http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
Pharmaceutical medicine and translational clinical research
Pharmaceutical Medicine and Translational Clinical Research covers clinical testing of medicines and the translation of pharmaceutical drug research into new medicines, also focusing on the need to understand the safety profile of medicine and the benefit-risk balance. Pharmacoeconomics and the social impact of healthcare on patients and public health are also featured. It is written in a clear and straightforward manner to enable rapid review and assimilation of complex information and contains reader-friendly features. As a greater understanding of these aspects is critical for students in the areas of pharmaceutical medicine, clinical research, pharmacology and pharmacy, as well as professionals working in the pharmaceutical industry, this book is an ideal resource.
The speciality of pharmaceutical medicine / Gerfried K.H. Nell -- Drug discovery and development / Sandeep Sinha and Divya Vohora -- Pharmaceutical development / Harinder Singh, Lalit K. Khurana, and Romi Singh -- Preclinical drug development / Gusharan Singh -- Target product profile / Gusharan Singh -- Clinical pharmacokinetics and drug interaction / Nilanjan Saha -- Pharmacogenomics / Ankit Srivastava, Debleena Guin, Ritushree Kukreti, and Divya Vohora -- Clinical research quality assurance and audits / Geeta O. Bedi -- Pharmaceutical medicine and law / Gusharan Singh -- Pharmaceutical regulations in the United States / Sunita Narang -- Pharmaceutical regulations in European Union / Bharti Khanna -- Pharmaceutical regulations in India / Nidhi B. Agarwal and Manoj Karwa -- Pharmaceutical regulations for complementary medicine / Preeti Vyas and Divya Vohora -- Ethical considerations in clinical research / Divya Vohora -- Patent / Bindu Sharma -- Copyright / Bindu Sharma -- Trademark / Bindu Sharma -- Trade secret / Bindo Sharma -- Data exclusivity / Gursharan Singh -- Generic drug and bioequivalence studies / Rajinder K. Jalali and Deepa Rasaily -- Vaccines / Subodh Bhardwaj -- Biosimilars / Gursharan Singh -- Re-innovation in pharmaceutical industry / Gusharan Singh -- Phase IV studies and lifecycle management / Gerfried K.H. Nell -- Medical affairs / Gerfried K.H. Nell -- Pharmacovigilance and drug safety / Rajinder K. Jalali -- Clinical and post approval safety data management / Rajinder K. Jalali -- Individual case safety reports / Rajinder K. Jalali -- Development and periodic safety reports / Rajinder K. Jalali -- Risk management in pharmacovigilance / Rajinder K. Jalali -- Recent developments in pharmacovigilance at UMC / Sten Olsson -- Tools for assessing and monitoring medicine use / Sangeeta Sharma -- Pharmacoeconomics in healthcare / Mahendra Rai and Richa Goyal.
edited by Divya Vohora, Gursharan Singh.
Includes bibliographical references and index.
London : Academic Press, an imprint of Elsevier, [2018]