Australian Official Journal of Patents PDF Download

Author:
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ISBN:
Category : Patents
Languages : en
Pages : 792

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ISBN:
Category : Beryllium
Languages : en
Pages : 298

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Author: World Health Organization
Publisher:
ISBN: 9789290360742
Category : Medical
Languages : en
Pages : 381

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In spite of recent progress in the harmonization of terminology and processes affecting work on the clinical safety of medicines consensus is needed on standards for many difficult aspects of day-to-day pharmacovigilance that continue to pose problems for both the pharmaceutical industry and drug regulators. The CIOMS V Working Group has generated proposals for pragmatic approaches to dealing with such issues as: classification and handling of individual safety case reports from a variety of sources (spontaneous consumer reports solicited reports literature the Internet observational studies and secondary data bases disease and other registries regulatory ADR databases and licensor-licensee interactions); new approaches to case management and regulatory reporting practices (proper clinical evaluation of cases incidental vs other events patient and reporter identifiability seriousness criteria expectedness criteria case follow-up criteria and the role and structure of case narratives); improvements and efficiencies in the format content and reporting of periodic safety update reports (PSURs) (including results of an industry survey on PSUR workloads and practices; proposals for high case volume and long time-period reports simplification of certain PSURs summary bridging reports addendum reports license renewal reports for EU and Japan dealing with old products and other technical details); determination and use of population exposure (denominator) data (sources of data and a guide to analytical approaches for a variety of circumstances).The Group has also taken stock of the current state of expedited and periodic clinical safety reporting requirements around the world with summary data on regulations from more than 60 countries. Recommendations are made for enhancing the harmonization steps already taken as a result of previous CIOMS publications and the ICH process. In addition to dealing with unfinished and unresolved issues from previous CIOMS initiatives the report covers many emerging topics such as those involving new technologies. Its 20 Appendices provide a wealth of detailed explanations and reference information. It is the most comprehensive and recent treatment of difficult pharmacovigilance issues affecting the working practices and systems of drug safety and other pharmaceutical professionals.

Author: Heinrich Klefenz
Publisher: Wiley-VCH
ISBN:
Category : Medical
Languages : de
Pages : 328

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This volume focuses on pharmaceutical biotechnology as a key area of life sciences. The complete range of concepts, processes and technologies of biotechnology is applied in modern industrial pharmaceutical research, development and production. The results of genome sequencing and studies of biological-genetic function are combined with chemical, micro-electronic and microsystem technology to produce medical devices and diagnostic biochips. A multitude of biologically active molecules is expanded by additional novel structures created with newly arranged gene clusters and bio-catalytic chemical processes. New organisational structures in the co-operation of institutes, companies and networks enable faster knowledge and product development and immediate application of the results of research and process development. This book is the ideal source of information for scientists and engineers in research and development, for decision-makers in biotech, pharma and chemical corporations, as well as for research institutes, but also for founders of biotech companies and people working for venture capital corporations.

Author: International Atomic Energy Agency
Publisher:
ISBN: 9789201078070
Category : Ion bombardment
Languages : en
Pages : 0

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This publication covers all the aspects of the relative biological effectiveness (RBE) of ion beams, including laboratory measurements of RBE and the important variables that influence it, dose related quantities and units, and approaches to the clinical use of the concept of RBE based on experimental findings, theoretical models, and previous clinical experience with fast neutrons and ions. This publication is the result of a joint initiative of the IAEA and ICRU (International Commission on Radiation Units and Measurements). It is the only current extensive review of ion beam RBE, and it is expected to be a reference volume for existing and future centres employing ion beams for therapeutic use.

Author: Steven E. Schild, MD
Publisher: Demos Medical Publishing
ISBN: 1935281801
Category : Medical
Languages : en
Pages : 260

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Thoracic Malignancies: Thoracic Malignancies is the first title in Radiation Medicine Rounds. These tumors take more lives than any others and they are among the most preventable of tumors. Thus it is crucial for the practitioner to be up-to-date on the latest insights regarding their management. Thoracic Malignancies addresses the multi-disciplinary nature of the care of these tumors. There is representation from radiation oncology, medical oncology, and surgery ensuring a well-rounded summarization of current practice. Included are chapters on lung cancer, esophageal cancer, and thymomas providing coverage of the vast majority of thoracic tumors. The multi-disciplinary nature of the articles provides readers with an up-to-date summary and a well-rounded review regarding these tumors and their care. Expert authors provide reviews and assessments of the most recent data and its implications for current clinical practice, along with insights into emerging new trends of importance for the near future. About the Series Radiation Medicine Rounds is an invited review publication providing a thorough analysis of new scientific, technologic, and clinical advances in all areas of radiation medicine. There is an emphasis throughout on multidisciplinary approaches to the specialty, as well as on quality and outcomes analysis. Published three times a year Radiation Medicine Rounds provides authoritative, thorough assessments of a wide range of Ïhot topicsÓ and emerging new data for the entire specialty of radiation medicine. Features of Radiation Medicine Rounds include: Editorial board of nationally recognized experts across the spectrum of radiation medicine In-depth, up-to-date expert reviews and analysis of major new developments in all areas of Radiation Medicine Issues edited by an authority in specific subject area Focuses on major topics in Radiation Medicine with in-depth articles covering advances in radiation science radiation medicine technology, radiation medicine practice, and assessment of recent quality and outcomes studies Emphasizes multidisciplinary approaches to research and practice

Author: Ariff Bongso
Publisher: World Scientific
ISBN: 9814289388
Category : Science
Languages : en
Pages : 721

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Stem cell biology has drawn tremendous interest in recent years as it promises cures for a variety of incurable diseases. This book deals with the basic and clinical aspects of stem cell research and involves work on the full spectrum of stem cells isolated today. It also covers the conversion of stem cell types into a variety of useful tissues which may be used in the future for transplantation therapy. It is thus aimed at undergraduates, postgraduates, scientists, embryologists, doctors, tissue engineers and anyone who wishes to gain some insight into stem cell biology. This book is important as it is comprehensive and covers all aspects of stem cell biology, from basic research to clinical applications. It will have 33 chapters written by renowned stem cell scientists worldwide. It will be up-to-date and all the chapters include self-explanatory figures, color photographs, graphics and tables. It will be easy to read and give the reader a complete understanding and state of the art of the exciting science and its applications.

Author:
Publisher:
ISBN: 9789201210197
Category : Radioisotopes
Languages : en
Pages : 301

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"A key requirement for the effective implementation of the therapeutic approach, based on the intravenous administration of radiolabelled compounds (radionuclide therapy), is the sufficient availability of radionuclides with appropriate physical characteristics. Based on their nuclear properties, 188Re and 90Y are considered among the most interesting radionuclides for therapy. Furthermore, they are produced through portable generators, which provide a crucial advantage toward ensuring a worldwide distribution of these radionuclides. This publication illustrates recent studies aimed at investigating efficient quality control methods to ensure both the radionuclidic purity of generator eluates, and the proper preparation of new target specific 188Re and 90Y radiopharmaceuticals for various clinical applications."--Publisher's description.

Author: Marc Damelin
Publisher: Springer
ISBN: 3319781545
Category : Medical
Languages : en
Pages : 358

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Antibody-drug conjugates (ADCs) stand at the verge of a transformation. Scores of clinical programs have yielded only a few regulatory approvals, but a wave of technological innovation now empowers us to overcome past technical challenges. This volume focuses on the next generation of ADCs and the innovations that will enable them. The book inspires the future by integrating the field’s history with novel strategies and cutting-edge technologies. While the book primarily addresses ADCs for solid tumors, the last chapter explores the emerging interest in using ADCs to treat other diseases. The therapeutic rationale of ADCs is strong: to direct small molecules to the desired site of action (and away from normal tissues) by conjugation to antibodies or other targeting moieties. However, the combination of small and large molecules imposes deep complexity to lead optimization, pharmacokinetics, toxicology, analytics and manufacturing. The field has made significant advances in all of these areas by improving target selection, ADC design, manufacturing methods and clinical strategies. These innovations will inspire and educate scientists who are designing next-generation ADCs with the potential to transform the lives of patients.

Author:
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 1336

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