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Related Concept Videos

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Bioavailability Study Design: Healthy Subjects Versus Patients01:15

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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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Body: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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Updated: Nov 26, 2025

Preclinical Drug Testing in Scalable 3D Engineered Muscle Tissues
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Long-term safety data from the cladribine tablets clinical development program in multiple sclerosis.

T Leist1, S Cook2, G Comi3

  • 1Division of Clinical Neuroimmunology, Jefferson University, Comprehensive MS Center, Philadelphia, PA, USA.

Multiple Sclerosis and Related Disorders
|December 10, 2020
PubMed
Summary
This summary is machine-generated.

Long-term safety data for cladribine tablets 3.5 mg/kg in multiple sclerosis patients show no new major safety concerns. Integrated analysis confirms findings from earlier studies, supporting its established safety profile.

Keywords:
Cladribine tabletsLong-termMultiple sclerosis;, Safety

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Area of Science:

  • Pharmacovigilance and Clinical Safety
  • Neurology and Neuroimmunology
  • Drug Development and Regulatory Science

Background:

  • Cladribine tablets 3.5 mg/kg is an approved treatment for multiple sclerosis (MS).
  • Long-term safety data are crucial for newly approved MS therapies.
  • This study presents the final integrated safety analysis from the cladribine tablets clinical development program, including registry data.

Purpose of the Study:

  • To report the final integrated safety profile of cladribine tablets 3.5 mg/kg in patients with relapsing-remitting multiple sclerosis.
  • To assess serious adverse events (SAEs), infections, and malignancies over an extended observation period.
  • To consolidate safety findings from Phase III studies and the PREMIERE registry.

Main Methods:

  • Integrated safety data from three Phase III studies (CLARITY, CLARITY Extension, ORACLE-MS) and the PREMIERE registry were analyzed.
  • The cohort included 923 patients receiving cladribine tablets 3.5 mg/kg and 641 on placebo.
  • Adverse events (AEs) were assessed using observation-adjusted incidence rates per 100 patient-years (Adj-AE per 100 PY); malignancy rates were compared to GLOBOCAN data.

Main Results:

  • The cladribine tablets group reported a higher incidence of SAEs (14.4%) compared to placebo (10.6%).
  • Serious lymphopenia and herpes zoster were observed in the cladribine tablets group, with no placebo cases.
  • While herpetic infections were more frequent with cladribine tablets, overall infection rates did not differ; malignancy incidence was numerically higher but not statistically significant and comparable to general population rates.

Conclusions:

  • Extended patient observation did not significantly alter conclusions from interim analyses.
  • No new major safety concerns were identified in this consolidated safety analysis of cladribine tablets 3.5 mg/kg monotherapy.
  • The findings support the established safety profile of cladribine tablets in relapsing-remitting multiple sclerosis.