HRP20200060T1 - Nova uporaba - Google Patents

Nova uporaba Download PDF

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Publication number
HRP20200060T1
HRP20200060T1 HRP20200060TT HRP20200060T HRP20200060T1 HR P20200060 T1 HRP20200060 T1 HR P20200060T1 HR P20200060T T HRP20200060T T HR P20200060TT HR P20200060 T HRP20200060 T HR P20200060T HR P20200060 T1 HRP20200060 T1 HR P20200060T1
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HR
Croatia
Prior art keywords
medicine
use according
reducing
dose
heart failure
Prior art date
Application number
HRP20200060TT
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English (en)
Inventor
Victor Chengwei Shi
Martin Lefkowitz
Adel Remond RIZKALA
Original Assignee
Novartis Ag
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=51494327&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20200060(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from PCT/US2013/056680 external-priority patent/WO2015030711A1/en
Application filed by Novartis Ag filed Critical Novartis Ag
Publication of HRP20200060T1 publication Critical patent/HRP20200060T1/hr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/21Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/216Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/21Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A61K31/225Polycarboxylic acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/401Proline; Derivatives thereof, e.g. captopril
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/12Antihypertensives

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  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Emergency Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Transition And Organic Metals Composition Catalysts For Addition Polymerization (AREA)

Claims (23)

1. Lijek, naznačen time, što sadrži a) terapeutski učinkovitu količinu spoja trinatrijevog [3-((1S,3R)-1-bifenil-4-ilmetil-3-etoksikarbonil-1-butilkarbamoil)propionat-(S)-3'-metil-2'-(pentanoil{2"-(tetrazol-5-ilat)bifenil-4'-ilmetil}amino)butirat] hemipentahidrata (LCZ696) ili b) kombinaciju koja sadrži terapeutski učinkovitu količinu u molarnom omjeru 1:1 pojedinačnih spojeva (i) valsartana ili njegove farmaceutski prihvatljive soli; i (ii) sakubitrila ili njegove farmaceutski prihvatljive soli, za uporabu u smanjivanju stope rizika od kardiovaskularne smrti i/ili hospitalizacija zbog zatajenja srca kod ljudskog pacijenta koji pati od kroničnog zatajenja srca klasificiranog kao razred NYHA II, III ili IV te sistoličke disfunkcije.
2. Lijek za uporabu prema patentnom zahtjevu 1, naznačen time, što se pokazalo da je lijek statistički superiorniji u smanjenju stope kardiovaskularne smrti i/ili hospitalizacija zbog zatajenja srca, izraženo kao najmanje 20% stopa smanjenja rizika u odnosu na ACE inhibitor enalapril koji se primjenjuju dva puta dnevno u dozi od 10 mg svaki puta.
3. Lijek za uporabu prema patentnom zahtjevu 2, naznačen time, što se pokazalo da je lijek statistički superiorniji u smanjenju stope kardiovaskularne smrti, izraženo kao najmanje 20% stopa smanjenja rizika u odnosu na ACE inhibitor enalapril koji se primjenjuju dva puta dnevno u dozi od 10 mg svaki puta.
4. Lijek za uporabu prema patentnom zahtjevu 2, naznačen time, što se pokazalo da je lijek statistički superiorniji u smanjenju stope hospitalizacija zbog zatajenja srca, izraženo kao najmanje 20% stopa smanjenja rizika u odnosu na ACE inhibitor enalapril koji se primjenjuju dva puta dnevno u dozi od 10 mg svaki puta.
5. Lijek za uporabu prema patentnom zahtjevu 4, naznačen time, što se pokazalo da je lijek statistički superiorniji u smanjenju stope prve hospitalizacije zbog pogoršanja zatajenja srca, izraženo kao najmanje 20% stopa smanjenja rizika u odnosu na ACE inhibitor enalapril koji se primjenjuju dva puta dnevno u dozi od 10 mg svaki puta.
6. Lijek za uporabu prema patentnom zahtjevu 1, naznačen time, što je za uporabu u smanjivanju stope rizika od kardiovaskularne smrti.
7. Lijek za uporabu prema patentnom zahtjevu 1, naznačen time, što je za uporabu u smanjivanju stope rizika od hospitalizacija zbog zatajenja srca.
8. Lijek za uporabu prema patentnom zahtjevu 7, naznačen time, što je za uporabu u smanjivanju stope rizika od prve hospitalizacije zbog pogoršanja zatajenja srca.
9. Lijek za uporabu prema patentnom zahtjevu 1, naznačen time, što je za uporabu u smanjivanju stope rizika od kardiovaskularne smrti i hospitalizacija zbog zatajenja srca.
10. Lijek za uporabu prema patentnom zahtjevu 1, naznačen time, što je lijek za smanjivanje rizika od kardiovaskularne smrti i/ili hospitalizacija zbog zatajenja srca za iznos od najmanje 20% u odnosu na ACE inhibitor enalapril koji se primjenjuju dva puta dnevno u dozi od 10 mg svaki puta, kod ljudskog pacijenta koji pati od kroničnog zatajenja srca klasificiranog kao razred NYHA II, III ili IV te sistoličke disfunkcije.
11. Lijek za uporabu prema patentnom zahtjevu 10, naznačen time, što je lijek za smanjivanje rizika od kardiovaskularne smrti za iznos od najmanje 20% u odnosu na ACE inhibitor enalapril koji se primjenjuju dva puta dnevno u dozi od 10 mg svaki puta.
12. Lijek za uporabu prema patentnom zahtjevu 10, naznačen time, što je lijek za smanjivanje rizika od hospitalizacija zbog zatajenja srca za iznos od najmanje 20% u odnosu na ACE inhibitor enalapril koji se primjenjuju dva puta dnevno u dozi od 10 mg svaki puta.
13. Lijek za uporabu prema patentnom zahtjevu 12, naznačen time, što je lijek za smanjivanje rizika od prve hospitalizacije zbog pogoršanja zatajenja srca za najmanje 20% u odnosu na ACE inhibitor enalapril koji se primjenjuju dva puta dnevno u dozi od 10 mg svaki puta.
14. Lijek za uporabu prema bilo kojem od prethodnih patentnih zahtjeva 1 do 13, naznačen time, što pacijent ima najmanje jednu od sljedećih dodatnih karakteristika i) povišenu razinu BNP u plazmi ili NT-proBNP, poželjno razinu BNP ≥100 pg/mL u plazmi (ili NT-proBNP ≥400 pg/mL), poželjnije razinu BNP ≥150 pg/mL u plazmi ili NT-proBNP ≥600 pg/mL, i ii) smanjenu frakciju ejekcije lijeve klijetke (LVEF) od ≤40%.
15. Lijek za uporabu prema bilo kojem od prethodnih patentnih zahtjeva 1 do 14, naznačen time, što pacijent ima smanjenu frakciju ejekcije lijeve klijetke (LVEF) od ≤35%.
16. Lijek za uporabu prema bilo kojem od prethodnih patentnih zahtjeva 1 do 15, naznačen time, što pacijent prima osnovni tretman sa stabilnom dozom beta blokatora, antagonistima aldosterona i/ili diuretikom.
17. Lijek za uporabu prema patentnom zahtjevu 16, naznačen time, što pacijent prima osnovni tretman sa stabilnom dozom beta blokatora i po izboru antagonistom aldosterona.
18. Lijek za uporabu prema bilo kojem od prethodnih patentnih zahtjeva 1 do 17, naznačen time, što pacijent, prije primanja lijeka, mora biti na stabilnoj dozi blokatora receptora angiotenzina (ARB) ili ACE inhibitora.
19. Lijek za uporabu prema patentnom zahtjevu 18, naznačen time, što pacijent mora prestati uzimati blokator receptora angiotenzina (ARB) ili ACE inhibitor najmanje 24 sata, poželjno 36 sati, prije uzimanja lijeka.
20. Lijek za uporabu prema bilo kojem od prethodnih patentnih zahtjeva 1 do 19, naznačen time, što time što lijek sadrži LCZ696 i treba se davati oralno u dnevnoj dozi koja može doseći 400 mg uzimanjem u jednom ili više odvojenih unosa.
21. Lijek za uporabu prema patentnom zahtjevu 20, naznačen time, što se lijek treba davati oralno u dnevnoj dozi koja može doseći 400 mg uzimanjem u dva odvojena unosa (b.i.d.).
22. Lijek za uporabu prema patentnom zahtjevu 20 ili 21, naznačen time, što lijek sadrži LCZ696 i treba se davati oralno u početnoj dozi od 100 mg b.i.d. u trajanju od jednog do dva tjedna te nakon toga titriranjem do 200 mg b.i.d.
23. Lijek za uporabu prema bilo kojem od prethodnih patentnih zahtjeva 1 do 19, naznačen time, što lijek obuhvaća kombinaciju koja sadrži terapeutski učinkovitu količinu u molarnom omjeru 1:1 pojedinačnih spojeva (i) Yvalsartana ili njegove farmaceutski prihvatljive soli; i (ii) Ysakubitrila ili njegove farmaceutski prihvatljive soli, i pritom se kombinacija treba davati oralno u dva odvojena unosa (b.i.d.) dnevno, gdje svako uzimanje sadrži 103 mg valsartana, ili njegove farmaceutski prihvatljive soli, te 97 mg sakubitrila, ili njegove farmaceutski prihvatljive soli, po jedinici doziranja.
HRP20200060TT 2013-08-26 2020-01-16 Nova uporaba HRP20200060T1 (hr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
PCT/US2013/056680 WO2015030711A1 (en) 2013-08-26 2013-08-26 New use
US201461972933P 2014-03-31 2014-03-31
EP14761702.1A EP3038654B1 (en) 2013-08-26 2014-08-26 New use
PCT/IB2014/064074 WO2015028941A1 (en) 2013-08-26 2014-08-26 New use

Publications (1)

Publication Number Publication Date
HRP20200060T1 true HRP20200060T1 (hr) 2020-04-03

Family

ID=51494327

Family Applications (2)

Application Number Title Priority Date Filing Date
HRP20240034TT HRP20240034T1 (hr) 2013-08-26 2014-08-26 Liječenje kardiovaskularnih bolesti
HRP20200060TT HRP20200060T1 (hr) 2013-08-26 2020-01-16 Nova uporaba

Family Applications Before (1)

Application Number Title Priority Date Filing Date
HRP20240034TT HRP20240034T1 (hr) 2013-08-26 2014-08-26 Liječenje kardiovaskularnih bolesti

Country Status (15)

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US (2) US20160213646A1 (hr)
EP (3) EP3626270B1 (hr)
JP (1) JP6097888B2 (hr)
CY (1) CY1122531T1 (hr)
DK (2) DK3626270T3 (hr)
ES (2) ES2968541T3 (hr)
FI (1) FI3626270T3 (hr)
HR (2) HRP20240034T1 (hr)
HU (2) HUE064634T2 (hr)
LT (2) LT3038654T (hr)
PL (2) PL3038654T3 (hr)
PT (2) PT3038654T (hr)
RS (2) RS59816B1 (hr)
SI (2) SI3626270T1 (hr)
WO (1) WO2015028941A1 (hr)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016125123A1 (en) * 2015-02-06 2016-08-11 Mylan Laboratories Limited Amorphous trisodium sacubitril valsartan and a process for the preparation thereof
US20180140579A1 (en) * 2015-05-29 2018-05-24 Novartis Ag Sacubitril and valsartan for treating metabolic disease
CN106309388A (zh) * 2015-06-30 2017-01-11 深圳信立泰药业股份有限公司 一种用于心衰治疗的药物组合物及其制备方法
WO2017036420A1 (zh) * 2015-09-06 2017-03-09 常州方楠医药技术有限公司 含沙库比曲和缬沙坦的药用组合物及其制备方法
CN107510653A (zh) * 2016-06-17 2017-12-26 常州爱诺新睿医药技术有限公司 一种含有无定型沙库比曲和缬沙坦的固体分散体的药用组合物及其制备方法
CN106491600A (zh) * 2015-09-06 2017-03-15 常州方楠医药技术有限公司 无定型沙库区比、缬沙坦或其药学上可接受的盐与药用辅料的组合物及其制备方法
WO2017042700A1 (en) * 2015-09-07 2017-03-16 Sun Pharmaceutical Industries Limited Solid forms of valsartan and sacubitril
WO2017063581A1 (zh) * 2015-10-16 2017-04-20 深圳信立泰药业股份有限公司 一种用于心血管疾病治疗的口服制剂及其制备方法
CN105330609B (zh) * 2015-12-07 2017-12-22 南京正大天晴制药有限公司 一种制备lcz696的方法
US20190054069A1 (en) 2016-02-03 2019-02-21 Novartis Ag New use of a combination of sacubitril and valsartan
CN106176681A (zh) * 2016-08-25 2016-12-07 泰力特医药(湖北)有限公司 一种抗心脏衰竭药物lcz696口服缓释微丸及其制备方法
US11382866B2 (en) 2017-07-06 2022-07-12 Mankind Pharma Ltd. Fixed dose pharmaceutical composition of valsartan and sacubitril
US20210177803A1 (en) 2018-08-23 2021-06-17 Novartis Ag New pharmaceutical use for the treatment of heart failure
WO2020039394A1 (en) 2018-08-24 2020-02-27 Novartis Ag New drug combinations
WO2021052441A1 (zh) * 2019-09-20 2021-03-25 深圳信立泰药业股份有限公司 血管紧张素ii受体拮抗剂代谢产物与nep抑制剂的复合物治疗心衰的用途

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Publication number Priority date Publication date Assignee Title
DK0443983T3 (da) 1990-02-19 1996-03-18 Ciba Geigy Ag Acrylforbindelser
US5217996A (en) 1992-01-22 1993-06-08 Ciba-Geigy Corporation Biaryl substituted 4-amino-butyric acid amides
IL130599A0 (en) * 1997-01-10 2000-06-01 Merck & Co Inc Use of angiotensin II antagonists to treat symptomatic heart failure
CN1615134A (zh) 2002-01-17 2005-05-11 诺瓦提斯公司 含有缬沙坦和nep抑制剂的药物组合物
MXPA05012299A (es) * 2003-05-16 2006-01-30 Novartis Ag Composicion farmaceutica que comprende valsartan.
AR057882A1 (es) 2005-11-09 2007-12-26 Novartis Ag Compuestos de accion doble de bloqueadores del receptor de angiotensina e inhibidores de endopeptidasa neutra
ES2536514T3 (es) 2007-11-06 2015-05-26 Novartis Ag Composiciones farmacéuticas de doble acción basadas en superestructuras de antagonista/bloqueador de receptores de angiotensina (ARB) y receptor de endopeptidasa neutra (NEP)
HUE024872T2 (en) 2008-11-22 2016-02-29 Hoffmann La Roche Use of anti-vegf antibody in combination with chemotherapy to treat breast cancer
CA2807830C (en) * 2010-08-24 2018-04-03 Novartis Ag Treatment of hypertension and/or prevention or treatment of heart failure in a mammal receiving anti-coagulant therapy
MA37850A1 (fr) 2012-08-24 2018-07-31 Novartis Ag Inhibiteurs de nep pour le traitement de maladies caractérisées par un agrandissement atrial ou une remodélisation atriale
US20160206597A1 (en) * 2013-08-26 2016-07-21 Toni Lynne Bransford New Use

Also Published As

Publication number Publication date
PT3626270T (pt) 2024-01-11
DK3626270T3 (da) 2024-01-15
CY1122531T1 (el) 2021-01-27
RS65037B1 (sr) 2024-02-29
HRP20240034T1 (hr) 2024-03-29
EP3038654A1 (en) 2016-07-06
LT3626270T (lt) 2024-01-25
JP6097888B2 (ja) 2017-03-15
FI3626270T3 (fi) 2024-01-11
EP3626270A1 (en) 2020-03-25
HUE047186T2 (hu) 2020-04-28
EP3626270B1 (en) 2023-10-11
JP2016528303A (ja) 2016-09-15
EP3038654B1 (en) 2019-10-30
PT3038654T (pt) 2020-02-04
SI3038654T1 (sl) 2020-02-28
ES2968541T3 (es) 2024-05-10
RS59816B1 (sr) 2020-02-28
EP4321157A3 (en) 2024-05-15
DK3038654T3 (da) 2020-02-03
US20160213646A1 (en) 2016-07-28
US20210077461A1 (en) 2021-03-18
ES2767084T3 (es) 2020-06-16
EP4321157A2 (en) 2024-02-14
WO2015028941A1 (en) 2015-03-05
SI3626270T1 (sl) 2024-03-29
HUE064634T2 (hu) 2024-04-28
LT3038654T (lt) 2020-01-27
PL3038654T3 (pl) 2020-05-18
PL3626270T3 (pl) 2024-04-08

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