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Related Concept Videos

Clinical Trials: Overview01:11

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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Drug Products: Biologics, Biosimilars and Interchangeables01:28

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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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Clinical Trials01:16

Clinical Trials

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Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
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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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Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

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

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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.
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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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Clinical trial development for biosimilars.

Rieke Alten1, Bruce N Cronstein2

  • 1Department of Internal Medicine II, Rheumatology, Clinical Immunology, Osteology, Schlosspark-Klinik, University Medicine Berlin, Berlin, Germany; Rheumatology Research Center, Rheumatology, Clinical Immunology, Osteology, Schlosspark-Klinik, University Medicine Berlin, Berlin, Germany.

Seminars in Arthritis and Rheumatism
|June 11, 2015
PubMed
Summary
This summary is machine-generated.

Biosimilar clinical trial design in the EU and US is discussed, focusing on monoclonal antibodies for inflammatory diseases. Key considerations include pharmacokinetic and pharmacodynamic studies to ensure biosimilar similarity.

Keywords:
Biosimilarbiologicchronic inflammatory diseasesclinical studies, comparabilityimmunogenicity, extrapolationpharmacodynamicspharmacokineticsreference productregulatory guidancessafetystudy design

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Area of Science:

  • Biopharmaceuticals
  • Clinical Trial Design
  • Immunology

Background:

  • Biosimilars offer alternatives to originator biologics.
  • Monoclonal antibodies are crucial for treating inflammatory diseases.
  • Regulatory pathways for biosimilar approval differ between the EU and US.

Purpose of the Study:

  • To discuss clinical trial design challenges for biosimilars.
  • To focus on monoclonal antibodies for inflammatory conditions.
  • To compare EU and US regulatory approaches.

Main Methods:

  • Literature search of PubMed and internet databases.
  • Review of European Medicines Agency (EMA) and US Food and Drug Administration (FDA) guidelines.
  • Keywords included biosimilar and various inflammatory diseases.

Main Results:

  • The EMA has a mature biosimilar approval pathway with numerous approvals.
  • The US FDA has issued draft guidances but has not yet approved a biosimilar.
  • Clinical trials are essential to confirm biosimilarity post-nonclinical development.

Conclusions:

  • Pharmacokinetic and pharmacodynamic studies are foundational for early clinical development.
  • Phase 3 clinical development is informed by early studies.
  • Critical factors for clinical trial design include population, endpoints, sample size, and duration.