LEADER 03098nam 2200397 450 001 9910297396503321 005 20230120002734.0 010 $a0-12-802098-9 010 $a0-12-802103-9 035 $a(CKB)4100000000864063 035 $a(MiAaPQ)EBC5122255 035 $a(EXLCZ)994100000000864063 100 $a20171204h20182018 uy 0 101 0 $aeng 135 $aurcnu|||||||| 181 $2rdacontent 182 $2rdamedia 183 $2rdacarrier 200 00$aPharmaceutical medicine and translational clinical research /$fedited by Divya Vohora, Gursharan Singh 210 1$aLondon, England :$cAcademic Press,$d2018. 210 4$dİ2018 215 $a1 online resource (498 pages) $cillustrations 320 $aIncludes bibliographical references and index. 327 $aThe 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. 606 $aClinical medicine$xResearch 615 0$aClinical medicine$xResearch. 676 $a616.0072 702 $aVohora$b Divya 702 $aSingh$b Gursharan 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910297396503321 996 $aPharmaceutical medicine and translational clinical research$92158047 997 $aUNINA