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

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Stronger Food and Drug Regulatory Systems Abroad

of regulatory systems for public health, development, and trade. At the request of the FDA, this study sets out a strategy to support good quality;

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Peptide Therapeutics

Peptide therapy has become a key strategy in innovative drug development, however, one of the potential barriers for the development;

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Interface between Regulation and Statistics in Drug Development

, medical researchers, and regulatory personnel in drug development, as well as graduate students in the health sciences. The authors' decades;

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Interface between Regulation and Statistics in Drug Development

, medical researchers, and regulatory personnel in drug development, as well as graduate students in the health sciences. The authors' decades;

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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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International Regulatory Harmonization Amid Globalization of Drug Development

the need and prospects for greater international regulatory harmonization for drug development, the IOM Forum on Drug Discovery, Development;

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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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Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development

The development and application of regulatory science - which FDA has defined as the science of developing new tools, standards, and;

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Innovative Statistics in Regulatory Science

/margin selection and complex innovative design such as adaptive trial design) in the pharmaceutical development and regulatory approval process;

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Innovative Statistics in Regulatory Science

selection and complex innovative design such as adaptive trial design) in the pharmaceutical development and regulatory approval process;

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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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Generic Drug Product Development

measurement of drug product quality and performance, as well as the regulatory and scientific requirements of topical, nasal and inhalation, and;

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Medical Product Regulatory Affairs

regulatory affairs in all major global markets for pharmaceuticals and medical devices. Following a look at drug development, complete sections are;

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New Drug Development

development understand regulatory steps, reduce cost by avoiding unnecessary trials, and attain guidance through each step of the drug approval;

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Generic Drug Product Development

contributors discuss measurement of drug product quality and performance, as well as the regulatory and scientific requirements of topical, nasal and;

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Regulatory and Pharmacological Basis of Ayurvedic Formulations

Regulatory affairs and pharmacological drug safety issues of Ayurvedic medicine has been overlooked by practitioners for many years;

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Regulatory and Pharmacological Basis of Ayurvedic Formulations

Regulatory affairs and pharmacological drug safety issues of Ayurvedic medicine has been overlooked by practitioners for many years;

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Biosimilars

This book provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for;

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International regulatory co-operation

, which exposed the vulnerabilities of global health, economic and governance systems, it is time for a true paradigm shift towards more;

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Drug Delivery Systems

Drug delivery technologies represent a vast, vital area of research and development in pharmaceuticals. The demand for innovative drug;

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Pharmaceutical Analysis for Small Molecules

A comprehensive introduction for scientists engaged in new drug development, analysis, and approvals Each year the pharmaceutical;

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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

degrees of familiarity or experience with the CMC strategy and regulatory compliance requirements for these challenging products. Companies;

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Drug Delivery Aspects

, regulatory challenges and in vivo success stories. Throughout the volumes discussions on diverse aspects of drug delivery carriers, such as clinical;

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Drug Delivery Trends

, regulatory challenges and in vivo success stories. Throughout the volumes discussions on diverse aspects of drug delivery carriers, such as clinical;

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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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