TY  - GEN
T1  - Pediatric non-clinical drug testing principles, requirements, and practice
A2  - Hoberman, Alan M.
A2  - Lewis, Elise M.
LA  - English
PP  - Hoboken, N.J.
PB  - John Wiley & Sons
YR  - 2012
UL  - https://colectivo.uloyola.es/Record/ELB179200
AB  - "This book explains the importance and practice of pediatric drug testing for pharmaceutical and toxicology professionals. It describes the practical and ethical issues regarding non-clinical testing to meet US FDA Guidelines, differences resulting from the new European EMEA legislation, and how to develop appropriate information for submission to both agencies. It also provides practical study designs and approaches that can be used to meet international requirements. Covering the full scope of non-clinical testing, regulations, models, practice, and relation to clinical trials, this text offers a comprehensive and up-to-date resource"--Provided by publisher.
OP  - 339
CN  - RM301.25 .P43 2012
SN  - 9781118168264 (electronic bk.)
KW  - Drug development : United States.
KW  - Pediatric pharmacology : United States.
KW  - Pediatrics : United States : Formulae, receipts, prescriptions : Safety measures.
KW  - Electronic books.
ER  -