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numbers in italics indicate Figures and Tables; suffix 'n' denotes a footnote Abbreviated New Drug Applications (ANDAs) 382, 399, 412-14 component parts 413 supporting information 412-13 abstracts, isolated, publishing of clinical trials in 568-9 Academy of Managed Care Pharmacy (AMCP) formulary dossier 741 accelerated approvals for ANDAs and generics 412-14 post-marketing impacts/studies 411, 413 for serious and life-threatening diseases 410-12 accounting, clinical trial costs 694 acetaminophen/paracetamol 376-7 acetylation (metabolic) pathways, ethnic differences 234, 541 N-acetylcysteine 377 actual-use ('slice-of-life') studies 187, 188 additivity of drugs 256 adherence 355 see also compliance Administration of Radioactive Substances Advisory Committee (ARSAC) 452 adverse drug reaction (ADR) reporting system Europe 133, 429-30, 477-80 Japan 504-5 adverse events (AEs) in complementary therapies 391-2 definition 133, 477, 539 EBGM scores 546-7 in elderly people 194-5 European database 445, 477 first known investigation 423 gender differences 213 handling/dealing with 35-6, 581-2 ICH GCP guidelines for reporting 133, 538-9 reportability assessment flowchart 478-9 reporting and recording 133, 148, 150, 151, 477-80, 535-43 in China 673 electronic reports 132-3 ethnic differences 239-40 in UK 425, 429 in USA 133, 524-5, 548 type A and type B 536 types 610 advertising clinical trial subjects 134, 200, 694 pharmaceutical Medical Affairs Department's responsibilities 525 in medical journals 657, 658 regulation of 481-2, 525, 531, 656 US spend 657 aerosols 56 agencies Malaysia 684 Middle East 678 aging population impact on society 194 see also elderly population; geriatrics agonist-antagonists, pharmacodynamics 90 agonists, full 90 alcohol effects, ethnic differences 237 alkaloids 388 allometric scaling 83, 86 in drug discovery process 86-9, 95 alternative liability 613 alternative medicine see complementary medicine(s) Alzheimer's disease 48, 194, 198 American Academy of Pharmaceutical Physicians (AAPP), career satisfaction survey 5 analgesic, concentration-time effect modelling 92 analysis-of-variance (ANOVA) model 326 analytical methods, for dose and plasma determinations 65-6 animal experimentation, ethics 591-2 animal models 48, 49, 66, 499 antagonism between drugs 256 Anti-Kickback Statute 596 antibodies, as biotechnology products 284 antidotes, early developments 415-17 antiepileptic drugs 206, 207-8, 376 antisense oligonucleotides 47, 285-6 Apothecaries 395, 417-18 inspection of shops 419-21 appraisals, training 17-18 archiving of documents 133, 141, 152, 168 audits 174-5 Argentina, postgraduate education 23 Armitage ('sequential analysis') clinical trial design 110 arthritis 198 ascending dose-ranging cohort design 108-9 Asia, pharmaceutical medicine in 680-7 aspirin 105