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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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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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The potency of a drug is the measure of its ability to produce a biological response and can be compared by looking at the half-maximum effective concentration or EC50 values of different drugs. A lower EC50 value indicates higher potency of the drug. In the dose–response curve of two antihypertensive drugs, candesartan and irbesartan, a significant difference is observed in their EC50 values. A lower EC50 value for candesartan indicates that it is more potent than irbesartan, as it...
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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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Drug Concentrations: Measurements01:23

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Drug concentration is the quantity of a drug present in a biological sample. Measuring drug amounts in biological samples allows the clinician to understand how a drug is absorbed, distributed, metabolized, and excreted. Samples can be obtained through invasive or non-invasive methods. Invasive techniques involve surgical or parenteral interventions to gather blood, cerebrospinal fluid, or tissue biopsy. Conversely, non-invasive approaches provide samples like urine, feces, and saliva.
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Updated: Jul 28, 2025

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Potency Assay Development: A Keystone for Clinical Use.

Raffaela Torggler1, Eva Margreiter1, Rainer Marksteiner1

  • 1Innovacell AG, Innsbruck, Austria.

Advances in Experimental Medicine and Biology
|May 31, 2023
PubMed
Summary
This summary is machine-generated.

Developing a reliable potency assay is crucial for Advanced Therapy Medicinal Products (ATMPs). This quantitative measure of biological activity ensures product quality, consistency, and clinical efficacy for market approval.

Keywords:
ATMPAssay developmentBiological activityCell therapyClinical efficacyClinical usePotency assayQuality controlStability testingSurrogate marker

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Area of Science:

  • Biotechnology
  • Pharmacology
  • Quality Control

Background:

  • Potency quantifies the biological activity of Advanced Therapy Medicinal Products (ATMPs), essential for clinical efficacy.
  • Potency testing is a mandatory component of quality control for ATMP batch release and market approval.

Purpose of the Study:

  • To highlight the critical need for developing reliable and accurate potency assays for ATMPs.
  • To emphasize the importance of defining the mode of action and relevant biological activity for assay development.
  • To outline the integration of potency assays into the ATMP manufacturing and quality control processes.

Main Methods:

  • Defining the mode of action to identify relevant biological activities for measurement.
  • Initiating potency assay development early in the product lifecycle.
  • Progressively implementing the assay into manufacturing, quality control, and release.

Main Results:

  • Potency assays are vital for assessing product stability and manufacturing consistency.
  • They help detect the impact of process changes and estimate clinical efficacy.
  • Well-established assays define the effective dose and ensure batch-to-batch quality.

Conclusions:

  • A robust potency assay is indispensable for the clinical application of ATMPs.
  • Early development and integration of potency testing ensure product quality and regulatory compliance.
  • Accurate potency measurement is fundamental for demonstrating the safety and efficacy of ATMPs.