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International regulation: the importance of quality assurance in drug development

European Pharmaceutical Review

As drug development professionals know, global health crises like the COVID-19 pandemic provide the public with valuable insights into how clinical research and regulatory processes work. What are the main challenges quality assurance and compliance professionals face during the drug development and review process?

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The Important Role that Biopharmaceutics Plays in Accelerating Early-Phase Drug Development

Pharmaceutical Technology

Biopharmaceutics is a scientific discipline that examines the interrelationship of the physicochemical properties of the drug, the dosage form in which the drug is given, and the route of administration on the rate and extent of systemic drug absorption ( Applied Biopharmaceutics and Pharmacokinetics, Shargel, Wu-Pong and Yu, 5th Edition ).

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How using AI in clinical trials accelerates drug development

Pharmaceutical Technology

Drug development is already a difficult endeavor, with the vast majority of R&D efforts failing to produce a market-worthy product. Even reaching the clinical trial phase offers no guarantees, as only 12% of such drugs receive U.S. While this process is essential, it’s also slow, expensive and unpredictable.

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Connecting with Patients at Home

Pharmacy Is Right For Me

There are so many different types of careers within the field of pharmacy—from research and drug development to pharmacy informatics! It also improves care coordination and eliminates communication gaps. It involves the training of community paramedics in performing some aspects of medication reconciliation.

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The rising importance of containment in small molecule drug development

Pharmaceutical Technology

HPAPIs may now represent more than 30% of the drug development pipeline. Within that figure, GlobalData estimates that around 60% of pipeline HPAPIs are developed to target oncology. Nowadays, you have drugs against cancer which have a very high impact even at a very low dosage.”.

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Can the FDA keep the momentum going for rare disease drug approvals?

Pharmaceutical Technology

Nicklas Westerholm, the CEO and president of orphan drug developer Egetis Therapeutics, says disease awareness amongst paediatric neurologists and endocrinologists is low for MCT8 deficiency. The FDA will weigh the concerns and benefits of this drug before its PDUFA date in October. compared to 38.5% on placebo.

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Patient Engagement in Pharma – Why and How?

Viseven

The traditional model of drug development and healthcare delivery is undergoing a seismic shift, with patient engagement emerging as a critical factor in achieving better health outcomes and driving innovation. This change is further driven by major regulatory bodies emphasizing Patient-Focused Drug Development (PFDD).