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  • 1
    Keywords: Pharmaceutical technology ; Pharmacy ; Pharmaceutical Sciences/Technology ; Pharmacy ; Springer eBooks
    Description / Table of Contents: Recombinant DNA Technology -- Therapeutic Proteins -- Therapeutic Antibodies -- Analysis and Regulation of Biologics including Biosimilars
    Abstract: The purpose of this book is to give a concise introduction to development and analysis of pharmaceutical biologics for those in the pharmaceutical industry who are switching focus from small molecules to biologics processing, analysis, and delivery. In order to maintain a limited focus, Introduction to Biologic and Biosimilar Product Development and Analysis, will deal only with peptides, proteins and monoclonal antibodies
    Pages: XI, 109 p. 4 illus. in color. : online resource.
    ISBN: 9783319984285
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  • 2
    Keywords: Pharmaceutical technology ; Pharmacy ; Pharmaceutical Sciences/Technology ; Pharmacy ; Springer eBooks
    Description / Table of Contents: Volume One.Preface -- Lifestyle Approach to Validation -- Solid Dose Formulations -- Stage 1A Process Design: Quality by Design -- Knowledge Management and Risk Assessment for Lifestyle Stages -- .Stage 1B Process and Scale Up Considerations -- Stage 2A and 2B Process Qualifications -- Stage 3A and 3B: Continued Process Verification
    Abstract: Currently there are no process validation (PV) textbooks addressing the lifecycle concepts (Stage 1, 2, 3). Recent regulatory guidance's such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. The concepts are now harmonized across regulatory guidance's and organizations have an opportunity to align PV activities for all regulated markets. Therefore a need exists for consensus and direction on how to approach solid dose manufacturing process validation for regulatory compliance. Solid Dose Process Validation: The Basics, Volume One and companion Solid Dose Process Validation: Lifecycle Approach Application, Volume Two, also available as a set, provide directions and solutions for these unmet needs for the pharmaceutical industry. The topics and chapters give a systematic understanding for the application of lifecycle concepts in solid dose pharmaceutical manufacturing. All approaches meet the regulatory requirements enlisted in the guidance’s, which is the precursor to applying the concepts. This set is published as a comprehensive solution for solid dose process validation. Since solid dose formulations encompass majority of the pharmaceutical preparations, it is essential information for pharmaceutical professionals who use the process validation lifecycle approach
    Pages: XIV, 92 p. 54 illus., 37 illus. in color. : online resource.
    ISBN: 9783030024727
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  • 3
    Keywords: Pharmaceutical technology ; Pharmacy ; Pharmaceutical Sciences/Technology ; Pharmacy ; Springer eBooks
    Description / Table of Contents: Preface:Designing a Flipped-Classroom Pharmaceutics Course -- Guide to Patent and Literature Searching in Pharmaceutics -- Preformulation -- Capsules and Tablets -- Modified Release Solid Oral Dosage Forms -- Solution-Based Dosage Forms and Sterile Products -- Suspensions -- Emulsions -- Ophthalmic Delivery -- Nasal Dosage Forms -- Topical and Transdermal Dosage Forms -- Suppositories and Inserts -- Pulmonary Drug Delivery -- Regulations in Drug Product Development
    Abstract: Particularly in healthcare fields, there is growing movement away from traditional lecture style course towards active learning and team-based activities to improve learning and build higher level thinking through application of complex problems with a strong foundation of facts and data. Essential Pharmaceutics is suited to this modern teaching style, and is the first book of its kind to provide the resources and skills needed for successful implementation of an active learning pharmaceutics course.This text offers a format that is specifically suited for integration in an active learning, team-based classroom setting. It is ideal for self-learning for the beginning pharmaceutics student, based upon the extensive utilization of figures, tables, and its overview of essential topics in pharmaceutics. Also unique to this text is the integration of case studies based upon modern pharmaceutical products which are designed to reinforce importance pharmaceutical concepts and teach essential skills in literature review and patent searching. Case studies covering all topics covered in the text have been developed by the authors that allow application of the content in the flipped-classroom pharmaceutical course
    Pages: X, 193 p. 65 illus., 56 illus. in color. : online resource.
    Edition: 1st ed. 2019.
    ISBN: 9783030317454
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