"When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. …
Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality syst…
"This book examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, q…
Presenting research from the UK, USA, Sweden, and the Netherlands, the ethnographic perspective adopted by the authors provides a space to explore the investments of different state, market, professional and other actors in particular forms of evaluation.
Clinical trials have become key technologies for decision making in the contemporary world. Their results shape medical practice and determine priorities across health care systems, but the work that goes into producing credible data is often hidden. Medical Proofs, Social Exper…
1. Clinical trials go global -- 2. The placebo control -- 3. Growing the pharma monolith -- 4. Uncaging the guinea pig -- 5. HIV and the second-rate solution -- 6. South Africa : drug trials and AIDS denialism -- 7. Outsourcing to India : the one billion body politic -- 8. Calib…
"The Body Hunters recounts the way the multinational pharmaceutical industry, in its quest to develop lucrative drugs, has begun quietly exporting its clinical research business to the developing world, where ethical oversight is minimal and desperate patients abound. Faced with…
Hailed by John le Carré as "an act of courage on the part of its author" and singled out for praise by the leading medical journals in the United States and the United Kingdom, The Body Hunters uncovers the real-life story behind le Carré's acclaimed novel The Constant Gardener …