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Related Concept Videos

Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

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...
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

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.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
Preclinical Development: Overview01:28

Preclinical Development: Overview

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...
Pharmacodynamics: Overview and Principles01:21

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Pharmacodynamics is a scientific field that delves into drugs' intricate biochemical, cellular, and physiological effects on the human body. The study of pharmacodynamics helps us understand how drugs interact with the body and elicit various responses.
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Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions01:15

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PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure (CHF).
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Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
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Guidelines, editors, pharma and the biological paradigm shift.

Ajai R Singh1, Shakuntala A Singh

  • 1Editor, MSM.

Mens Sana Monographs
|November 8, 2011
PubMed
Summary

The pharmaceutical industry

Keywords:
AcademiaAcademic Medical CentersBest Practice GuidelinesBiological PsychiatryClinical Practice GuidelinesClinical ResearchCorporate WelfareLaw Suits Against IndustryMedical AssociationsPharma ImagePharmaceutical IndustryPublic WelfareResearch Journals

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Area of Science:

  • Biomedical research
  • Pharmaceutical industry ethics
  • Conflict of interest in research

Background:

  • Private investment in biomedical research has surged, leading to increased industry influence.
  • This has created significant conflicts of interest, impacting patient welfare over profit motives.
  • Concerns include patent disputes, research misconduct, and biased clinical practice guidelines.

Purpose of the Study:

  • To examine the ethical challenges and conflicts of interest arising from pharmaceutical industry involvement in biomedical research.
  • To highlight instances where commercial interests may supersede patient welfare.
  • To propose solutions for maintaining credibility and patient-centricity in pharmaceutical research and marketing.

Main Methods:

  • Analysis of industry practices, including marketing strategies and reporting of research findings.
  • Review of existing guidelines and ethical frameworks concerning industry-academia interactions.
  • Examination of case studies illustrating conflicts between profit motives and patient safety.

Main Results:

  • Industry influence is pervasive, affecting clinical trials and practice guidelines, with financial ties often undisclosed.
  • Pharmaceutical companies sometimes prioritize marketability over genuine drug efficacy and patient well-being.
  • Questionable tactics are employed to maintain profitability, including misrepresenting drug effectiveness and side-effect profiles.

Conclusions:

  • There is a critical need for transparency and ethical conduct in pharmaceutical research and marketing.
  • Balancing profit motives with patient welfare is essential for long-term credibility.
  • Implementing stricter codes of conduct and regulatory oversight can mitigate conflicts of interest and protect research subjects.