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Development and Approval of Combination Products

combination drug development, this book guides you step by step through all the preclinical, clinical, and manufacturing stages. Written from an FDA;

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Biosimilar Drug Product Development

. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and;

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Sustained-Release Injectable Products

administration routes. From the rationale and basic product development principles to regulatory issues and the approval process, expert contributions;

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New Drug Approval Process

pharmaceutical product approval and influence how new products are researched and marketed. Updated chapters include: advances;

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Sustained-Release Injectable Products

administration routes. From the rationale and basic product development principles to regulatory issues and the approval process, expert contributions;

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Analytical Similarity Assessment in Biosimilar Product Development

, current issues, and recent developments in analytical similarity assessment.;

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Analytical Similarity Assessment in Biosimilar Product Development

, current issues, and recent developments in analytical similarity assessment.;

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Assurance of Sterility for Sensitive Combination Products and Materials

Assurance of Sterility for Sensitive Combination Products and Materials: New Paradigms for the Next Generation of Medical Devices and;

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Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition

and regulatory concerns. Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition presents in-depth discussions from more;

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Pharmaceutical Dosage Forms

pharmaceutical excipients. It explains the requirements for conducting clinical research and obtaining marketing approval for new drug products;

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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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Biosimilars

of research and development of biological products.;

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Biosimilars

of research and development of biological products.;

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Dermal Drug Delivery

present objectively a balanced view of the current state of these products development and commercialization via regulatory approval. Their;

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Dermal Drug Delivery

present objectively a balanced view of the current state of these products development and commercialization via regulatory approval. Their;

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US Medical Drugs Development, Approval Process and Regulations Handbook Volume 1 Strategic, Practical Information and Regulations

US Medical Drugs Development, Approval Process and Regulations Handbook Volume 1 Strategic, Practical Information and Regulations;

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Lean Customer Development Building Products Your Customers Will Buy

through customer development research-before you waste months and millions on a product or service that no one needs or wants. With a;

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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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Preparing for FDA Pre-Approval Inspections

evidenced by a systems-based approach to inspections demonstrates what each area of pharmaceutical development, from research and development to;

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Competing by Design

. Demonstrates how to take advantage of the latest development tools and product design, use such proven techniques as robust design and QFD and assess;

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Mesenchymal Stromal Cells

the clinic and building on the biology and mechanisms of action, this unique book covers the development and production clinical-grade;

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Drug-device Combinations for Chronic Diseases

This book covers two areas, the first detailing the concepts and technologies of drug-device combination products. The second area includes;

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International Labeling Requirements for Medical Devices, Medical Equipment and Diagnostic Products

Completely revised, this second edition provides the practical, hands-on labeling information needed to secure rapid regulatory approval;

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International Labeling Requirements for Medical Devices, Medical Equipment and Diagnostic Products

Completely revised, this second edition provides the practical, hands-on labeling information needed to secure rapid regulatory approval;

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Safety Evaluation in the Development of Medical Devices and Combination Products

, incorporating combination products and helpful case examples of current real-life problems in the field. The Third Edition explores these key current;

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Toxicological Effects of Veterinary Medicinal Products in Humans

approval and what measures can be taken after authorisationapproval in the light of findings from pharmacovigilance activities. There is growing;

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