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Malik Osmane: Rift-Lines Within European Regulatory Framework for Biosimilars When Taking Heterogeneity and Variation During Lifecycle of the Reference Biologic and the Biosimilar Into Account

Description

Biopharmaceutical medicinal products (biologics) represent a huge financial market. Thus upon patent protection expiry of the innovator (reference) biologic there is interest from industry to gain a portion of this market by launching a 'similar' biologic at a reduced development cost, thus boosting potential gains. The EMA responded to this desire and lead the guidance process with industry on the topic of biosimilars. Based on the experience gained with biosimilars in the past, the EMA started to introduce a second generation series of guidance documents, which take into account the past, current and possibly future challenges of biosimilars. Those proposals were evaluated by EMA and partially incorporated into new guidance documents. This work highlights the challenges and risks associated with biosimilar submissions for large and complex bio-molecules such antibodies. Results: There are unaddressed questions for the regulator with regard to the unsolved dynamic of heterogeneity and variations of the quality profile, which have potential implications on safety and efficacy. This is neglected and not taken into account seriously enough by the stakeholders. Solution: Further, the only (in my view) progressive way to deal with such foreseeable situations from the biosimilar developer's point of view is to incorporate a design space.

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Jared Cooney Horvath,Jason M. Lodge,John Hattie: From the Laboratory to the Classroom: Translating Science of Learning for Teachers

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Over recent years the field of educational neuroscience has increased dramatically. Unfortunately, despite claims that this work is impacting education, very little makes it into teacher practice. Although the reasons for this are varied, a primary one concerns the lack of a proper translation framework. From the Laboratory to the Classroom gathers an international team of experts and is the first book to present a coherent framework for the vital translation of laboratory research for educational practice. This field shifting work will apply this framework to a number of different educational domains and suggest concrete ways to apply current scientific findings to everyday practice.

Adaptable to both studio and lecture courses and appropriate for all student levels from beginner to advanced, The New Munsell Student Color Set, 3rd Edition, is a genuine learning aid that offers opportunities for experimenting with color effects using paint, paper, and computers. A full-color interactive and experimental guidebook for understanding color in all its dimensions, it includes 11 Munsell color charts, 15 interactive charts, 14 packets of color chips, and a textbook, all designed to facilitate hands-on learning of color's aspects and effects. The text provides a complete study of color use and color science, including extended discussion of visual perception, optical effects, and practical application of color phenomena in fine and applied art practices. Buttercream is the lightest, fluffiest icing, simply made by beating together icing sugar and butter. When meringue is added, it is known as Swiss Style buttercream and is the icing choice for professional and home bakers too, because of its thick and luscious consistency - perfect for decorating cakes and cupcakes. The wholesome and delicious quality of buttercream is exemplified in these recipes that Carey Madden shares from her years of professional baking Transformers: Volume 7: Combiner Wars--First Strike pdf and decorating experience. The Getting Started section includes photos, descriptions and uses of decorating tools to her fail-safe recipes for cakes, cupcakes and icings. Then the 500 step-by-step colour photos for every recipe technique enhance her clear and easy-to-follow decorating concepts and techniques. There are 10 sumptuous 'foundation' cake and cupcake recipes for chocolate, vanilla, red velvet, carrot, pink velvet, chocolate courgette, gluten-free chocolate, gluten-free blueberry lavender, vegan spice and sugar-free banana cake.

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Andrew Griffith,Livio Ramondelli,Sarah Stone,John Barber: Transformers: Volume 7: Combiner Wars--First Strike

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* Wheeljack awakens to find a strange, new Cybertron! The secret origins of Cybertron's golden age are revealed to Optimus Prime - and what he learns changes everything about the Autobots' mission on Earth as all-out war erupts on the streets of Tokyo. * Collects issues #33-38.

Adaptable to both studio and lecture courses and appropriate for all student levels from beginner to advanced, The New Munsell Student Color Set, 3rd Edition, is a genuine learning aid that offers opportunities for experimenting with color effects using paint, paper, and computers. A full-color interactive and experimental guidebook for understanding color in all its dimensions, it includes 11 Munsell color charts, 15 interactive charts, 14 packets of color chips, and a textbook, all designed to facilitate hands-on learning of color's aspects and effects. The text provides a complete study of color use and color science, including extended discussion of visual perception, optical effects, and practical application of color phenomena in fine and applied art practices. Buttercream is the lightest, fluffiest icing, simply made by beating together icing sugar and butter. When meringue is added, it is known as Swiss Style buttercream and is the icing choice for professional and home bakers too, because of its thick and luscious consistency - perfect for decorating cakes and cupcakes. The wholesome and delicious quality of buttercream is exemplified in these recipes that Carey Madden shares from her years of professional baking Transformers: Volume 7: Combiner Wars--First Strike pdf and decorating experience. The Getting Started section includes photos, descriptions and uses of decorating tools to her fail-safe recipes for cakes, cupcakes and icings. Then the 500 step-by-step colour photos for every recipe technique enhance her clear and easy-to-follow decorating concepts and techniques. There are 10 sumptuous 'foundation' cake and cupcake recipes for chocolate, vanilla, red velvet, carrot, pink velvet, chocolate courgette, gluten-free chocolate, gluten-free blueberry lavender, vegan spice and sugar-free banana cake.

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Ellen Hasbrouck: Planets: a Solar System Stickerbook

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Take a trip through the solar system and discover what s really up in the sky! Packed with fascinating facts about planets, comets, asteroids and more, "Planets" is a galaxy of fun for young astronomers...and everybody who gazes at the night sky! Create your own universe and solar system with reusable stickers of the planets, asteroids, galaxies, and comets!"

Have you ever tried to explain the rules of football to someone from another culture? Or to a friend who doesn't understand sport? Now imagine trying to explain if both teams were wearing the same colours - or everyone wore different ones. Or if they all wore blindfolds - how could you explain that? Relationships can be as baffling as playing a game blindfolded. The stakes are high: losses can be disastrous but winning can lead to a lifetime of happiness. And you can't play the game - let alone win it - if you don't know the rules. In this book, Dr Irene Alexander explores what makes relationships work, covering everything from boundaries to sex. The essence is learning how to relate openly and effectively. When you achieve this, even conflict can Planets: a Solar System Stickerbook download PDF be constructive and relationships will take on new depth and satisfying fullness.

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George Gershwin,Maurice Hinson: Gershwin: Complete Works for Solo Piano

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Editor Maurice Hinson has compiled this outstanding collection of George Gershwin's complete works for solo piano. Includes performance notes and helpful editorial pedal and fingering suggestions to aid in achieving a stylistic performance. Titles: Clap Yo' Hands * Do-Do-Do * Do It Again * Fascinating Rhythm * I Got Rhythm * I'll Build a Stairway to Paradise * Jasbo Brown Blues * Liza (All the Clouds'll Roll Away) * The Man I Love * Merry Andrew * My One and Only * Nobody but You * Oh, Lady Be Good * Prelude I * Prelude II (Blue Lullaby) * Prelude III (Spanish Prelude) * Prelude (Novelette in Fourths) * Prelude (Rubato) * Prelude (Melody No. 17) * Prelude (Fragment) * Promenade * Rhapsody in Blue (for Solo Piano) * Rialto Ripples * Somebody Loves Me * Strike Up the Band * Swanee * Sweet and Low Down * Swiss Miss * 'S Wonderful * That Certain Feeling * Three-Quarter Blues * Two Waltzes in C * Who Cares? (So Long As You Care for Me).

These and 18 other entertaining and instructive stories from Jewish legend and lore are sure to enthrall a new generation of fairy tale enthusiasts. The Sewing Room Sampler combines two of Yoko Saito's favourites: blocks featuring traditional quilting motifs, such as stars and houses, plus one-of-a-kind sewing-themed applique designs. You can use the block and applique designs individually, or combine them to create this quilting masterpiece. This quilt makes the perfect decoration for a sewing room or home of afellow quilter. Step-by-step colour instructions illustrate how to piece the 16 blocks together and assemble the quilt. Full-size templates of the applique motifs are included on pattern sheets. Germany is the most heavily populated of all the countries within the European Union. A Traveller's History of Germany offers a complete and authoritative history of a country of which much of its rich past and legacy of great culture has been forgotten after the traumas of the two world wars. There were Faber New Poets: No. 14 download PDF Germans long before there was Germany. Germanic peoples lived for centuries in Western, Central and Eastern Europe with similar yet not identical languages and culture. Over time these developed into regional principalities and city states under the nominal rule of first the Roman Empire, then the Holy Roman Empire, and finally the Habsburg Empire. German unification did not come until 1871 under Bismarck. Germany became a world power, fuelled not only by industrialization but also by a new ideology of nationalism, a power that took on the rest of the world twice in the twentieth century and lost. Since 1945 it has risen from the ashes to become a major force--of a more palatable kind--within Europe. Cole presents the facts in a clear and literate format and also gives the reader expert analysis of the events.

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Peter Sander: What Would Steve Jobs Do? How the Steve Jobs Way Can Inspire Anyone to Think Differently and Win

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"Part of me admires the entrepreneurial acumen of this experienced commenter on innovation, marketing and economics: this is his 28th book on these subjects. After all, someone was going to write this book, so it might as well be someone who knows what he's talking about. That's what Steve Jobs would have done". ("Engineering & Technology", February 2012). "If you want to understand the Steve Jobs and Apple stories in a couple of hours, then this could be a useful read". ("People Management", February 2012).

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E E Knight: Valentine's Rising

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Returning to the Ozark Territories, freedom fighter David Valentine is shocked to find it overrun by vampiric Kurians under the command of the merciless Consul Solon. In a desperate gambit, Valentine leads a courageous group of soldiers on a mission to drive a spike into the gears of the Kurian Order. Valentine stakes life, honor, and the future of his home in a rebellion that sparks the greatest battle of his life.

This is a book about an ocean that vanished six million years ago - the ocean of Tethys. Named after a Greek sea nymph, there is a sense of mystery about such a vast, ancient ocean, of which all that remains now are a few little pools, like the Caspian Sea. There were other great oceans in the history of the Earth - Iapetus, Panthalassa - but Tethys was the last of them, vanishing a mere moment (in geological terms) before Man came on the scene. Once Tethys stretched across the world. How do we know? And how could such a vast ocean vanish? The clues of its existence are scattered Valentine's Rising free download pdf from Morocco to China. This book tells the story of the ocean, from its origins some 250 million years ago, to its disappearance. It also tells of its impact on life on Earth. The dinosaurs were just beginning to get going when Tethys formed, and they were long dead by the time it disappeared. Dorrik Stow describes the powerful forces that shaped the ocean; the marine life it once held and the rich deposits of oil that life left behind; the impact of its currents on environment and climate. It is rarely realized how very important oceans are to climate and environment, and therefore to life on Earth.

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Josep Malvehy,Ralph P. Braun,Susana Puig,Ashfaq A. Marghoob,Alfred W. Kopf: Handbook of Dermoscopy

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The rise in popularity of dermoscopy has meant that more and more practitioners need a ready reference to consult in a clinical setting where larger atlases are less practical. The Handbook of Dermoscopy features a wealth of photographs, checklists, and algorithms to assist in spot diagnoses. Coverage includes melanocytic lesions, seborrheic keratosis, basal cell carcinoma, dermatofibroma, vascular lesions. Melanoma, pattern analyses, the ABCD/ABC/ABCDE rule, and Menzies's method.

The sensual and provocative second volume in the "Cairo Trilogy", "Palace Of Desire" follows the Al Jawad family into the awakening world of the 1920's and the sometimes violent clash between Islamic ideals, personal dreams and modern realities. Having given up his vices after his son's death, ageing patriarch Al-Sayyid Ahmad pursues an arousing lute-player - only to find she has married his eldest son. His rebellious children struggle to move beyond his domination as they test the loosening reins of societal and parental Handbook of Dermoscopy download PDF control. And Ahmad's youngest son, in an unforgettable portrayal of unrequited love, ardently courts the sophisticated daughter of a rich Europeanised family. Key Features: LEGO(r) "DC Comics Character Encyclopedia" is a comprehensive visual guide to the full range of LEGO DC Comics Super Heroes minifigures, including Batman, Superman, and their friends and foes.Learn little-known facts and figures about all the characters from the LEGO DC Comics Super Heroes universe including Green Lantern, the Joker, and Wonder Woman. Find out details on the various sets and where each minifigure appears, as well as their special weapons, cool gadgets, and amazing vehicles.LEGO "DC Comics Character Encyclopedia" is the must-have guide to the LEGO DC Comics minifigures.LEGO, the LEGO logo, the Brick and Knob configurations and the Minifigure are trademarks and/or copyrights of the LEGO Group. (c)2015 The LEGO Group. All Rights Reserved.Produced by DK Publishing under license from the LEGO Group.Copyright (c) 2015 DC Comics. All related characters and elements are trademarks of and (c) DC Comics. (s15)

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Thornton Waldo Burgess: The Adventures of Poor Mrs. Quack

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One day, Peter Rabbit happens upon a surprise visitor to the Smiling Pool. It's Mrs. Quack the Duck, who is dreadfully upset after having narrowly escaped some hunters and their terrible guns. Worst of all, she has lost Mr. Quack, her husband, and doesn't know whether he is alive or dead. Peter, Jerry Muskrat, and the other animals in the Green Forest vow to help Mrs. Quack find a safe place to live and to try and locate Mr. Quack. Sammy Jay and Blacky the Crow, two of the sharpest-eyed animals in the Green Forest, are enlisted to help and soon the search is under way. As children learn about the misfortunes of Mrs. Quack and the problems faced by migrating ducks, they will develop new respect for wildlife and a deeper understanding of real animals and their struggle to survive. Best of all, the lessons are incorporated into a good story, told with the warmth and charm that have made Thornton W. Burgess stories favorites with children for generations. Completely reset in large, easy-to-read type, the text is enhanced by six full-page illustrations based on Harrison Cady's originals.

SUPERCHARGE your understanding of ELECTRONICS Learn electronics without getting your wires crossed! Electronics Demystified, Second Edition teaches you fundamental concepts and applications step by step. This practical guide begins by covering voltage, current, resistance, impedance, admittance, and power supplies. The book The Adventures of Poor Mrs. Quack download ebook goes on to discuss semiconductor diodes, transistors, integrated circuits, and signal amplifiers and oscillators. Wireless electronics is then addressed, including radio-frequency transmitters and receivers, telecommunications, and antennas. Detailed examples make it easy to understand the material. End-of-chapter quizzes and a final exam help reinforce key topics. It's a no-brainer! You'll learn about: Ohm's law Current and voltage in RL and RC circuits Oscillation and amplification Bipolar and field-effect transistors Radio-wave propagation Receiver and transmitter design Communications satellites and antennas Simple enough for a beginner, but challenging enough for an advanced student, Electronics Demystified, Second Edition helps you master this essential subject.

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Kenneth Grahame,Michel Plessix,Luke Spear: The Wind in the Willows: v. 3: The Great Escape

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Kenneth Grahame's "The Wind in the Willows" is a treasure of British Literature which has already been brought to screen and now has its first ever comic book interpretation. His colourful characters, his inimitable madness and his love of nature shine through on every page and have fascinated countless readers of all ages...amongst whom was Michel Plessix, the author of this tender and lively adaptation.

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