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The International Pharmacopoeia

Author: World Health Organization

Publisher: World Health Organization

Published: 2006

Total Pages: 1526

ISBN-13: 924156301X

The International Pharmacopoeia contains a collection of recommended methods for analysis and quality specifications for pharmaceutical substances, excipients and products. This new edition consolidates the texts of the five separate volumes of the third edition and includes new monographs for antiretroviral substances (didanosine, indinavir sulfate, nelfinavir mesilate, nevirapine, ritonavir, saquinovir, and saquinovir mesilate) adopted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations in October 2004. It includes some additions and amendments to the general notices of the Pharmacopoeia, as well as some changes to its layout and format. Volume one contains monographs for pharmaceutical substances A to O and the General Notices; and volume two contains monographs for pharmaceutical substances P to Z, together with those for dosage forms and radiopharmaceutical preparations, the methods of analysis and reagents.

Obesity

Author: World Health Organization

Publisher: World Health Organization

Published: 2000

Total Pages: 267

ISBN-13: 9241208945

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This report issues a call for urgent action to combat the growing epidemic of obesity, which now affects developing and industrialized countries alike. Adopting a public health approach, the report responds to both the enormity of health problems associated with obesity and the notorious difficulty of treating this complex, multifactorial disease. With these problems in mind, the report aims to help policy-makers introduce strategies for prevention and management that have the greatest chance of success. The importance of prevention as the most sensible strategy in developing countries, where obesity coexists with undernutrition, is repeatedly emphasized. Recommended lines of action, which reflect the consensus reached by 25 leading authorities, are based on a critical review of current scientific knowledge about the causes of obesity in both individuals and populations. While all causes are considered, major attention is given to behavioural and societal changes that have increased the energy density of diets, overwhelmed sophisticated regulatory systems that control appetite and maintain energy balance, and reduced physical activity. Specific topics discussed range from the importance of fat content in the food supply as a cause of population-wide obesity, through misconceptions about obesity held by both the medical profession and the public, to strategies for dealing with the alarming prevalence of obesity in children. "... the volume is clearly written, and carries a wealth of summary information that is likely to be invaluable for anyone interested in the public health aspects of obesity and fatness, be they students, practitioner or researcher." - Journal of Biosocial Science

WHO Expert Committee on Biological Standardization

Author: World Health Organization. Expert Committee on Biological Standardization

Publisher: World Health Organization

Published: 2015-06-30

Total Pages: 282

ISBN-13: 9241209933

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This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of vaccines and other biological substances and the establishment of international biological reference materials. Following a brief introduction the report summarizes a number of general issues brought to the attention of the Committee. The next part of the report of particular relevance to manufacturers and national regulatory authorities outlines the discussions held on the development and adoption of new and revised WHO Recommendations Guidelines and guidance documents. Following these discussions a WHO guidance document on the Scientific principles for regulatory risk evaluation on finding an adventitious agent in a marketed vaccine was adopted along with WHO Guidelines on procedures and data requirements for changes to approved vaccines and revised WHO Recommendations to assure the quality safety and efficacy of poliomyelitis vaccines (inactivated). Subsequent sections of the report provide information on the current status and proposed development of international reference materials in the areas of antibiotics; biotherapeutics other than blood products; blood products and related substances; in vitro diagnostic device reagents; and vaccines and related substances. A series of annexes are then presented which include an updated list of all WHO Recommendations Guidelines and other documents on biological substances used in medicine (Annex 1). The above three WHO documents adopted on the advice of the Committee are then published as part of this report (Annexes 2–4). Finally all additions and discontinuations made during the 2014 meeting to the list of International Standards Reference Reagents and Reference Panels for biological substances maintained by WHO are summarized in Annex 5. The updated full catalogue of WHO International Reference Preparations is available at: http://www.who.int/bloodproducts/catalogue/en/.

WHO Expert Committee on Specifications for Pharmaceutical Preparations

Author: World Health Organization

Publisher: World Health Organization

Published: 2019-05-29

Total Pages: 303

ISBN-13: 9241210281

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The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensusbuilding process. The following new guidelines were adopted and recommended for use: Procedure for development of the WHO medicines quality assurance guidelines; Guidelines on Good Manufacturing Practices (GMP) for heating ventilation and air-conditioning systems (HVAC) ? illustrative part; Guidance on GMP for Validation including the general main text analytical procedure validation validation of computerized systems and qualification; in the area of interchangeability of multisource medicines: the Protocol to conduct equilibrium solubility experiments for the purpose of biopharmaceutics classification systembased classification of active pharmaceutical ingredients for biowaiver; Guidelines on Import Procedures for pharmaceutical products; and the Good Practice Guidance document on implementing the collaborative procedures. All of the above are included in this report and recommended for implementation.