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The rising impact of biomarkers in early clinical development

Drug Target Review

As our understanding of the underlying biology of disease grows more sophisticated, emerging therapies operate on increasingly complex biopathological systems and mechanisms. Safety biomarkers account for adverse effects of a therapy under study. There are several types of biomarkers to consider.

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Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development

Alta Sciences

Food and Drug Administration (FDA) issued two guidance documents outlining the necessary evaluations during the clinical development of oligonucleotide therapeutics: Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics and Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics .

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Altasciences’ Commitment to Supporting Pharma and Biotech With Comprehensive Bioanalytical Services

Alta Sciences

To promote Altasciences’ bioanalytical services from discovery to Phase IV, they recently launched their Unveiling the Invisible video campaign to showcase how their bioanalytical solutions provide critical insights that unveil the invisible and drive the creation of innovative therapies. View the fascinating video series here.

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Landiolol

New Drug Approvals

“Pharmacokinetics of landiolol hydrochloride, a new ultra-short-acting beta-blocker, in patients with cardiac arrhythmias” Clinical Pharmacology and Therapeutics. New Drug Therapy Approvals 2024 (PDF). “Metoprolol Therapy and CYP2D6 Genotype” In Pratt VM, McLeod HL, Rubinstein WS, et al.

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Integrating Bioanalytical Automation, Biomarkers, Pharmacogenomics, & Cost-Effective Strategies

Conversations in Drug Development Trends

Transforming Drug Development with Biomarkers and Streamlined Regulatory Pathways The growing focus on addressing unmet medical needs has prompted regulatory agencies to streamline pathways to expedite access to transformative therapies. As a cornerstone of the 4P model, PGx plays a transformative role in advancing personalized care.

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FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What Questions Did They Answer? (Part 1)

FDA Law Blog: Drug Discovery

Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. The draft guidance enumerates key considerations for selecting an animal species for both pharmacology and toxicology studies.

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Antibody Drug Conjugates: windows of opportunity

Drug Target Review

These therapies have broadened treatment options for patients to expand beyond the more traditional small molecule drug alternatives. Patients and caregivers also assess the benefits offered by different therapies, weighing the progression-free survival with their off-target effects. Translational and Clinical Pharmacology [Internet].