Tag: ANDA

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Biorasi’s TALOS™ Platform and Unique Sites Win Unusual ANDA Trial

Biorasi’s TALOS™ Platform and Unique Site Win Unusual ANDA Trial Flexibility and Strong Process-driven Planning Overcomes Regulatory Speedbumps Download Case Study The Background:ANDA approval for therapies going off-patent are typically a staid affair. Timelines are established years in advance, procedures are standardized and well-tested, sites and patients are largely uniform …

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Navigating through the Clinical Trial Authorization Process in Russia

White Paper – Navigating through the Clinical Trial Authorization Process in Russia

Navigating through the Clinical Trial Authorization Process in Russia Clinical Endpoint ANDA Program Optimization White Paper Series Download White Paper

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Patient Numbers Required In Clinical Endpoint ANDA Trials

White Paper – Patient Numbers Required In Clinical Endpoint ANDA Trials

Patient Numbers Required In Clinical Endpoint ANDA Trials Clinical Endpoint ANDA Program Optimization White Paper Series Download White Paper

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Optimizing the Amount of Investigational Materials PART TWO

White Paper – Optimizing the Amount of Investigational Materials in ANDA Studies – Part Two

Optimizing the Amount of Investigational Materials in ANDA Studies – Part Two For Dermal Semisolid Clinical Studies White Paper Series Download White Paper

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Optimizing the Amount of Investigational Materials PART ONE

White Paper – Optimizing the Amount of Investigational Materials in ANDA Studies – Part One

Optimizing the Amount of Investigational Materials in ANDA Studies – Part One Clinical Endpoint ANDA Program Optimization White Paper Series Download White Paper

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Clinical Endpoint ANDA Program Optimization

White Paper – Clinical Endpoint ANDA Program Optimization Introduction

Clinical Endpoint ANDA Program Optimization This introduction marks the launch of a series of White Papers dealing with the optimization of Clinical Endpoint ANDA Programs for the generics and specialty pharmaceutical industry. We will be publishing these reports addressing and analyzing different aspects of optimization several times a year and …

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