Category: clinical trial

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Latest FDA Bioequivalence Guidelines 2025: How the New Requirements Shape Your Generic Entry Strategy

The pharmaceutical landscape from 2025 onwards will undergo a structural shift driven by the latest FDA bioequivalence guidelines (2025). These guidelines are aimed at tightening study expectations while streamlining regulatory pathways for generics. For generic developers, this evolving BE framework is not just a compliance update. Rather, the new BE framework fundamentally impacts formulation strategy, […]

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The Brivaracetam Generic Opportunity: Patent Status, Market Dynamics, and Bioequivalence Study Design

Brivaracetam, commercially available as Briviact®, is an established antiepileptic medication approved for focal epilepsy management. It is used in conjunction with other medications to help control seizures. This drug is designed to offer pharmacologic differentiation from levetiracetam, including higher SV2A affinity and improved tolerability in select patients. Major patents for Briviact® are set to expire […]

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Choosing the Right Country for Your Clinical Trials in Complex Therapeutic Diseases: Why Investigator and Site Perspectives Count?

Choosing the right country for a clinical trial, particularly in complex therapeutic diseases, is a difficult task due to its reliance on factors that databases and standard metrics cannot fully measure. When therapies involve advanced technologies like modified immune cells or genetic interventions, the analysis must extend beyond basic feasibility. It requires examining site capabilities […]

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How to Supply Laboratory Kits to Clinical Trial Sites in Japan: A Step-by-Step Guide for Sponsors and CROs

Japan has one of the most tightly regulated pharmaceutical landscapes, which necessitates a seamless supply of laboratory kits (for clinical trials) to its sites. The process requires strict adherence to the guidelines of the Pharmaceuticals and Medical Devices Agency (PMDA). For sponsors and CROs, this raises the question of how to supply laboratory kits to […]

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Top 5 Challenges for Shipping Clinical Trial Materials to Japan: How Sponsors and CROs Can Overcome Them

Shipping clinical trial materials, such as ancillaries, medical devices, or Investigational Medicinal Products (IMPs), to Japan requires a thorough understanding of the laws and local regulatory systems. Understanding the challenges for shipping clinical trial materials to Japan begins with recognizing how the country’s regulatory framework differs from most others.  Japan’s clinical trial regulations differ from […]

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Conducting Clinical Trials on Traditional Medicine in the Asia-Pacific Region: Opportunities and Advantages

The Asia-Pacific region is home to a diverse array of traditional medicinal practices. The region is also rich in a large and diverse population. This diversity includes genetic variations, dietary patterns, environmental factors, and disease profiles, which makes trial results more applicable across global populations. Moreover, the growth of research facilities presents opportunities for sponsors […]

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Nutraceutical Clinical Trials: India as a Growing Hub

India is emerging rapidly as a global research and development hub for nutraceuticals. The country conducts nutraceutical clinical trials at lower costs while ensuring that the quality meets international standards. Nutraceutical clinical studies in India follow a regulated pathway, requiring approvals from both an Ethics Committee and the Central Drugs Standard Control Organization (CDSCO). It […]

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Navigating Budget Challenges in Clinical Trials: Practical Strategies for Cost Management

Effective cost management serves as a way to overcome budget challenges in clinical trials. A proper understanding of the key cost factors that emerge throughout the study lifecycle helps to mitigate such challenges. Factors such as patient recruitment, regulatory compliance, site management, and data collection each contribute significantly to the total expenditure. When the cost […]

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Ophthalmology Trials: Managing Protocol Deviations in Visual Function Assessments

Protocol deviations for Visual Function Assessments (VFAs) in ophthalmology trials can affect the accuracy and reliability of outcomes. A VFA measures an individual’s functional or practical visual capabilities. This is in contrast to a standard eye exam, which includes a series of tests to measure real-world visual skills. VFAs perform both quantitative and qualitative assessments […]

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Accelerating Clinical Trials: The Market Advantage of Early Engagement

In the drug development process, delaying the launch of a successful drug can result in lost sales. Early engagement to kickstart the clinical phase plays a key role in accelerating clinical trials and ultimately increasing revenue by providing earlier market access before competitors. Moreover, being the first to market a drug remains crucial for companies […]

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