Related by context. Frequent words. (Click for all words.) 65 CGMP 62 Product Characteristics 62 QbD 62 preclinical efficacy 59 Bioequivalence 59 efficacy tolerability 58 Hexvix 58 Bioavailability 58 bioequivalence 58 GxP 58 Recommended Practices 57 Biosimilar 57 Recombinant Human 57 PK PD 57 BrachySil 57 Accelerated Approval 57 FDAAA 57 Manufacturing Practices GMP 57 eprotirome 57 pharmacokinetic studies 57 Plenaxis R 57 bioequivalence studies 56 FFDCA 56 Laboratory Practice GLP 56 preclinical toxicology 56 FIRAZYR 56 Onko Sure ® 56 alvimopan 56 peptide synthesis 56 faropenem 56 Factor VIIa 56 Manufacturing Practice cGMP 56 PGx 56 Icatibant 56 Mitigation Strategy REMS 56 Confirmatory 56 IND submission 55 Phase III Clinical Trial 55 APTIVUS 55 pharmacokinetic profiles 55 Pharmacovigilance 55 Manufacturing Practice GMP 55 lanthanum carbonate 55 Omacor 55 Manufacturing Practices cGMP 55 THALOMID 55 radiolabeled 55 molecular biomarkers 55 Pennsaid R 55 ATL# [001] 55 CHMP recommendation 55 liprotamase 55 MHLW 55 TYGACIL 54 LC MS MS 54 Tekturna HCT 54 AdreView 54 SEPET TM 54 Neuradiab 54 DermaVir 54 MAA submission 54 rHuPH# 54 pharmacovigilance 54 AZILECT R 54 PREOS 54 Pharmacopoeia 54 Sitagliptin 54 Molecular Diagnostic 54 Trofex 54 GLP compliant 54 CE Marked 54 mesylate 54 Lubiprostone 54 VKORC1 54 genotoxicity 53 PRIALT 53 ATryn ® 53 Panzem R 53 Multiferon R 53 liposomal formulation 53 Ciclesonide 53 Genz # 53 insulin analogs 53 Microbiological 53 SILENOR ™ 53 biomarker assays 53 allergenicity 53 Captisol 53 Technical Specifications 53 optical biosensors 53 human antithrombin 53 bioanalysis 53 MoxDuo IR 53 Vitro Diagnostic 53 pancreatic enzyme 53 pharmacoeconomic 53 FDA Accepts 53 CTA# 53 Elafin 53 Plicera 53 BLA submission