilar market, pipeline, analytical development, and manufacturing considerations for successful product realization.

Keywords:
AnalyticalBiosimilarsMammalianManufacturingMicrobialQuality

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Area of Science:

  • Biopharmaceutical development
  • Drug regulatory affairs

Background:

  • Biosimilars present a significant opportunity in the pharmaceutical market, offering lower-cost alternatives to originator biologics.
  • The development pathway for biosimilars differs from innovator drugs, requiring a robust analytical strategy and adherence to stringent quality management systems.

Purpose of the Study:

  • To provide a comprehensive overview of the biosimilar market, pipeline, and industry targets.
  • To discuss the unique analytical requirements and manufacturing considerations for biosimilar development.
  • To highlight decision-making processes for optimizing biosimilar development based on cost, time, and efficacy.

Main Methods:

  • Review of the current biosimilar market landscape and pipeline.
  • Analysis of quality management systems (QMS) for data traceability.
  • Exploration of analytical similarity strategies for biosimilar characterization.
  • Case study on development decisions, including process parameter and method selection.
  • Discussion of manufacturing factors and target-directed development approaches.

Main Results:

  • Biosimilars demonstrate a shorter approval timeline (8 years) and reduced development costs (10-20%) compared to innovator drugs.
  • A broader analytical foundation is essential for biosimilar development, necessitating advances in analytical similarity characterization.
  • Strategic decisions in process parameter and method selection are crucial for cost-effective and timely biosimilar development.

Conclusions:

  • Successful biosimilar development requires a thorough understanding of the market, a robust QMS, and advanced analytical characterization.
  • Optimizing process parameters and manufacturing strategies is key to achieving target-directed development and market viability.
  • Biosimilars offer a viable and cost-effective therapeutic option, driven by strategic development and manufacturing approaches.