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Oncology Bioequivalence Clinical Studies

ProRelix Research

The post Oncology Bioequivalence Clinical Studies appeared first on ProRelix Research. According to the World Health Organization (WHO), cancer is the leading cause of death worldwide, accounting for nearly 10 million deaths in 2020 (1). In addition, GLOBACAN estimated 19.3 […].

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Samsung Bioepis’ SB12 Soliris® (Eculizumab) Biosimilar Demonstrates PK, PD Bioequivalence in Phase 1 Study

BioTech 365

Samsung Bioepis’ SB12 Soliris® (Eculizumab) Biosimilar Demonstrates PK, PD Bioequivalence in Phase 1 Study Samsung Bioepis’ SB12 Soliris® (Eculizumab) Biosimilar Demonstrates PK, PD Bioequivalence in Phase 1 Study Phase 1 study demonstrated pharmacokinetics (PK) equivalence and comparable pharmacodynamic (PD), safety, … Continue reading → (..)

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Alpha Cognition announces bioequivalence study results for Alzheimer’s

Pharma Times

In 2019, there were over 850,000 people with dementia in the UK, representing one in every 14 people aged 65 and over

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CRO Data Integrity Concerns Have Pharma Companies Scrambling to Repeat Bioequivalence Studies

BioSpace

The announcement came following independent FDA analyses of inspections conducted at the two CROs in November 2019.

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FDA approves IntelGenx’s Rizafilm for acute migraine treatment

Pharmaceutical Technology

The approval was based on successful results from a bioequivalence study comparing Rizafilm to Merck and Co’s Maxalt-MTL and the European reference Maxalt-Lingua. IntelGenx Corp announced that the US Food and Drug Administration (FDA) has approved the company’s Rizafilm VersaFilm new drug application (NDA) for the treatment of acute migraine.

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A PSA on PSGs: PSG Meetings Are Now Available

FDA Law Blog

Koblitz — FDA uses its Product Specific Guidance documents (“PSGs”) to provide recommendations as to the bioequivalence testing necessary for approval of a generic drug. FDA may deny a PSG if the applicant’s bioequivalence testing started after the PSG publication.

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Dormant drug status can trigger generic access to an alternate Canadian Reference Product

Pharma in Brief

For instance, the generic drug must be “the pharmaceutical equivalent of the [CRP]” and be “bioequivalent with the [CRP]”. According to the Notice, the alternate CRP is preferably another generic drug that has demonstrated bioequivalence with the “Dormant” innovative drug.