PL3461503T3 - Sposoby podawania tetrahydrobiopteryny, związane z nią kompozycie i sposoby pomiaru - Google Patents

Sposoby podawania tetrahydrobiopteryny, związane z nią kompozycie i sposoby pomiaru

Info

Publication number
PL3461503T3
PL3461503T3 PL18205446T PL18205446T PL3461503T3 PL 3461503 T3 PL3461503 T3 PL 3461503T3 PL 18205446 T PL18205446 T PL 18205446T PL 18205446 T PL18205446 T PL 18205446T PL 3461503 T3 PL3461503 T3 PL 3461503T3
Authority
PL
Poland
Prior art keywords
methods
measuring
associated compositions
administering tetrahydrobiopterin
tetrahydrobiopterin
Prior art date
Application number
PL18205446T
Other languages
English (en)
Inventor
Daniel I. Oppenheimer
Alejandro Dorenbaum
Augustus Okhamafe
Erik Foehr
Sianna Castillo
Paul John Kostel
Original Assignee
Biomarin Pharmaceutical Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=39620159&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=PL3461503(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Biomarin Pharmaceutical Inc. filed Critical Biomarin Pharmaceutical Inc.
Publication of PL3461503T3 publication Critical patent/PL3461503T3/pl

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0065—Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
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    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A—HUMAN NECESSITIES
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    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/4841—Filling excipients; Inactive ingredients
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    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4891—Coated capsules; Multilayered drug free capsule shells
    • A—HUMAN NECESSITIES
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    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61P25/24—Antidepressants
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    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/02—Nutrients, e.g. vitamins, minerals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/06—Antianaemics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
    • C07B63/00—Purification; Separation; Stabilisation; Use of additives
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D487/00—Heterocyclic compounds containing nitrogen atoms as the only ring hetero atoms in the condensed system, not provided for by groups C07D451/00 - C07D477/00
    • C07D487/02—Heterocyclic compounds containing nitrogen atoms as the only ring hetero atoms in the condensed system, not provided for by groups C07D451/00 - C07D477/00 in which the condensed system contains two hetero rings
    • C07D487/04—Ortho-condensed systems
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6803—General methods of protein analysis not limited to specific proteins or families of proteins
    • G01N33/6848—Methods of protein analysis involving mass spectrometry
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G01N30/62—Detectors specially adapted therefor
    • G01N30/72—Mass spectrometers
    • G01N30/7233—Mass spectrometers interfaced to liquid or supercritical fluid chromatograph
    • H—ELECTRICITY
    • H01—ELECTRIC ELEMENTS
    • H01J—ELECTRIC DISCHARGE TUBES OR DISCHARGE LAMPS
    • H01J49/00—Particle spectrometers or separator tubes
    • H01J49/004—Combinations of spectrometers, tandem spectrometers, e.g. MS/MS, MSn
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00—Chemistry: analytical and immunological testing
    • Y10T436/14—Heterocyclic carbon compound [i.e., O, S, N, Se, Te, as only ring hetero atom]
    • Y10T436/145555—Hetero-N
    • Y10T436/147777—Plural nitrogen in the same ring [e.g., barbituates, creatinine, etc.]

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Nutrition Science (AREA)
  • Hematology (AREA)
  • Physiology (AREA)
  • Molecular Biology (AREA)
  • Physics & Mathematics (AREA)
  • Dermatology (AREA)
  • Urology & Nephrology (AREA)
  • Diabetes (AREA)
  • Psychiatry (AREA)
  • Immunology (AREA)
  • Bioinformatics & Computational Biology (AREA)
  • Pain & Pain Management (AREA)
  • Obesity (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Pathology (AREA)
  • General Physics & Mathematics (AREA)
  • Biochemistry (AREA)
  • Analytical Chemistry (AREA)
  • Food Science & Technology (AREA)
  • Spectroscopy & Molecular Physics (AREA)
PL18205446T 2007-04-11 2008-04-11 Sposoby podawania tetrahydrobiopteryny, związane z nią kompozycie i sposoby pomiaru PL3461503T3 (pl)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US92282107P 2007-04-11 2007-04-11
US1975308P 2008-01-08 2008-01-08
PCT/US2008/060041 WO2008128049A2 (en) 2007-04-11 2008-04-11 Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring
EP12005352.5A EP2545939B1 (en) 2007-04-11 2008-04-11 Tetrahydrobiopterin for treating conditions associated with elevated phenylalanine levels
EP08745614A EP2139485B1 (en) 2007-04-11 2008-04-11 Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring
EP18205446.0A EP3461503B9 (en) 2007-04-11 2008-04-11 Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring

Publications (1)

Publication Number Publication Date
PL3461503T3 true PL3461503T3 (pl) 2022-05-02

Family

ID=39620159

Family Applications (3)

Application Number Title Priority Date Filing Date
PL18205446T PL3461503T3 (pl) 2007-04-11 2008-04-11 Sposoby podawania tetrahydrobiopteryny, związane z nią kompozycie i sposoby pomiaru
PL08745614T PL2139485T3 (pl) 2007-04-11 2008-04-11 Metoda podawania tetrahydrobiopteryny, powiązane kompozycje i sposoby pomiaru
PL12005352T PL2545939T3 (pl) 2007-04-11 2008-04-11 Tetrahydrobiopteryna do leczenia stanów związanych z podwyższonymi poziomami fenyloalaniny

Family Applications After (2)

Application Number Title Priority Date Filing Date
PL08745614T PL2139485T3 (pl) 2007-04-11 2008-04-11 Metoda podawania tetrahydrobiopteryny, powiązane kompozycje i sposoby pomiaru
PL12005352T PL2545939T3 (pl) 2007-04-11 2008-04-11 Tetrahydrobiopteryna do leczenia stanów związanych z podwyższonymi poziomami fenyloalaniny

Country Status (22)

Country Link
US (6) US7612073B2 (pl)
EP (4) EP3461503B9 (pl)
JP (2) JP2010523708A (pl)
KR (5) KR20100016445A (pl)
CN (1) CN101678025A (pl)
AU (1) AU2008240259C1 (pl)
BR (1) BRPI0809470A2 (pl)
CA (1) CA2682598C (pl)
CY (3) CY1113543T1 (pl)
DE (1) DE22154751T1 (pl)
DK (3) DK2139485T3 (pl)
ES (3) ES2906582T3 (pl)
HR (3) HRP20121072T1 (pl)
HU (2) HUE053107T2 (pl)
IL (1) IL201101A (pl)
LT (2) LT3461503T (pl)
MX (1) MX2009010977A (pl)
PL (3) PL3461503T3 (pl)
PT (3) PT3461503T (pl)
RU (1) RU2486899C2 (pl)
SI (2) SI3461503T1 (pl)
WO (1) WO2008128049A2 (pl)

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KR20070005550A (ko) 2003-11-17 2007-01-10 바이오마린 파머수티컬 인크. 대사 장애 치료를 위한 조성물 및 방법
SI3461503T1 (sl) 2007-04-11 2022-04-29 Biomarin Pharmaceutical Inc. Postopki za dajanje tetrahidrobiopterina, povezani sestavki in postopki merjenja
US20110144117A1 (en) * 2008-08-12 2011-06-16 Orpha Swiss Gmbh Pharmaceutical Dosage Form Containing Tetrahydrobiopterin
US9089573B2 (en) * 2009-07-22 2015-07-28 University Of Massachusetts Methods and compositions to reduce oxidative stress
US20130197000A1 (en) * 2010-04-22 2013-08-01 Nihon University Drug and food/drink for preventing or improving cerebral dysfunction
PL3222280T3 (pl) * 2010-12-03 2021-11-29 Nalpropion Pharmaceuticals Llc Wzrost biodostępności leku w terapii naltreksonem
KR20140021585A (ko) * 2011-03-01 2014-02-20 루비콘 리서치 피브이티. 엘티디. 테트라하이드로바이옵테린의 안정한 조성물
WO2013063163A1 (en) * 2011-10-24 2013-05-02 Kickass Candy, Llc Sweet tart energy tablet
US9216178B2 (en) * 2011-11-02 2015-12-22 Biomarin Pharmaceutical Inc. Dry blend formulation of tetrahydrobiopterin
SMT202000008T1 (it) 2012-01-23 2020-03-13 Sage Therapeutics Inc Formulazione di steroide neuroattivo comprendente un complesso di allopregnanolone e solfobutil eter beta-ciclodestrina
US11918557B2 (en) 2012-01-26 2024-03-05 Vanda Pharmaceuticals Inc. Treatment of circadian rhythm disorders
CA3085116C (en) 2012-01-26 2022-07-19 Vanda Pharmaceuticals Inc. Treatment of circadian rhythm disorders
CN102650621B (zh) * 2012-05-02 2014-06-25 安徽农业大学 一种从蚕体提取的墨蝶呤的鉴定方法
PL2887944T3 (pl) 2012-08-21 2022-02-21 Sage Therapeutics, Inc. Allopregnanolon do leczenia lekoopornego stanu padaczkowego
KR20150119009A (ko) * 2013-02-08 2015-10-23 유니버시티 오브 아이오와 리써치 파운데이션 자간전증의 개시를 예측하기 위한 진단 기구
US10376487B2 (en) 2013-11-12 2019-08-13 Vanda Pharmaceuticals Inc. Method of treatment
US11090285B2 (en) 2013-11-12 2021-08-17 Vanda Pharmaceuticals Inc Treatment of circadian rhythm disorders
US20150204834A1 (en) * 2014-01-22 2015-07-23 Sarfaraz K. Niazi Thermodynamic equivalence surrogate test (test) for bioequivalence
PL2926805T3 (pl) * 2014-03-31 2016-12-30 Stałe kompozycje farmaceutyczne zawierające pochodne biopteryny oraz zastosowania takich kompozycji
JOP20200195A1 (ar) 2014-09-08 2017-06-16 Sage Therapeutics Inc سترويدات وتركيبات نشطة عصبياً، واستخداماتها
MA41124A (fr) * 2014-12-05 2017-10-10 Sun Pharmaceutical Ind Ltd Compositions en suspension à libération prolongée à rétention gastrique
JP6996713B2 (ja) 2015-10-06 2022-02-04 エイチエルビー・セラピューティクス・カンパニー・リミテッド チモシンベータ４を含む眼科用製剤の製造方法
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