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The rising impact of biomarkers in early clinical development

Drug Target Review

For example, transcriptomic processes are showing the potential to identify and track failures in gene expression and gene regulation of amyloid and tau-related biomarkers, understood as precursors to the onset of Alzheimers disease (AD). Clinical Pharmacology and Therapeutics. Clinical Pharmacology and Therapeutics.

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Clinical Pharmacology Considerations for Peptide Drug Products

thought leadership

The FDA has recently issued this draft guidance to address clinical pharmacology considerations for peptide drug products. These products fall somewhere between drugs and biologics and do not have the usually well-defined characteristics of either category. A peptide is any polymer with 40 or fewer amino acids.

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Understanding the Regulatory Environment in Japan for Generic Drug Development

Drug Patent Watch

Pharmaceutical companies must navigate the PMDA’s requirements and guidelines to ensure successful approval and marketing of their products. Clinical Pharmacology & Therapeutics , 111(3), 531538. Pharmaceutical Regulations in Japan 2020. Journal of Clinical Pharmacology , 51(3), 531538.

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Optimized 505(b)(1) and 505(b)(2) Clinical Pharmacology Programs to Accelerate Drug Development

The Premier Consulting Blog

In this blog, we explain the role of clinical pharmacology in drug development and demonstrate how the right strategy can accelerate development under the US Food and Drug Administration (FDA) 505(b)(1) and 505(b)(2) New Drug Application (NDA) pathways. food effect, smoking, and drug-drug interactions) on drug exposure and response.

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Antibody Drug Conjugates: windows of opportunity

Drug Target Review

1 Regulators invest significant consideration balancing quality-of-life measures with overall survival when assessing novel oncology treatments. At Abenza, Jeff is a strategist providing market, product and regulatory guidance to early and late phase development projects by leveraging quality management and risk mitigation approaches.

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Shaping drug development success: how does artwork play a role?

Drug Target Review

This continued innovation highlights the complexity of the drug development process, particularly as the field is highly regulated by health authorities around the world. The preclinical role of often-overlooked artwork During preclinical stages, labelling decisions can significantly impact clinical trials and eventual drug commercialisation.

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A Closer Look At Our On-Site Compounding Pharmacies

Alta Sciences

Adherence to harmonized pharmacy-specific SOPs based on cGMP principles at our three clinical pharmacology units. Exceptional inspection results from major regulators such as the FDA, HC, EMA, and MHRA. We also provide analytical testing, ICH stability storage and testing, as well as finished product and release testing.