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Guidebook for Drug Regulatory Submissions

The high-stakes process of submitting drug documents and applications for regulatory review can be intimidating, particularly for the;

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Good Drug Regulatory Practices

Good Drug Regulatory Practices offers a series of policies and procedures to assure quality and timely regulatory submissions to national;

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Innovative Methods for Rare Disease Drug Development

study designs and statistical methods for rare diseases drug development including n-of-1 trial design, adaptive trial design, and master;

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Innovative Methods for Rare Disease Drug Development

study designs and statistical methods for rare diseases drug development including n-of-1 trial design, adaptive trial design, and master;

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Innovative Statistics in Regulatory Science

. This book is devoted to the discussion of statistics in regulatory science for pharmaceutical development. It covers practical issues that are;

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Innovative Statistics in Regulatory Science

. This book is devoted to the discussion of statistics in regulatory science for pharmaceutical development. It covers practical issues that are;

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Development of Vaccines

, challenges and solutions for progressing a biologic drug formulation from its early stage of discovery into its final clinical testing. A section;

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Drug Delivery Trends

Realities of Multifunctional Drug Delivery Systems examines the fabrication, optimization, biological aspects, regulatory and clinical success;

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Delivery of Drugs

examine the specific aspects of characterization and manufacturing of drug delivery system for pharmaceutical application and its regulatory;

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Accelerated Predictive Stability (APS)

pharmaceutical industry. In addition, up-to-date experiences in utilizing APS data for regulatory submissions in many regions and countries highlight the;

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Regulatory Intelligence as the Basis for Regulatory Strategy and Global Drug Development

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Drug-Drug Interactions: Scientific and Regulatory Perspectives

point-of-view of academia, industry, and government regulatory agencies. This book is intended for professionals in the pharmaceutical industry;

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Building a National Framework for the Establishment of Regulatory Science for Drug Development

, to examine the state of regulatory science and to consider approaches for enhancing it.;

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Drug Delivery Aspects

on formulation engineering and related large scale (GMP) manufacturing, regulatory, and functional aspects of drug delivery systems. A;

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Interface between Regulation and Statistics in Drug Development

for regulatory purposes, numerous guidelines have been issued by regulatory authorities around the world focusing on statistical issues;

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Interface between Regulation and Statistics in Drug Development

for regulatory purposes, numerous guidelines have been issued by regulatory authorities around the world focusing on statistical issues;

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FDA Regulatory Affairs

FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain;

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Generic Drug Product Development

and bioequivalence for specialty drug products. It describes various scientific approaches and regulatory requirements for manufacturers who;

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Nanopharmaceuticals

therapy and serves as a single dose magic bullet for multiple drug delivery with improved drug efficiency at a lower dose, transportation of the;

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Generic Drug Product Development

and bioequivalence for specialty drug products. It describes various scientific approaches and regulatory requirements for manufacturers who;

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New Drug Approval Process

in filing US and global INDs, NDAs, BLAs, ANDAs, and SNDAs the latest regulatory requirements for expediting new drug approvals strategies for;

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Power, Politics and Pharmaceuticals

Central questions that are explored include: What are the implications for health of existing systems of pharmaceutical drug regulation;

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Health Technology Assessment: Using Biostatistics to Break the Barriers of Adopting New Medicines

shortcomings of submissions for drug and device reimbursement. The book begins by contrasting the differences between regulatory approval and;

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Health Technology Assessment: Using Biostatistics to Break the Barriers of Adopting New Medicines

shortcomings of submissions for drug and device reimbursement. The book begins by contrasting the differences between regulatory approval and;

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Long-Acting Drug Delivery Systems: Pharmaceutical, Clinical, and Regulatory Aspects

Long-Acting Drug Delivery Systems: Pharmaceutical, Clinical, and Regulatory Aspects offers a comprehensive overview of the technical;

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Drug-Drug Interactions in Pharmaceutical Development

Drug-Drug Interactions in Pharmaceutical Development comprehensively reviews the relevant science, industrial practice, and regulatory;

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Innovative Methods for Rare Disease Drug Development

Innovative Methods for Rare Diseases Drug Development focuses on biostatistical applications in terms of design and analysis;

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