Innovation in the Pharmaceutical Industry: The Process of Drug Discovery and Development

nnovation in the Pharmaceutical Industry: The Process of Drug Discovery and Development
By Takuji Hara

Publisher: Edward Elgar Publishing
Number Of Pages: 288
Publication Date: 2003-04
ISBN-10 / ASIN: 1843760509
ISBN-13 / EAN: 9781843760504

Product Description:

Innovation in the Pharmaceutical Industry traces the discovery and development of drugs in Japan and the UK both historically and sociologically. It includes sixteen case studies of major pharmaceutical developments in the twentieth century, encompassing, among others, beta-blockers, beta-stimulants, inhaled steroids and histamine H2-antagonists.

The book illustrates that the four stages of drug development – namely compound, application, organizational authorization and market – are interactively shaped by heterogeneous actors and institutions. The book also identifies three different types of pharmaceutical development – paradigmatic innovation, application innovation and modification-based innovation, all with distinguishable features in the drug development process. Finally, several historical, structural and cultural factors influencing the shaping of medicines are revealed by the comparison between British and Japanese drug innovation.

Addressing a number of practical implications for the promotion of the pharmaceutical industry, this book will be of enormous interest to students, researchers and academics specializing in science and technology, and the management of technology and innovation. Practitioners, managers, and policy planners within the pharmaceutical industry will also deem this book invaluable.

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Handbook Of Pharmaceutical Manufacturing Formulation Liquid

The third volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers liquid drugs, which include formulations of non-sterile drugs administered by any route in the form of solutions (monomeric and multimeric), suspensions (powder and liquid), drops, extracts, elixirs, tinctures, paints, sprays, colloidons, emulsions, aerosols, and other fluid preparations from publicly available but widely dispersed information from FDA New Drug Applications (NDA), patent applications, and other sources of generic and proprietary formulations. Each entry begins with a fully validated scaleable manufacturing formula and a summary of manufacturing process. The book provides a detailed discussion on the difficulties encountered in formulating and manufacturing liquid drugs, the common elements of formulation. The section on regulatory and manufacturing guidance deals with the topics of changes to approved NDAs and aNDAs, post-approval changes to semisolid drugs, global manufacturing practices and guidelines, compliance program guidance manual for FDA staff covering drug manufacturing inspections program, waiver of in vivo bioavailability studies for immediate release solid drugs based on a biopharmaceutics classification, in addition to providing quick tips on resolving the common problems in formulating uncompressed drugs.

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