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CGMP
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91	CGMP for PET Drugs - 21 CFR 212 Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Title 21 of the Code of Federal Regulations Good manufacturing practice Center for Drug Evaluation and Research Positron emission tomography Investigational New Drug Validation Drug Master File Medicine Health Food and Drug Administration
92	FDA’s Response to Issues Raised by the PET Community Regarding the 1999 Preliminary Draft Regulations on CGMP for PET Drugs In its comments on the preliminary draft regulations on CGMP for PET drug products that FDA is Add to Reading List Source URL: www.fda.gov Language: English Validity Research Pharmacology Clinical research Quality Validation Food and Drug Administration Pharmaceutical sciences Pharmaceutical industry Food and drink
93	INVESTIGATIONS OPERATIONS MANUAL[removed]EXHIBIT 5-14 PROFILING A FIRM’S CGMP/QS COMPLIANCE STATUS Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Pharmaceuticals policy Sterilization Health Quality management system Medicine Quality management Food safety Good manufacturing practice
94	V Contents Preface XV Introduction XVII Abbreviations XXI Add to Reading List Source URL: www.wiley-vch.de Language: English - Date: 2010-06-24 21:03:59 Lactams CGMP-specific phosphodiesterase type 5 Rifamycin Camptothecin Protease inhibitor Zaprinast Organic chemistry Pharmacology PDE5 inhibitors Chemistry ACE inhibitors
95	PDF Document Add to Reading List Source URL: www.wiley-vch.de Language: English - Date: 2014-03-03 21:03:11 Lactams Biology PDE5 inhibitors Pyridines Pfizer CGMP-specific phosphodiesterase type 5 Phosphodiesterase Tadalafil PDE3 Chemistry Organic chemistry Molecular biology
96	PDF Document Add to Reading List Source URL: www.wiley-vch.de Language: English - Date: 2014-03-03 21:03:11 Enzymes Phosphodiesterase inhibitor Pyridines CGMP-specific phosphodiesterase type 5 Phosphodiesterase 2 Phosphodiesterase PDE3 inhibitor Cyclic nucleotide phosphodiesterase PDE5 inhibitor Chemistry Molecular biology Organic chemistry
97	PDF Document Add to Reading List Source URL: www.wiley-vch.de Language: English - Date: 2014-03-03 21:03:11 Molecular biology Enzymes CGMP-specific phosphodiesterase type 5 Phosphodiesterase inhibitors Phosphodiesterase-4 inhibitor PDE5 inhibitor Phosphodiesterase Cilomilast PF-2545920 Chemistry Organic chemistry Pyridines
98	HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use STAXYN safely and effectively. See full prescribing information for STAXYN. STAXYN (vardenafil hydrochloride) orally Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2014-04-30 17:40:13 Lactams Piperazines GlaxoSmithKline Sulfones Vardenafil CGMP-specific phosphodiesterase type 5 Erectile dysfunction Tadalafil Sildenafil Organic chemistry Chemistry PDE5 inhibitors
99	HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LEVITRA safely and effectively. See full prescribing information for LEVITRA. LEVITRA (vardenafil hydrochloride) tab Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2014-04-30 17:40:11 PDE5 inhibitors Piperazines GlaxoSmithKline Sulfones Vardenafil CGMP-specific phosphodiesterase type 5 Erectile dysfunction Oxazepam Tadalafil Organic chemistry Chemistry Lactams
100	HIGHLIGHTS OF PRESCRIBING INFORMATION • These highlights do not include all the information needed to use ADCIRCA safely and effectively. See full prescribing information Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2014-04-30 17:40:12 Eli Lilly and Company PDE5 inhibitors Tadalafil Organochlorides Amines CGMP-specific phosphodiesterase type 5 Pulmonary hypertension Phosphodiesterase inhibitor Methadone Lactams Chemistry Organic chemistry

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