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Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics

This book describes the authors' standard or 'best' practices used in writing regul- ed clinical documents for the drug and biologics;

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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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Rational Therapeutics for Infants and Children

, and was entitled Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making. The summary on that workshop;

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Adme And Translational Pharmacokinetics / Pharmacodynamics O

, ADCs, bispecifics, and vaccines Presents regulatory expectations and industry perspectives for developing biologic drugs in USA, EU, and Japan;

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Biological Drug Products

This book overviews the fundamental aspects, challenges, and strategies for developing a variety of biological drugs -- a large and growing;

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Biologics in General Medicine

currently approved for clinical use are delineated in a standardized way, but also the differential therapy with biologics in fields including;

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Biologics, Biosimilars, and Biobetters

behind biologics, biosimilars, and biobetters from a practical and clinical perspective. Explains what pharmacists need to discuss the;

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Drug Delivery Aspects

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

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Analytical Techniques for Clinical Chemistry

techniques. The book opens with an overview of the regulatory framework around clinical lab analysis and then details applications including;

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Translating Biomaterials for Bone Graft

tissue engineering, from design to application - from materials, drugs and biologic delivery used for bone graft applications to pre-clinical and;

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Translating Biomaterials for Bone Graft

tissue engineering, from design to application - from materials, drugs and biologic delivery used for bone graft applications to pre-clinical and;

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Delivery of Drugs

of drug delivery carriers, such as clinical, engineering, and regulatory, facilitate insight sharing across expertise area and form a link for;

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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

the strategic importance and value generated by QA/QC for their involvement in control of manufacturing. It will put into perspective the need;

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Biosimilar and Interchangeable Biologics

need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an;

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Safe and Effective Medicines for Children

The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric;

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Follow-On Biologics

framework at the FDA, the scientific challenges for the FDA in considering the approval of follow-on biologics, and a brief description of the;

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Safety of Biologics Therapy

of mechanisms of action, Indications for therapy, immunogenicity and a detailed examination of adverse effects and safety of the many and diverse;

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Drug Delivery Strategies for Poorly Water-Soluble Drugs

formulation strategies for a wide range of hydrophobic drugs. With a focus on critical formulation features and clinical studies, the book covers;

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Safety of Biologics Therapy: Monoclonal Antibodies, Cytokines, Fusion Proteins, Hormones, Enzymes, Coagulation Proteins, Vaccines, Botulinum Toxins

of mechanisms of action, Indications for therapy, immunogenicity and a detailed examination of adverse effects and safety of the many and diverse;

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Biosimilars and Interchangeable Biologics

in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall;

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Biosimilars and Interchangeable Biologics

in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall;

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Drug-Drug Interactions for Therapeutic Biologics

in drug response of the co-administered drugs. Using illustrative case studies and examples, Drug-Drug Interactions for Therapeutic Biologics;

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Clinical Perspectives and Targeted Therapies in Apoptosis

Clinical Perspectives and Targeted Therapies in Apoptosis: Drug Discovery, Drug Delivery, and Disease Prevention provides comprehensive;

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Topical Drug Bioavailability, Bioequivalence, and Penetration

This authoritative volume explores advances in the techniques used to measure percutaneous penetration of drugs and chemicals to assess;

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Identification and Quantification of Drugs, Metabolites, Drug Metabolizing Enzymes, and Transporters

sections in the book with 24 chapters give readers an overview of state-of-the-art techniques for identifying and quantifying drugs, metabolites;

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New Skin Toxicities for New Anticancer Therapies

Targeted cancer therapies have revolutionised the therapeutic management of many neoplasms, modifying patients' prognosis and overall;

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Current Trends in Monoclonal Antibody Development and Manufacturing

. Recently the regulatory review of monoclonal antibodies has been moved from Center for Biologics and Research to the Center for Drug Evaluation and;

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