Pharmaceutical medicine and translational clinical research / edited by Divya Vohora, Gursharan Singh.

Contents 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.
Bibliography noteIncludes bibliographical references and index.
Access restrictionAvailable only to authorized users.
Technical detailsMode of access: World Wide Web
Genre/formElectronic books.
LCCN 2017278984
ISBN9780128021033 (paperback)
ISBN0128021039 (paperback)

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