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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

The FDA’s role in the regulation of botanical drug products includes an assessment of their safety and efficiency 5 but insufficient evidence for efficacy is one of the most common reasons why new drug candidates fail to reach this step. 10,12 The THR scheme is also limited to products used for oral or external use and/or inhalation.

Marketing 103
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Pfizer files blockbuster hope etrasimod for ulcerative colitis

pharmaphorum

Regulators in the US and EU have started a review of Pfizer’s S1P receptor modulator etrasimod for people living with moderately-to-severely active ulcerative colitis (UC), with decisions expected in the first halves of 2023 and 2024, respectively.

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Uncovering the potential of ADCs to target tumours

European Pharmaceutical Review

This covers nonclinical drug safety, translational and clinical pharmacology, drug metabolism and pharmacokinetics (DMPK) and pharmacometrics. 2024; 21 203–223 The post Uncovering the potential of ADCs to target tumours appeared first on European Pharmaceutical Review. Rise of Antibody-Drug Conjugates: The Present and Future.

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The Role of Certified Pharmaceutical Representatives in the Shifting Sales Landscape

Pharmaceutical Representative Training

The pharmaceutical industry is one of the most heavily regulated sectors due to the direct impact of its products on public health and safety. Several factors contribute to the stringent regulatory environment: Patient Safety: Ensuring that the pharmaceutical products are safe and effective is a crucial aspect. link] Reuters.

Sales 52
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Beyond animal testing: the rise of organs-on-chips technology

Clarivate

They became integral to physiological and pharmacological research during the 19th century and started to be systematically used for drug development during the 20th century. Since then, animal-based testing has been the gold standard for establishing a drug’s safety and efficacy. Clinical Pharmacology and Therapeutics, 104(6), pp.

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Efficacy of novel drug proven in MDD study

European Pharmaceutical Review

The data “are compelling, particularly the significant improvements observed in both depressive and anhedonic symptoms,” stated Dr Roger S McIntyre, FRCPC, Professor of psychiatry and pharmacology, University of Toronto and Executive Director of the Brain and Cognition Discovery Foundation in Toronto, Canada.

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FDA drug dosage optimisation guidelines signal clinical trial reform

Pharmaceutical Technology

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The clinical pharmacology knowledge also isn’t present at smaller companies, he adds.

FDA 115