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Preclinical Safety Evaluation of Biopharmaceuticals

responsibilities include the evaluation of novel therapies. --From the Afterword by Anthony D. Dayan Proper preclinical safety evaluation can improve the;

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Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics

pertinent international regulatory guidance documents for nonclinical evaluationCovers early de-risking strategies and designs of safety;

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Histopathology of Preclinical Toxicity Studies

drug-induced pathologies and applicable species comparisons to aid in the preclinical safety assessment of new medicines. This updated;

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ChitosanBased Systems for Biopharmaceuticals

* preclinical and clinical use of chitosan and derivatives for biopharmaceuticals Chitosan-Based Systems for Biopharmaceuticals is an important;

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Quality Assurance for Biopharmaceuticals

safety, purity and efficacy of the products produced.;

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Advances in Pharmaceutical Cell Therapy

of stem cell and cell-based products, it traces the long and complex journey from preclinical concept to initiation of a pivotal clinical trial;

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Clinical Trials of Drugs and Biopharmaceuticals

activity and the processes of drug evaluation is essential. Clinical Trials of Drugs and Biopharmaceuticals provides an overview of current;

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Preclinical Development Handbook

This book brings together in one resource an overview of the preclinical process along with a compendium of methods and techniques that;

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Preclinical Development Handbook

also set forth the limitations of various methods and techniques used in determining the safety and efficacy of a drug during the preclinical;

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Preclinical Development Handbook

preclinical safety tests to meet all FDA requirements before clinical trials may begin.;

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Evaluation of Drug Candidates for Preclinical Development

sections on pharmacokinetics and drug metabolism, integration of pharmaceutical development, and predictive safety assessment. Topics include: cost;

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Drug-Induced Mitochondrial Dysfunction

This is the definitive, one-stop resource on preclinical drug evaluation for potential mitochondrial toxicity, addressing the issue upfront;

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Quantitative Evaluation of Safety in Drug Development

Evaluation of Safety in Drug Development: Design, Analysis and Reporting explains design, monitoring, analysis, and reporting issues for both;

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Delivery Technologies for Biopharmaceuticals

Successful delivery of biopharmaceuticals is a major challenge because their molecular properties le;...

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Methodologies for Seismic Safety Evaluation of Existing Nuclear Installations

publication covers the seismic safety evaluation programmes to be performed on existing nuclear installations in order to ensure that the required;

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Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems

specific details such as historical perspective, preclinical testing, safety, and toxicology evaluation, as well as regulatory, quality, and;

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Vaccines: From Concept to Clinic

imagination, to the lab bench, through preclinical evaluation, and into the clinic for safety and immunogenicity. The result of the editors' own;

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Vaccines: From Concept to Clinic

imagination, to the lab bench, through preclinical evaluation, and into the clinic for safety and immunogenicity. The result of the editors' own;

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Fusion Protein Technologies For Biopharmaceuticals

of marketed drugs with the dynamic preclinical and clinical research into novel drugs addressing unmet medical needs.;

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Drug Discovery and Evaluation: Methods in Clinical Pharmacology

in toxicology. These preclinical methods are described in the second volume Safety and Pharmacokinetic Assays . Only then are first studies in human;

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Alternative Methodologies for the Safety Evaluation of Chemicals in the Cosmetic Industry

First published in 1995: Alternative Methodologies for the Safety Evaluation of Chemicals in the Cosmetic Industry presents a;

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Alternative Methodologies for the Safety Evaluation of Chemicals in the Cosmetic Industry

First published in 1995: Alternative Methodologies for the Safety Evaluation of Chemicals in the Cosmetic Industry presents a;

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Site Evaluation for Nuclear Installations

This Safety Requirements publication takes into account and incorporates developments relating to site evaluation for nuclear installations;

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Glycosylation Engineering of Biopharmaceuticals: Methods and Protocols

Glyco-engineering is being developed as a method to control the composition of carbohydrates and to ;...

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Biopharmaceuticals

, universities, and other R&D organizations to fulfil timely, quality production with perfect safety and security. One of the most interesting aspects;

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Applications of Microdialysis in Pharmaceutical Science

of microdialysis in preclinical and clinical evaluation of drug pharmacology.;

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Genomics in Drug Discovery and Development

. The authors provide a valuable resource for pharmaceutical discovery scientists, preclinical drug safety department personnel, regulatory;

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