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Antibody Identification: Art or Science? A Case Study Approach

132020Antibody Identification: Art or Science? A Case Study Approach - Available

ISBN #9781563958373

These cases present serologic problem solving as a series of logical and systematic steps, demonstrating that the art, as well as the science, of antibody identification can be a learned skill.

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Electronic Common Technical Document Templates

139423DBElectronic Common Technical Document Templates

This tool provides user instructions and templates designed for developing Investigational New Drug (IND) and Biologics License Application (BLA) submissions in electronic Common Technical Document (eCTD) structure and format to the US Food and Drug Administration.

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Informed Consent Template

139422DBInformed Consent Template

This tool provides user instructions and a template designed for developing and planning an informed consent document for a clinical trial with investigational cellular therapy product.

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Phase I Clinical Trial Protocol Template

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This tool provides user instructions and a template design for developing and planning a phase 1 clinical trial protocol for an investigational cellular therapy product.

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Pre-IND Meeting Request and Briefing Package Templates

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This tool brings together regulatory information from multiple sources, summarizes the requisite information and provides the necessary templates to schedule a pre-IND meeting with FDA.

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Standards for a Patient Blood Management Program, 1st edition

143186Standards for a Patient Blood Management Program, 1st edition - Available

ISBN #9781563958892

The PBM Standards can help facilities that are implementing or enhancing patient blood management efforts to have a solid foundation for maintaining and optimizing patient care.

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Standards for Blood Banks and Transfusion Services, 29th edition

143120Standards for Blood Banks and Transfusion Services, 29th edition - Available

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The 29th edition details the latest standards of practice in blood banking and transfusion medicine. The quality system requirements are supported by technical requirements.

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Standards for Cellular Therapy Services, 6th edition

133010Standards for Cellular Therapy Services, 6th edition - Available

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The sixth edition of Standards for Cellular Therapy Services details the latest standards of practice for accredited cellular therapy facilities.

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Standards for Immunohematology Reference Laboratories, 8th edition

133125Standards for Immunohematology Reference Laboratories, 8th edition - Available

ISBN #9781563958663

The eighth edition of Standards for Immunohematology Reference Laboratories relies on a matrix of quality management system and detailed operational requirements, such as those defining minimum antisera resources.

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Standards for Perioperative Autologous Blood Collection and Administration, 5th edition and Guidance CD

133100Standards for Perioperative Autologous Blood Collection and Administration, 5th edition and Guidance CD - Available

ISBN #9781563958403

This book contains requirements that address perioperative collection and preparation of red cell and non-red-cell components.

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Standards for Relationship Testing Laboratories, 11th edition and Guidance CD

133110Standards for Relationship Testing Laboratories, 11th edition and Guidance CD - Available

ISBN #9781563958748

Standards for Relationship Testing Laboratories, 11th edition, features new and revised requirements and comes with the Guidance for Standards for Relationship Testing Laboratories on CD-ROM.

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The Transfusion Committee: Putting Patient Safety First, 2nd edition

132075The Transfusion Committee: Putting Patient Safety First, 2nd edition - Available

ISBN #9781563958649

This new edition reflects a significantly increased focus in recent years on patient safety and the economic implications of inappropriate transfusion decisions and transfusion errors. Two new chapters and updates throughout guide hospitals to meet this shift.

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Transfusion Medicine’s Emerging Positions: Transfusion Safety Officers and Patient Blood Management Coordinators

132219Transfusion Medicine’s Emerging Positions: Transfusion Safety Officers and Patient Blood Management Coordinators - Available

ISBN #9781563958700

This book describes the roles and responsibilities of transfusion safety officers and patient blood management coordinators, whether based in a hospital or blood center. Also included is a template for developing a business case to support these positions.

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