Envases de vidrio de uso farmacéutico (guía para el control de calidad)

Envases de vidrio de uso farmacéutico (guía para el control de calidad)
Author: Noralba Sierra Martínez
Publisher: Universidad Nacional de Colombia
Total Pages: 75
Release: 2013-01-01
Genre: Science
ISBN: 958761903X

La calidad de un producto es el resultado de una serie de actividades realizadas durante la elaboración del mismo y exige el cumplimiento de unos requisitos básicos entre los que se encuentran: instalaciones adecuadas, personal capacitado y procedimientos aprobados. Lo anterior, con el fin de llevar a cabo el muestreo, la inspección y el ensayo de materias primas, materiales de envasado y productos intermedios, a granel y acabados. Los materiales de envasado constituyen parte fundamental de los productos farmacéuticos y ejercen un efecto directo sobre su calidad. Por lo tanto, entidades nacionales e internacionales han desarrollado y publicado pruebas o ensayos para verificar la calidad de los mismos, las cuales difieren en las técnicas o metodologías empleadas. En Colombia los requerimientos legales se establecen mediante la Ley 9 de 1979, de la que se desprende el Código Sanitario que en su artículo 448 exige la inocuidad que deben tener los materiales con que se elaboran los envases de uso farmacéutico; de tal forma que, el producto que contiene no debe experimentar ningún tipo de alteración o deterioro.

Natural Ventilation for Infection Control in Health-care Settings

Natural Ventilation for Infection Control in Health-care Settings
Author: Y. Chartier
Publisher: World Health Organization
Total Pages: 132
Release: 2009
Genre: Medical
ISBN: 9241547855

This guideline defines ventilation and then natural ventilation. It explores the design requirements for natural ventilation in the context of infection control, describing the basic principles of design, construction, operation and maintenance for an effective natural ventilation system to control infection in health-care settings.

Cradle to Cradle

Cradle to Cradle
Author: William McDonough
Publisher: North Point Press
Total Pages: 207
Release: 2010-03-01
Genre: Nature
ISBN: 1429973846

A manifesto for a radically different philosophy and practice of manufacture and environmentalism "Reduce, reuse, recycle" urge environmentalists; in other words, do more with less in order to minimize damage. But as this provocative, visionary book argues, this approach perpetuates a one-way, "cradle to grave" manufacturing model that dates to the Industrial Revolution and casts off as much as 90 percent of the materials it uses as waste, much of it toxic. Why not challenge the notion that human industry must inevitably damage the natural world? In fact, why not take nature itself as our model? A tree produces thousands of blossoms in order to create another tree, yet we do not consider its abundance wasteful but safe, beautiful, and highly effective; hence, "waste equals food" is the first principle the book sets forth. Products might be designed so that, after their useful life, they provide nourishment for something new-either as "biological nutrients" that safely re-enter the environment or as "technical nutrients" that circulate within closed-loop industrial cycles, without being "downcycled" into low-grade uses (as most "recyclables" now are). Elaborating their principles from experience (re)designing everything from carpeting to corporate campuses, William McDonough and Michael Braungart make an exciting and viable case for change.

Banana: Genomics and Transgenic Approaches for Genetic Improvement

Banana: Genomics and Transgenic Approaches for Genetic Improvement
Author: Sukhada Mohandas
Publisher: Springer
Total Pages: 345
Release: 2016-09-08
Genre: Science
ISBN: 9811015856

Bananas and plantains are among the most important food and cash crops in the world. They are cultivated in more than 135 countries, across the tropics and subtropics, with an annual global production of ca. 130 million metric tonnes. Though bananas are one of the most important components of food security in many developing countries, banana production is threatened by both abiotic and biotic stresses. These include a wide range of diseases and pests, such as bunchy top virus, burrowing nematodes, black Sigatoka or black leaf streak, Fusarium wilt, etc. In recent years, considerable progress has been made and several biotechnological and genomic tools have been employed to help understand and unravel the mysterious banana genome. Molecular and genomic studies have helped to decipher the Musa genome and its evolution. Genetic linkage map and whole genome sequencing of both Musa acuminata and Musa balbisiana (progenitors of cultivated banana) have completely changed the way of thinking and the approach on banana crop improvement. Whole-genome sequencing has helped to improve the selection of quantitative traits such as yield, as well as the selection of optimal parents for developing required hybrids in breeding programs. Gene isolation and the analysis of mutants have helped in the characterization of genes of agronomic value and the associated regulatory sequences. With the advent of molecular markers and new statistical tools, it is now possible to measure the diversity, identify genes and useful alleles linked to important agronomic traits. Further these alleles can be incorporated into cultivars through marker assisted selection or through transgenic approach. Transgenic approaches are potential tools for direct transfer of these genes into popular cultivars, which are generally not amenable for conventional breeding techniques, in specific with crops such as bananas which are sterile, triploid and heterozygous thereby making it difficult to reconstruct the recurrent genotypes in banana. Transgenic techniques thus have helped overcome the difficulty of working with sterile, triploid banana crop. In the last five years, enormous amount of new information and techniques have been generated for banana. A comprehensive book entitled “Banana: Genomics and Transgenic Approaches for Genetic improvement” on banana genomics, latest transgenic technologies and tools available for improved crop development in banana will address all these requirements.

Guide to the International Registration of Marks under the Madrid Agreement and the Madrid Protocol

Guide to the International Registration of Marks under the Madrid Agreement and the Madrid Protocol
Author: World Intellectual Property Organization
Publisher: WIPO
Total Pages: 191
Release: 2019-09-11
Genre: Law
ISBN: 9280530542

This Guide is primarily intended for applicants and holders of international registrations of marks, as well as officials of the competent administrations of the Member States of the Madrid Union. It leads them through the various steps of the international registration procedure and explains the essential provisions of the Madrid Agreement, the Madrid Protocol and the Common Regulations.

An Introduction to Pharmacovigilance

An Introduction to Pharmacovigilance
Author: Patrick Waller
Publisher: John Wiley & Sons
Total Pages: 194
Release: 2017-05-01
Genre: Medical
ISBN: 1119289742

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. This introductory guide is designed to aid the rapid understanding of the key principles of pharmacovigilance. Packed full of examples illustrating drug safety issues it not only covers the processes involved, but the regulatory aspects and ethical and societal considerations of pharmacovigilance. Covering the basics step-by-step, this book is perfect for beginners and is essential reading for those new to drug safety departments and pharmaceutical medicine students. The second edition is thoroughly revised and updated throughout and includes a new chapter on clinical aspects of pharmacovigilance.

Medicines For Women

Medicines For Women
Author: Mira Harrison-Woolrych
Publisher: Springer
Total Pages: 624
Release: 2015-01-28
Genre: Medical
ISBN: 3319124064

In this definitive new text, the major medicines, devices and vaccines used by women worldwide are brought together for the first time in a single volume. Written and edited by international experts with an evidence-based approach, the book offers a comprehensive summary of all the key areas of women’s medicines. In the first part, issues relating to female drug exposure and considerations for prescribing for subgroups of women - for example during pregnancy and lactation - are presented in the context of contemporary clinical practice. In the second part, specific groups of pharmaceutical products are reviewed, including oral contraceptives, emergency contraception, treatment of chronic pelvic pain, hormone replacement therapy, bisphosphonates, herbal medicines for women, contraceptive devices and human papilloma virus (HPV) vaccines. Every chapter reviews and summarises the efficacy and safety of each group of products and concludes with a useful set of clinical take home messages. In the third part, broader perspectives are presented - from a primary care overview of prescribing for women, through to regulatory, political and religious aspects, including issues with women’s medicines in developing countries. The final two chapters focus on risk communication and conclude that women themselves should be placed at the centre of all discussions about their medicines. The book is aimed at prescribers, other healthcare professionals and students in the field of women’s health throughout the world. It is an extremely valuable resource for all in clinical practice, for students of medicine, nursing, pharmacy and related sciences, and also for those in medicines regulation, pharmacovigilance and the pharmaceutical industry.

Crop Improvement

Crop Improvement
Author: Khalid Rehman Hakeem
Publisher: Springer Science & Business Media
Total Pages: 504
Release: 2013-06-13
Genre: Science
ISBN: 1461470285

The improvement of crop species has been a basic pursuit since cultivation began thousands of years ago. To feed an ever increasing world population will require a great increase in food production. Wheat, corn, rice, potato and few others are expected to lead as the most important crops in the world. Enormous efforts are made all over the world to document as well as use these resources. Everybody knows that the introgression of genes in wheat provided the foundation for the “Green Revolution”. Later also demonstrated the great impact that genetic resources have on production. Several factors are contributing to high plant performance under different environmental conditions, therefore an effective and complementary use of all available technological tools and resources is needed to meet the challenge.

Practical Approaches to Risk Minimisation for Medicinal Products

Practical Approaches to Risk Minimisation for Medicinal Products
Author: World Health Organization
Publisher:
Total Pages: 0
Release: 2014
Genre: Drugs
ISBN: 9789290360841

Risk management of medicines is a wide and rapidly evolving concept and practice, following a medicine throughout its lifecycle, from first administration in humans through clinical studies and then marketing in the patient population at large. Previous reports from CIOMS I - VIII provided practical guidance in some essential components of risk management such as terminology and reporting of adverse drug reactions, management of safety information from clinical trials, and safety signal detection. Beyond the detection, identification, and characterization of risk, "risk minimization" is used as an umbrella term for the prevention or mitigation of an undesirable outcome. Risk management always includes tools for "routine risk minimization" such as product information, the format depending on the jurisdiction, to inform the patient and the prescriber, all of which serve to prevent or mitigate adverse effects. Until this current CIOMS IX document, limited guidance has been available on how to determine which risks need "additional risk minimization," select the appropriate tools, apply and implement such tools globally and locally, and measure if they are effective and valuable. Included in the report is a CIOMS framework for the evaluation of effectiveness of risk minimization, a discussion of future trends and developments, an annex specifically addressing vaccines, and examples from real life.