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Understanding the Regulatory Environment in Japan for Generic Drug Development

Drug Patent Watch

The regulatory environment in Japan for generic drug development is complex and has undergone significant changes in recent years. Regulatory Authority: Pharmaceuticals and Medical Devices Agency (PMDA) The PMDA is the primary regulatory authority responsible for overseeing the drug approval process in Japan.

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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.

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Are Gaps in Your Clinical Pharmacology Program Jeopardizing Your Drug’s Approval?

Fierce BioTech

Are Gaps in Your Clinical Pharmacology Program Jeopardizing Your Drug’s Approval? Eva Gil Berglund, PhD Justin Hay, PhD Paola Coppola, MSc Duration 60 Minutes Clinical pharmacology information comprises more than 50% of a drug label. Click here to login. Listing Image Certara-LogoListing-12052023.png

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The rising impact of biomarkers in early clinical development

Drug Target Review

In a recent survey conducted by ICON, Plc, biomarker selection was identified by 35 percent of respondents as a top challenge among drug developers for phase I trials, second only to navigating regulatory compliance (- 38 percent). To qualify as endpoints, biomarkers used in early phases must be relevant to later stages of drug development.

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Antibody Drug Conjugates: windows of opportunity

Drug Target Review

Over the last two decades, an increasing number of Antibody Drug Conjugate (ADC) therapeutics have been approved for oncology indications. These therapies have broadened treatment options for patients to expand beyond the more traditional small molecule drug alternatives. 3D rendering of Antibody Drug Conjugate Molecules.

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

Alta Sciences

Altasciences’ Commitment to Supporting Pharma and Biotech With Comprehensive Bioanalytical Services pmjackson Wed, 11/13/2024 - 14:50 Greater Montréal, Québec, 11/13, 2024 — Altasciences , a trusted drug development research partner for over 30 years, continues its commitment to providing world-class bioanalytical services.

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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. While it may not seem like a priority at first glance, the success of a drug can hinge on early decisions around artwork.