Reports of Cases in the Supreme Court of Nebraska PDF Download

Author: Nebraska. Supreme Court
Publisher:
ISBN:
Category : Court rules
Languages : en
Pages : 932

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Book Description
"Rules of the supreme court. In force February 1, 1914": v. 94, p. vii-xx.

Author:
Publisher:
ISBN:
Category : Code of federal regulations
Languages : en
Pages : 120

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Author:
Publisher:
ISBN:
Category : Accreditation (Education)
Languages : en
Pages : 214

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Author: Lindsay Falvey
Publisher: ILRI (aka ILCA and ILRAD)
ISBN: 9780734014320
Category : Agricultural systems
Languages : en
Pages : 466

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Author: John Geigert
Publisher: Springer
ISBN: 3030137546
Category : Medical
Languages : en
Pages : 446

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Book Description
Biopharmaceuticals (i.e., biological medicines sourced from genetically-engineered living systems) for treatment of human diseases have become a significant percentage of the pharmaceutical industry. And not just the recombinant DNA-derived proteins and monoclonal antibodies (both from the innovators and biosimilars); but now, an increasing awareness of the importance of gene therapy and genetically engineered cellular medicinal products. These biopharmaceuticals are being developed by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the CMC strategy and regulatory compliance requirements for these challenging products. Companies clearly plan out the strategy for their clinical study plans, but frequently, the development of a strategy for CMC is an afterthought. Coupled with the complexity of the biopharmaceutical manufacturing processes and products, and this can be a recipe for disaster. The third edition of this book provides insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for all biopharmaceuticals (recombinant proteins, monoclonal antibodies, genetically engineered viruses and genetically engineered human cells) from early clinical stage development through market approval. The third edition of this book provides added coverage for the biosimilars, antibody drug conjugates (ADCs), bispecific antibodies, genetically engineered viruses, and genetically engineered cells. This third edition of the book also addresses the heightened pressure on CMC regulatory compliance timelines due to the introduction of expedited clinical pathways moving the clinical development closer to a seamless phase process (e.g., FDA Breakthrough Therapy designation, CBER Regenerative Medicine Advanced Therapy (RMAT) designation, EMA Priority Medicines (PRIME) designation). The Challenge of CMC Regulatory Compliance for Biopharmaceuticals is essential, practical information for all pharmaceutical development scientists, Manufacturing and Quality Unit staff, Regulatory Affairs personnel, and senior management involved in the manufacture of biopharmaceuticals.

Author: Glyn N. Stacey
Publisher: John Wiley & Sons
ISBN: 9780470723784
Category : Science
Languages : en
Pages : 696

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Book Description
Medicines from Animal Cell Culture focuses on the use of animal cell culture, which has been used to produce human and veterinary vaccines, interferon, monoclonal antibodies and genetically engineered products such as tPA and erythropoietin. It also addresses the recent dramatic expansion in cell-based therapies, including the use of live cells for tissue regeneration and the culture of stem cells. Medicines from Animal Cell Culture: Provides comprehensive descriptions of methods for cell culture and nutrition as well as the technologies for the preservation and characterisation of both the cells and the derived products Describes the preparation of stem cells and others for use in cell-based therapies – an area of burgeoning research Includes experimental examples to indicate expected results Covers regulatory issues from the UK, the EU and the USA and reviews how these are developing around the world Addresses the key issues of standardisation and validation with chapters on GLP and GMP for cell culture processes Delivering insight into the exciting world of biological medicines and directions for further investigation into specific topics, Medicines from Animal Cell Culture is an essential resource for researchers and technicians at all levels using cell culture within the pharmaceutical, biotechnology and biomedical industries. It is of value to laboratory managers in these industries and to all those interested in this topic alike.

Author: David L. Meeker
Publisher:
ISBN: 9780965466035
Category : Animal industry
Languages : en
Pages : 302

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Book Description

Author: Dorland
Publisher: Elsevier Health Sciences
ISBN: 0323442544
Category : Medical
Languages : en
Pages : 481

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Book Description
Medical acronyms and abbreviations offer convenience, but those countless shortcuts can often be confusing. Now a part of the popular Dorland's suite of products, this reference features thousands of terms from across various medical specialties. Its alphabetical arrangement makes for quick reference, and expanded coverage of symbols ensures they are easier to find. Effective communication plays an important role in all medical settings, so turn to this trusted volume for nearly any medical abbreviation you might encounter. - Symbols section makes it easier to locate unusual or seldom-used symbols. - Convenient alphabetical format allows you to find the entry you need more intuitively. - More than 90,000 entries and definitions. - Many new and updated entries including terminology in expanding specialties, such as Nursing; Physical, Occupational, and Speech Therapies; Transcription and Coding; Computer and Technical Fields. - New section on abbreviations to avoid, including Joint Commission abbreviations that are not to be used. - Incorporates updates suggested by the Institute for Safe Medication Practices (ISMP).

Author: Rhode Island. State nursery inspector
Publisher:
ISBN:
Category : Beneficial insects
Languages : en
Pages : 230

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Book Description

Author: Yashpal Singh Malik
Publisher: Springer Nature
ISBN: 9811526516
Category : Medical
Languages : en
Pages : 386

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Book Description
This book is the second volume in the series Livestock Diseases and Management, and reviews the importance and implications of animal origin viral zoonoses. It also highlights the specific etiology and epidemiology of these viral infections and discusses their various biological and mechanical transmission mechanisms. Further, the book reviews various measures for controlling viral zoonoses and examines novel therapeutic and prophylactic strategies. Discussing recent studies on the pathogenesis and host immune response to these infections, it underscores the importance of using vaccines against these viral diseases to reduce the risk of them being transmitted to humans.Lastly, it describes in detail the challenges posed by these viral infections and our readiness to face them.