Reviews withdrawn draft guidance on analytical similarity assessment. Evaluates various methods for analytical similarity evaluation based on FDA’s current guidelines. Provides a general approach for the use of n-of-1 trial design for assessment of interchangeability. Discusses the feasibility and validity of the non-medical switch studies. Provides innovative thinking for detection of possible reference product change over time.

Methodologies for Biosimilar Product Development covers the practical and challenging issues that are commonly encountered during the development, review, and approval of a proposed biosimilar product. These practical and challenging issues include, but are not limited to the mix-up use of interval hypotheses testing (i.e., the use of TOST) and confidence interval approach, a risk/benefit assessment for non-inferiority/similarity margin, PK/PD bridging studies with multiple references, the detection of possible reference product change over time, design and analysis of biosimilar switching studies, the assessment of sensitivity index for assessment of extrapolation across indications without collecting data from those indications not under study, and the feasibility and validation of non-medical switch post-approval. Key Features: Reviews withdrawn draft guidance on analytical similarity assessment. Evaluates various methods for analytical similarity evaluation based on FDA's current guidelines. Provides a general approach for the use of n-of-1 trial design for assessment of interchangeability. Discusses the feasibility and validity of the non-medical switch studies. Provides innovative thinking for detection of possible reference product change over time. This book embraces innovative thinking of design and analysis for biosimilar studies, which are required for review and approval of biosimilar regulatory submissions.

South Korean cinema is a striking example of non-Western contemporary cinematic success. Thanks to the increasing numbers of moviegoers and domestic films produced, South Korea has become one of the world's major film markets. In 2001, the South Korean film industry became the first in recent history to reclaim its domestic market from Hollywood and continues to maintain around a 50 percent market share today. High-quality South Korean films are increasingly entering global film markets and connecting with international audiences in commercial cinemas and art theatres, and at major international film festivals. Despite this growing recognition of the films themselves, Korean cinema's rich heritage has not heretofore received significant scholarly attention in English-language publications. This groundbreaking collection of thirty-five essays by a wide range of academic specialists situates current scholarship on Korean cinema within the ongoing theoretical debates in contemporary global film studies. Chapters explore key films of Korean cinema, from Sweet Dream, Madame Freedom, The Housemaid, and The March of Fools to Oldboy, The Host, and Train to Busan, as well as major directors such as Shin Sang-ok, Kim Ki-young, Im Kwon-taek, Bong Joon-ho, Hong Sang-soo, Park Chan-wook, and Lee Chang-dong. While the chapters provide in-depth analyses of particular films, together they cohere into a detailed and multidimensional presentation of Korean cinema's cumulative history and broader significance. With its historical and critical scope, abundance of new research, and detailed discussion of important individual films, Rediscovering Korean Cinema is at once an accessible classroom text and a deeply informative compendium for scholars of Korean and East Asian studies, cinema and media studies, and communications. It will also be an essential resource for film industry professionals and anyone interested in international cinema.

South Korean cinema is a striking example of non-Western contemporary cinematic success. Thanks to the increasing numbers of moviegoers and domestic films produced, South Korea has become one of the world's major film markets. In 2001, the South Korean film industry became the first in recent history to reclaim its domestic market from Hollywood and continues to maintain around a 50 percent market share today. High-quality South Korean films are increasingly entering global film markets and connecting with international audiences in commercial cinemas and art theatres, and at major international film festivals. Despite this growing recognition of the films themselves, Korean cinema's rich heritage has not heretofore received significant scholarly attention in English-language publications. This groundbreaking collection of thirty-five essays by a wide range of academic specialists situates current scholarship on Korean cinema within the ongoing theoretical debates in contemporary global film studies. Chapters explore key films of Korean cinema, from Sweet Dream, Madame Freedom, The Housemaid, and The March of Fools to Oldboy, The Host, and Train to Busan, as well as major directors such as Shin Sang-ok, Kim Ki-young, Im Kwon-taek, Bong Joon-ho, Hong Sang-soo, Park Chan-wook, and Lee Chang-dong. While the chapters provide in-depth analyses of particular films, together they cohere into a detailed and multidimensional presentation of Korean cinema's cumulative history and broader significance. With its historical and critical scope, abundance of new research, and detailed discussion of important individual films, Rediscovering Korean Cinema is at once an accessible classroom text and a deeply informative compendium for scholars of Korean and East Asian studies, cinema and media studies, and communications. It will also be an essential resource for film industry professionals and anyone interested in international cinema.

Cinema and the Cultural Cold War explores the ways in which postwar Asian cinema was shaped by transnational collaborations and competitions between newly independent and colonial states at the height of Cold War politics. Sangjoon Lee adopts a simultaneously global and regional approach when analyzing the region's film cultures and industries. New economic conditions in the Asian region and shared postwar experiences among the early cinema entrepreneurs were influenced by Cold War politics, US cultural diplomacy, and intensified cultural flows during the 1950s and 1960s. By taking a closer look at the cultural realities of this tumultuous period, Lee comprehensively reconstructs Asian film history in light of the international relationships forged, broken, and re-established as the influence of the non-aligned movement grew across the Cold War. Lee elucidates how motion picture executives, creative personnel, policy makers, and intellectuals in East and Southeast Asia aspired to industrialize their Hollywood-inspired system in order to expand the market and raise the competitiveness of their cultural products. They did this by forming the Federation of Motion Picture Producers in Asia, co-hosting the Asian Film Festival, and co-producing films. Cinema and the Cultural Cold War demonstrates that the emergence of the first intensive postwar film producers' network in Asia was, in large part, the offspring of Cold War cultural politics and the product of American hegemony. Film festivals that took place in cities as diverse as Tokyo, Singapore, Hong Kong, and Kuala Lumpur were annual showcases of cinematic talent as well as opportunities for the Central Intelligence Agency to establish and maintain cultural, political, and institutional linkages between the United States and Asia during the Cold War. Cinema and the Cultural Cold War reanimates this almost-forgotten history of cinema and the film industry in Asia.

Collectively known as Hallyu, Korean music, television programs, films, online games, and comics enjoy global popularity, thanks to new communication technologies. In recent years, Korean popular culture has also become the subject of academic inquiry. Whereas the Hallyu's impact on Korea's national image and domestic economy, as well as on transnational cultural flows, have received much scholarly attention, there has been little discussion of the role of social media in Hallyu's propagation. Contributors to Hallyu 2.0: The Korean Wave in the Age of Social Media explore the ways in which Korean popular cultural products are shared by audiences around the globe; how they generate new fans, markets, and consumers through social media networks; and how scholars can analyze, interpret, and envision the future of this unprecedented cultural phenomenon.

Cinema and the Cultural Cold War explores the ways in which postwar Asian cinema was shaped by transnational collaborations and competitions between newly independent and colonial states at the height of Cold War politics. Sangjoon Lee adopts a simultaneously global and regional approach when analyzing the region's film cultures and industries. New economic conditions in the Asian region and shared postwar experiences among the early cinema entrepreneurs were influenced by Cold War politics, US cultural diplomacy, and intensified cultural flows during the 1950s and 1960s. By taking a closer look at the cultural realities of this tumultuous period, Lee comprehensively reconstructs Asian film history in light of the international relationships forged, broken, and re-established as the influence of the non-aligned movement grew across the Cold War. Lee elucidates how motion picture executives, creative personnel, policy makers, and intellectuals in East and Southeast Asia aspired to industrialize their Hollywood-inspired system in order to expand the market and raise the competitiveness of their cultural products. They did this by forming the Federation of Motion Picture Producers in Asia, co-hosting the Asian Film Festival, and co-producing films. Cinema and the Cultural Cold War demonstrates that the emergence of the first intensive postwar film producers' network in Asia was, in large part, the offspring of Cold War cultural politics and the product of American hegemony. Film festivals that took place in cities as diverse as Tokyo, Singapore, Hong Kong, and Kuala Lumpur were annual showcases of cinematic talent as well as opportunities for the Central Intelligence Agency to establish and maintain cultural, political, and institutional linkages between the United States and Asia during the Cold War. Cinema and the Cultural Cold War reanimates this almost-forgotten history of cinema and the film industry in Asia.

Collectively known as Hallyu, Korean music, television programs, films, online games, and comics enjoy global popularity, thanks to new communication technologies. In recent years, Korean popular culture has also become the subject of academic inquiry. Whereas the Hallyu's impact on Korea's national image and domestic economy, as well as on transnational cultural flows, have received much scholarly attention, there has been little discussion of the role of social media in Hallyu's propagation. Contributors to Hallyu 2.0: The Korean Wave in the Age of Social Media explore the ways in which Korean popular cultural products are shared by audiences around the globe; how they generate new fans, markets, and consumers through social media networks; and how scholars can analyze, interpret, and envision the future of this unprecedented cultural phenomenon.