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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 offers a series of policies and procedures to assure quality and timely regulatory submissions to national;
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study designs and statistical methods for rare diseases drug development including n-of-1 trial design, adaptive trial design, and master;
Vergelijkbare producten zoals 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;
Vergelijkbare producten zoals Innovative Methods for Rare Disease Drug Development
. This book is devoted to the discussion of statistics in regulatory science for pharmaceutical development. It covers practical issues that are;
Vergelijkbare producten zoals 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;
Vergelijkbare producten zoals Innovative Statistics in Regulatory Science
, challenges and solutions for progressing a biologic drug formulation from its early stage of discovery into its final clinical testing. A section;
Vergelijkbare producten zoals Development of Vaccines
Realities of Multifunctional Drug Delivery Systems examines the fabrication, optimization, biological aspects, regulatory and clinical success;
Vergelijkbare producten zoals Drug Delivery Trends
examine the specific aspects of characterization and manufacturing of drug delivery system for pharmaceutical application and its regulatory;
Vergelijkbare producten zoals Delivery of Drugs
pharmaceutical industry. In addition, up-to-date experiences in utilizing APS data for regulatory submissions in many regions and countries highlight the;
Vergelijkbare producten zoals Accelerated Predictive Stability (APS)
point-of-view of academia, industry, and government regulatory agencies. This book is intended for professionals in the pharmaceutical industry;
Vergelijkbare producten zoals Drug-Drug Interactions: Scientific and Regulatory Perspectives
, to examine the state of regulatory science and to consider approaches for enhancing it.;
Vergelijkbare producten zoals Building a National Framework for the Establishment of Regulatory Science for Drug Development
on formulation engineering and related large scale (GMP) manufacturing, regulatory, and functional aspects of drug delivery systems. A;
Vergelijkbare producten zoals Drug Delivery Aspects
for regulatory purposes, numerous guidelines have been issued by regulatory authorities around the world focusing on statistical issues;
Vergelijkbare producten zoals 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;
Vergelijkbare producten zoals Interface between Regulation and Statistics in Drug Development
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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and bioequivalence for specialty drug products. It describes various scientific approaches and regulatory requirements for manufacturers who;
Vergelijkbare producten zoals Generic Drug Product Development
therapy and serves as a single dose magic bullet for multiple drug delivery with improved drug efficiency at a lower dose, transportation of the;
Vergelijkbare producten zoals Nanopharmaceuticals
and bioequivalence for specialty drug products. It describes various scientific approaches and regulatory requirements for manufacturers who;
Vergelijkbare producten zoals Generic Drug Product Development
in filing US and global INDs, NDAs, BLAs, ANDAs, and SNDAs the latest regulatory requirements for expediting new drug approvals strategies for;
Vergelijkbare producten zoals New Drug Approval Process
Central questions that are explored include: What are the implications for health of existing systems of pharmaceutical drug regulation;
Vergelijkbare producten zoals Power, Politics and Pharmaceuticals
shortcomings of submissions for drug and device reimbursement. The book begins by contrasting the differences between regulatory approval and;
Vergelijkbare producten zoals 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;
Vergelijkbare producten zoals Health Technology Assessment: Using Biostatistics to Break the Barriers of Adopting New Medicines
Long-Acting Drug Delivery Systems: Pharmaceutical, Clinical, and Regulatory Aspects offers a comprehensive overview of the technical;
Vergelijkbare producten zoals Long-Acting Drug Delivery Systems: Pharmaceutical, Clinical, and Regulatory Aspects
Drug-Drug Interactions in Pharmaceutical Development comprehensively reviews the relevant science, industrial practice, and regulatory;
Vergelijkbare producten zoals Drug-Drug Interactions in Pharmaceutical Development
Innovative Methods for Rare Diseases Drug Development focuses on biostatistical applications in terms of design and analysis;
Vergelijkbare producten zoals Innovative Methods for Rare Disease Drug Development
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