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Related Concept Videos

Pharmacovigilance01:19

Pharmacovigilance

Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
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...
Structure-Activity Relationships and Drug Design01:28

Structure-Activity Relationships and Drug Design

Drug design is a dynamic field that involves discovering and developing new medications based on specific biological targets. This process heavily relies on structure-activity relationships (SAR) and quantitative structure-activity relationships (QSAR) to guide the design and optimization of efficient drugs.
SAR studies the intricate relationship between a drug's chemical structure and biological activity. It focuses on understanding how modifications to a drug's structure can influence its...
Bioavailability Study Design: Absolute Versus Relative Bioavailability01:27

Bioavailability Study Design: Absolute Versus Relative Bioavailability

Bioavailability is a crucial pharmacokinetic parameter that quantifies the proportion of an administered drug that reaches the systemic circulation and is available for therapeutic action. Regulatory agencies mandate the assessment of bioavailability, typically measured as the area under the drug plasma concentration-versus-time curve (AUC), to ensure the efficacy and safety of pharmaceutical products. These evaluations are categorized as absolute and relative bioavailability studies.Absolute...

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Related Experiment Video

Updated: May 28, 2026

Biosensor-based High Throughput Biopanning and Bioinformatics Analysis Strategy for the Global Validation of Drug-protein Interactions
08:31

Biosensor-based High Throughput Biopanning and Bioinformatics Analysis Strategy for the Global Validation of Drug-protein Interactions

Published on: December 1, 2020

Prevalent-New User Design for Biosimilar Safety Using Saudi Real-World Data.

Ohoud Almadani1, Almaha Alfakhri1, Ibrahim Asiri1

  • 1Saudi Food and Drug Authority, Riyadh, Saudi Arabia.

Pharmacoepidemiology and Drug Safety
|May 27, 2026
PubMed
Summary
This summary is machine-generated.

This study found no significant difference in infection risk between biosimilar and reference biological disease-modifying antirheumatic drugs (bDMARDs) in a Saudi real-world cohort. Further research is needed to enhance biosimilar surveillance using prevalent new-user designs.

Keywords:
Anti‐CD20B‐cellsTNF‐αbDMARDsbiologics

Related Experiment Videos

Last Updated: May 28, 2026

Biosensor-based High Throughput Biopanning and Bioinformatics Analysis Strategy for the Global Validation of Drug-protein Interactions
08:31

Biosensor-based High Throughput Biopanning and Bioinformatics Analysis Strategy for the Global Validation of Drug-protein Interactions

Published on: December 1, 2020

Area of Science:

  • Rheumatology
  • Pharmacovigilance
  • Real-world evidence

Background:

  • Infections are a concern with biological disease-modifying antirheumatic drugs (bDMARDs).
  • Post-marketing surveillance of biosimilar bDMARDs is crucial for patient safety.

Purpose of the Study:

  • To evaluate the infection risk associated with biosimilar bDMARDs compared to reference bDMARDs in a Saudi population.
  • To assess the utility of a prevalent new-user study design for biosimilar safety monitoring.

Main Methods:

  • A real-world cohort study using the Saudi Real-World Evidence Network (SRWEN) from 2016-2025.
  • Implemented a prevalent new-user design with time-conditional propensity score matching.
  • Assessed infection risk using ICD-10 codes, laboratory results, and antimicrobial prescriptions.

Main Results:

  • 5721 patients with 59,856 treatment episodes were analyzed; adalimumab was the most used drug.
  • Infection incidence rates were similar between biosimilar and reference bDMARD users (456.7 vs. 422.0 per 1000 person-years).
  • No statistically significant difference in infection risk was found (adjusted HR 0.89; 95% CI 0.57-1.39).

Conclusions:

  • No significant difference in infection risk between biosimilar and reference bDMARDs in the Saudi cohort.
  • The prevalent new-user design is applicable for biosimilar surveillance.
  • Larger studies are recommended to further validate findings and enhance post-marketing surveillance.