about
Approval of a Tuberculosis Drug Based on a Paradoxical Surrogate MeasureAdapting Drug Approval Pathways for Bacteriophage-Based TherapeuticsDrug-loaded erythrocytes: on the road toward marketing approvalA survey of new oncology drug approvals in the USA from 2010 to 2015: a focus on optimal dose and related postmarketing activitiesCharacteristics of efficacy evidence supporting approval of supplemental indications for prescription drugs in United States, 2005-14: systematic reviewNon-Alcoholic Steatohepatitis: Limited Available Treatment Options but Promising Drugs in Development and Recent Progress Towards a Regulatory Approval PathwayEnding the 50-year drought of FDA drug approval for SLESurvey of international regulatory bioequivalence recommendations for approval of generic topical dermatological drug productsNeoadjuvant therapy as a platform for drug development and approval in breast cancerBreast cancer in 2013: Genomics, drug approval, and optimal treatment durationU.S. Food and Drug Administration: Review for the Emergency Physician of Approval Process and LimitationsFast-track drug approval in inflammatory bowel diseasesRole of patient-reported outcomes and other efficacy endpoints in the drug approval process in Europe (2008-2012)Pfizer accused of testing new drug without ethical approvalThe safety and efficacy of new drug approvalRisk assessment, drug approval, and liabilityU.S. Food and Drug Administration drug approval: slow advances in obstetric care in the United StatesApproval times for new drugs: does the source of funding for FDA staff matter?Breakthrough Drug Approval Process and Postmarketing ADR ReportingFast tracking drugs to patients. Drug approval agencies are frequently criticised for either being too slow or too fast.Financing of U.S. biomedical research and new drug approvals across therapeutic areasA new approach to psychiatric drug approval in EuropeUse of Fixed Dose Combination (FDC) Drugs in India: Central Regulatory Approval and Sales of FDCs Containing Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), Metformin, or Psychotropic DrugsFixed-Dose Combination Drug Approvals, Patents and Market Exclusivities Compared to Single Active Ingredient PharmaceuticalsPhysicians' Trust in the FDA's Use of Product-Specific Pathways for Generic Drug ApprovalThe potential risks of expedited approval of drugs for acute bacterial infectionsRecent new drug approvals. Part 1: drugs with pediatric indicationsThe Role of Health-Related Quality of Life Data in the Drug Approval Processes in the US and EuropeApproval of Raxibacumab for the Treatment of Inhalation Anthrax Under the US Food and Drug Administration "Animal Rule".A look backward and forward in the regulatory and treatment history of multiple myeloma: Approval of novel-novel agents, new drug development, and longer patient survival.US Food and Drug Administration Approval of Liposomal Amphotericin B for the Treatment of Visceral Leishmaniasis: A Model for Orphan Drug Development.Accelerating drug development and approval.Have thoracic endografting outcomes improved since US Food and Drug Administration approval?A survey of renal impairment pharmacokinetic studies for new oncology drug approvals in the USA from 2010 to early 2015: a focus on development strategies and future directionsRegulatory approval of cancer risk-reducing (chemopreventive) drugs: moving what we have learned into the clinicDeveloping data to satisfy drug and pesticide approval requirements of FDA, EPA, and USDA; are cattle, sheep, and poultry minor species?Recommendations for the development of rare disease drugs using the accelerated approval pathway and for qualifying biomarkers as primary endpoints.A role for two-stage pharmacoeconomic appraisal? Is there a role for interim approval of a drug for reimbursement based on modelling studies with subsequent full approval using phase III data?The Power of the Patient Voice: Formalising Qualitative Data in the Drug Approval Process.Drug approval summaries: arsenic trioxide, tamoxifen citrate, anastrazole, paclitaxel, bexarotene.
P921
Q22253009-35449279-3842-4F19-B862-D78BE7D3603EQ26740597-FAED9CD4-0814-4084-AEE9-937AE353E878Q26765322-41FC46ED-87E5-47BF-8DC0-7B77B91A0D88Q26774752-EABE4CC2-FC76-4751-84A6-55EABE68BBD7Q26781716-CCE6917A-D7EE-48F7-974C-EECC81AE7D03Q26800894-B7D4FFDA-DE63-458D-8455-090461B7918BQ26823341-EFC3EA85-C617-4FB3-868D-0A31A3C6C12DQ26823829-55A6AF8D-85A0-43C9-A659-4224BE6EDBF8Q26865800-FA22FC5A-BE39-4701-B492-3EBE7C3D40D5Q27021514-6971D28C-7F83-40C2-891A-B9BE5B9DA887Q28072494-52E40E34-EE13-4ADD-B06A-26B8B3FE44EFQ28077510-C8D593C7-2034-428F-B422-13C680B5A908Q28085357-40699141-1072-4B07-9DFF-214A8C349C02Q28142868-685E6CA5-F0AD-418D-B0F2-0B7F631904E4Q28200728-FB24797C-D026-4087-A920-2DFCA27C48FEQ28219056-28EE31B9-9CAB-4511-AC16-D5EF9B076A72Q28277353-5328E317-6C6A-4809-AAA1-7322911FAD8BQ28289812-0D70C981-1190-424D-B1FD-A763D87FEA1FQ28305779-B0BCDE71-AB02-4649-B537-EE0029D51B32Q28345293-4FAD0E7D-D807-4995-B15C-84E2A4B95D86Q28476113-CC18B101-9152-40C7-892B-51ADADBEAE45Q28534418-6AA700F5-7383-4DEF-A4F3-7EDEDC60F52DQ28547181-057BFA67-3E16-4275-A11C-963473C1D8B6Q28550319-B73C8EFA-9CE0-425F-9259-47B4BF2FA46CQ28552883-5E52D5D7-9DDA-426D-B862-06CBB165E25AQ28652185-291F5471-A15D-46B8-9AEC-AFFBC60A6155Q28709081-9D9008A8-86E5-44F5-92D0-B996BB7261CEQ29013209-D6DF67ED-0EC2-41B6-A1B1-173905679D92Q30201937-1D10F77D-F261-45BE-9818-AD3AD0567F13Q30239781-C568FF47-C102-4F3C-969A-6DE86D17FE4CQ30306478-6ECB8BE4-D76A-42B6-9A5B-F0BDBC2C2B3AQ30385630-402286EA-1AD6-48D3-8665-450F3899D633Q30427041-93BE7FC7-75C7-4767-A7EF-EDBECD9F9A89Q30491777-96B5B071-70D0-4E5C-91F9-EEE2D16B9BD4Q30498812-158A8785-D12A-44EA-AF98-9379DA0A2A1FQ30592637-46C76CCA-FA67-45B5-B897-42845678A579Q30624174-7B74DEE1-5A41-4FF2-9699-7ED3CF45F48EQ30811686-48C32EB7-1F57-4254-BF49-33F94ED4A9C8Q31017156-2EC99B7B-325E-4B68-803C-C46336F635AFQ31846192-93868D3A-D9E1-41C7-A6C4-B82FFBCFDC1C
P921
description
permission for a pharmaceutica ...... ons in a specific jurisdiction
@en
特定の管轄区域における特定の症例に対して使用するために医薬品を販売するための許可
@ja
name
aprobo de medikamento
@eo
aprovació de medicament
@ca
drug approval
@en
医薬品承認
@ja
type
label
aprobo de medikamento
@eo
aprovació de medicament
@ca
drug approval
@en
医薬品承認
@ja
prefLabel
aprobo de medikamento
@eo
aprovació de medicament
@ca
drug approval
@en
医薬品承認
@ja