Biopharmaceuticals, the term for genetically engineered therapeutic proteins, monoclonal antibodies, and nucleic acid-based products, have become an increasing part of the pharmaceutical armament. While this category of drugs accounts for approximately 25% of all new drugs coming to market, very few references exist that review these commercially available products. Until now, accessing data on the list of currently approved biopharmaceuticals has been laborious and patchy. Directory of Approved Biopharmaceutical Products brings together key information on various aspects of these compounds, presenting a brief summary of each biopharmaceutical currently approved for medical use. Each summary includes the scientific and trade name, year and regions approved, approved indications, manufacturer, marketing right, method of manufacture, scientific overview, and therapeutic properties. Based on information gathered from regulatory agencies and pharmaceutical manufacturers, the book presents the most comprehensive data currently available in a single, convenient volume. This comprehensive and consistent approach will save professionals in the pharmaceutical industry hours spent trawling the literature - and provides a singular resource for future reference.

Carefully crafted to provide tightly focused and authoritative information, the Directory of Therapeutic Enzymes covers all approved therapeutic enzymes currently used in medicine. Written mainly by industry experts, the book includes information sourced directly from the company that developed or manufactured the product. It explores major development issues, from manufacturing and marketing to delivery of the finished product. Chapter 1 reviews applied enzymology while chapter 2 delineates theory and applications. Between them, the first two chapters set the appropriate backdrop for the remaining chapters, which focus on actual enzyme products that have gained regulatory approval for general medical use. The chapter authors discuss the biochemistry of the enzymes, the reactions they catalyze, how they are produced or manufactured, and their medical applications. The book highlights the many applications of approved therapeutic enzymes, including use in the treatment of blood-clotting disorders, certain cancers, and a variety of genetic disorders. Illustrated with tables and figures that support the text, the book is a single source of in-depth technical information.

Hands-on guide through the jungle of medical regulatory affairs for every professional involved in bringing new products to market Based on a module prepared by the authors for an MSc course in Technology Management by Distance Learning offered by the University of Limerick, Ireland, Medical Product Regulatory Affairs is a comprehensive and practical guide on how pharmaceutical and medical devices are regulated within the major global markets. The Second Edition builds on the success of the first with an even wider scope and full coverage of new EU regulations on the safe use of medical devices. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices. Medical Product Regulatory Affairs includes information on: Aims and structure of regulation, covering purpose and principles of regulation, national and EU legislative processes, and pharmacopeia Regulatory strategy, covering product development and manufacturing, market vigilance, quality assurance systems, personnel, and documentation Drug discovery and development, covering prescription status, physical properties, therapeutic use, and drug discovery, development, and delivery Non-clinical studies, covering non-clinical study objectives and timing, pharmacological and pharmacodynamic studies, and bioavailability and bioequivalence Clinical trials, covering trial protocol, monitoring of trials, trial master files, and FDA communications The wide coverage of different product types and the main global markets makes Medical Product Regulatory Affairs ideal for training courses on regulatory affairs in academia and industry. It is also a valuable reference for pharmacologists, bioengineers, pharma engineers, and students in pharmacy to familiarize themselves with the topic.

Why Bodybuilding? You may be reading this and thinking that exact question. First of all lets define bodybuilding for our purposes. Bodybuilding - Any person changing or wishing to change the shape of their body through diet and exercise particularly but not solely through the use of progressive resistance training with weights. This definition covers a huge range of the exercising population from absolute beginner to hard core competitive athletes. Why ? Because all negative connotations aside bodybuilding is the best way to achieve most fitness and body shaping goals. Julie (52) & Gary (55)

A personal trainer in a book for a fraction of the price. Fitness and Physique at any age. Julie and Gary are both over 50 and no signs of ever slowing down. The only rule is that there are no rules. Just a solid belief in it all happening perfectly and the dissolution of any and all negativity. Get rid of the clouds and the sun can shine through.

Why Bodybuilding? You may be reading this and thinking that exact question. First of all lets define bodybuilding for our purposes. Bodybuilding - Any person changing or wishing to change the shape of their body through diet and exercise particularly but not solely through the use of progressive resistance training with weights. This definition covers a huge range of the exercising population from absolute beginner to hard core competitive athletes. Why ? Because all negative connotations aside bodybuilding is the best way to achieve most fitness and body shaping goals.

A personal trainer in a book for a fraction of the price. Fitness and Physique at any age. Julie and Gary are both over 50 and no signs of ever slowing down. The only rule is that there are no rules. Just a solid belief in it all happening perfectly and the dissolution of any and all negativity. Get rid of the clouds and the sun can shine through.

Why Bodybuilding? You may be reading this and thinking that exact question. First of all lets define bodybuilding for our purposes. Bodybuilding - Any person changing or wishing to change the shape of their body through diet and exercise particularly but not solely through the use of progressive resistance training with weights. This definition covers a huge range of the exercising population from absolute beginner to hard core competitive athletes. Why ? Because all negative connotations aside bodybuilding is the best way to achieve most fitness and body shaping goals. Julie and I trained for over 35 years without ever thinking of competing until quite recently. Competitive bodybuilding is an extreme sport. Competitive bodybuilders are just a very small percentage of the total people using bodybuilding techniques to improve their physiques across the world. There is a level for each individual and one can take the sport as a casual pastime to improve health and fitness or to the most extreme levels. Bodybuilding contains the freedom for you to express your individual uniqueness however you choose. However bodybuilders have been turned into quite unsavoury objects by our society and the next feature explains my search for meaning relating to my lifetime of personal bodybuilding choices.

The great mind Michel Foucault considers writing about yourself to be what he terms a technology of the self. Writing being used as a tool to say and discover something about yourself in such a way that you could become different. Forms of personal and private writing bring us close to a type of knowledge that transforms us. Through personal writings about oneself we produce new ways of being. Through the writing a freedom to be a different self is practised. This freedom transforms us and grants us power to pronounce truths about ourselves that may lead others to transform themselves. I write, and will continue to write, in order to reinforce new beliefs and to become different, and by becoming different I practise a transformative freedom, that I hope will lead others to find freedom and change also. A little or a lot. I guess you could say that I agree with Michel Foucault. A great mind that for me has hit the nail on the head. It is my hope within my ramblings that a person will find at least one nugget, hopefully more, that will help give more meaning to the world in which we live. Meaning at the level at which most of us live, on the ground in the real world and not with our heads in the clouds. In this book I will discuss how I try to live my philosophy from day to day. Not even being entirely sure what my philosophy is, and changing daily. Never really succeeding 100% in my aims but being mindful of much that I had never even been aware of previously in my life. The structure will be quite random as that is how life and thoughts arrive with me and how I reflect on them and thus develop my reflections. I have yet to learn how to think in nice ordered chapters. Much is written about the flow of the universe, well I consider that is how I write. An idea presents itself when the time is right. There follows many random thoughts and ideas for you to ingest. First I would like to introduce both myself, my dogs, Julie, my wife and my turbulent past through the introduction and then we will enter the random world of my daily thought processes. It may be thought of as self indulgent to talk about oneself in a book but I hope the following arguments will help state my case. I can only view the world from my unique perspective, attempting anything else would be foolhardy.

It could be argued that men and women are much more the same than they are different. This being said, how and why are the man and woman gender identities constructed so differently? This book will not provide any definitive answers to such complex questions but hopes to provide much food for thought. It may even ultimately lead to a change in thinking and positive changes in gender equality of opportunities. I say equal opportunities as opposed to gender equality as I don't believe any person is ultimately equal to another, we are all so different in so many ways but I do believe the opportunities offered to both genders should be equal. It is all too easy to accept at times that just because a situation is as it is currently that one has no choice. Often the situation has come about by oppression and unequal opportunities and been accepted as the norm over the course of time. The aim of this book is to create some awareness of the less than helpful ideologies and doctrines that have been subtly incorporated into the collective psyche. The healthy situation is that such ideologies and doctrines may be presented and contested and maybe even replaced over time by ideas and behaviours more befitting of a 21st century society

Why Bodybuilding? You may be reading this and thinking that exact question. First of all lets define bodybuilding for our purposes. Bodybuilding - Any person changing or wishing to change the shape of their body through diet and exercise particularly but not solely through the use of progressive resistance training with weights. This definition covers a huge range of the exercising population from absolute beginner to hard core competitive athletes. Why ? Because all negative connotations aside bodybuilding is the best way to achieve most fitness and body shaping goals.

Why Bodybuilding? You may be reading this and thinking that exact question. First of all lets define bodybuilding for our purposes. Bodybuilding - Any person changing or wishing to change the shape of their body through diet and exercise particularly but not solely through the use of progressive resistance training with weights. This definition covers a huge range of the exercising population from absolute beginner to hard core competitive athletes. Why ? Because all negative connotations aside bodybuilding is the best way to achieve most fitness and body shaping goals. Julie and I trained for over 35 years without ever thinking of competing until quite recently. Competitive bodybuilding is an extreme sport. Competitive bodybuilders are just a very small percentage of the total people using bodybuilding techniques to improve their physiques across the world. There is a level for each individual and one can take the sport as a casual pastime to improve health and fitness or to the most extreme levels. Bodybuilding contains the freedom for you to express your individual uniqueness however you choose. Gary (55).

Keeping It Simple Your body is the ultimate gift from Mother Nature, to transport your soul through this life and as such it should be offered much respect. Are you respecting your most precious gift? Can you pass on good habits and respect for your body and health to be a role model for your loved ones? We believe you can, we believe anybody can, you just have to desire the change and the influence will flow on naturally. There has been much written about diet and fitness and as often happens with a popular subject it has become confused and often misleading. Each new expert contradicts the one before and each new diet promises but fails to deliver a "long term" solution to weight management and fitness. This Book is different in as much as all we will do is inform you honestly what has worked and is still working for us and some of the habits that most definitely did not work.

In the 21st century living in the land of plenty as most reading this probably are the temptations leading one away from good feeding habits are many and varied. One is constantly bombarded by the food industry wanting to make a profit with never a thought for any person's health or physique. They want your money. However, congratulations are in order by starting to read this book you have taken a important step towards achieving a leaner, healthier body. You are about to read a cut the crap version of how to eat for maximising your fitness and having optimum energy levels. If you are serious about enhancing your physique and being healthier and fitter all at the same time, you need to know how to feed to meet the tough demands of your Bodymagic training programme and your life. The Fitness Wizards have a combined total of 70 years advising exercisers and personal experience and we know that what, how much and when you feed have a big effect on performance and recovery. Get it right and adopt some good habits and you will have plenty of energy to train and recover from each session ready for the next. Get it wrong and you will be in for a world of pain and simply not keep up the pace. The term overtraining could just as easily be called under feeding or inappropriate feeding. Training, feeding and resting are the big three for progress in any sport or physique enhancing endeavour. Whether it is the Bodymagic Training Programme or any other sport the rules for feeding are the same or similar.

In this auto-ethnographic study I argue and explore the representation of bodybuilders identity and question whether the research is truly representative of bodybuilders or has the research been selective and sensational in dealing with the subject. By looking at current literature and theories on class, identity, and with special attention paid to bodybuilding and masculinity research and studies. Also discussing the way bodybuilders are represented in the literature and comparing to personal experiences and by using Foucault's tools and existentialist philosophy I aim to critically analyse the present, identify and explore oppressive norms and practices that have led to the mis-representation and denigration of bodybuilders, and figure out how to possibly counter those norms and practices. I do so, in part by presenting narratives of self to reveal how competing discourses surround my participation in bodybuilding in a manner that makes it difficult to present a coherent sense of self.

Why bodybuilding for women? You may be reading this and thinking that exact question. First of all lets define bodybuilding for our purposes. Bodybuilding - Any person changing or wishing to change the shape of their body through diet and exercise particularly but not solely through the use of progressive resistance training with weights. This definition covers a huge range of the exercising population from absolute beginner to hard core competitive athletes. Why ? Because all negative connotations aside bodybuilding is the best way to achieve most fitness and body shaping goals.

A personal trainer in a book for a fraction of the price. Fitness and Physique at any age. Julie and Gary are both over 50 and no signs of ever slowing down. The only rule is that there are no rules. Just a solid belief in it all happening perfectly and the dissolution of any and all negativity. Get rid of the clouds and the sun can shine through.

In the twenty-first century and living in the land of plenty, as you probably are if you're reading this book, you have many and varied temptations leading you away from good feeding habits. You are constantly bombarded by the food industry wanting to make a profit with never a thought for your health or physique. They want your money. Your body is your responsibility. However, congratulations are in order. By starting to read this book, you have taken an important step towards achieving a leaner, healthier body. You are about to read a cut-the-crap version of how to eat for maximising your fitness and having optimum energy levels. If you are serious about enhancing your physique and being healthier and fitter all at the same time, you need to know how to feed your body to progress beyond your wildest dreams.

Carefully crafted to provide tightly focused and authoritative information, the Directory of Therapeutic Enzymes covers all approved therapeutic enzymes currently used in medicine. Written mainly by industry experts, the book includes information sourced directly from the company that developed or manufactured the product. It explores major development issues, from manufacturing and marketing to delivery of the finished product.

Chapter 1 reviews applied enzymology while chapter 2 delineates theory and applications. Between them, the first two chapters set the appropriate backdrop for the remaining chapters, which focus on actual enzyme products that have gained regulatory approval for general medical use. The chapter authors discuss the biochemistry of the enzymes, the reactions they catalyze, how they are produced or manufactured, and their medical applications.

The book highlights the many applications of approved therapeutic enzymes, including use in the treatment of blood-clotting disorders, certain cancers, and a variety of genetic disorders. Illustrated with tables and figures that support the text, the book is a single source of in-depth technical information.

Biopharmaceuticals, the term for genetically engineered therapeutic proteins, monoclonal antibodies, and nucleic acid-based products, have become an increasing part of the pharmaceutical armament. While this category of drugs accounts for approximately 25% of all new drugs coming to market, very few references exist that review these commercially available products. Until now, accessing data on the list of currently approved biopharmaceuticals has been laborious and patchy. Directory of Approved Biopharmaceutical Products brings together key information on various aspects of these compounds, presenting a brief summary of each biopharmaceutical currently approved for medical use. Each summary includes the scientific and trade name, year and regions approved, approved indications, manufacturer, marketing right, method of manufacture, scientific overview, and therapeutic properties. Based on information gathered from regulatory agencies and pharmaceutical manufacturers, the book presents the most comprehensive data currently available in a single, convenient volume. This comprehensive and consistent approach will save professionals in the pharmaceutical industry hours spent trawling the literature - and provides a singular resource for future reference.