Found: 46
Select item for more details and to access through your institution.
Equivalence of complex drug products: advances in and challenges for current regulatory frameworks.
- Published in:
- Annals of the New York Academy of Sciences, 2017, v. 1407, n. 1, p. 39, doi. 10.1111/nyas.13347
- By:
- Publication type:
- Article
Cryogenic Transmission Electron Microscopy (Cryo-TEM) Reveals Morphological Changes of Liposomal Doxorubicin during In Vitro Release.
- Published in:
- Microscopy & Microanalysis, 2017, v. 23, p. 1216, doi. 10.1017/S1431927617006742
- By:
- Publication type:
- Article
Stem cell-derived cardiomyocytes expressing a dominant negative pacemaker HCN4 channel do not reduce the risk of graft-related arrhythmias.
- Published in:
- Frontiers in Cardiovascular Medicine, 2024, p. 01, doi. 10.3389/fcvm.2024.1374881
- By:
- Publication type:
- Article
The Effect of Excipients on the Permeability of BCS Class III Compounds and Implications for Biowaivers.
- Published in:
- Pharmaceutical Research, 2016, v. 33, n. 1, p. 167, doi. 10.1007/s11095-015-1773-4
- By:
- Publication type:
- Article
Ammonia and proinflammatory cytokines modify expression of genes coding for astrocytic proteins implicated in brain edema in acute liver failure.
- Published in:
- Metabolic Brain Disease, 2010, v. 25, n. 1, p. 17, doi. 10.1007/s11011-010-9185-y
- By:
- Publication type:
- Article
Portacaval anastomosis-induced hyperammonemia does not lead to oxidative stress.
- Published in:
- Metabolic Brain Disease, 2010, v. 25, n. 1, p. 11, doi. 10.1007/s11011-010-9174-1
- By:
- Publication type:
- Article
Direct evidence for central proinflammatory mechanisms in rats with experimental acute liver failure: protective effect of hypothermia.
- Published in:
- Journal of Cerebral Blood Flow & Metabolism, 2009, v. 29, n. 5, p. 944, doi. 10.1038/jcbfm.2009.18
- By:
- Publication type:
- Article
Role of anti-inflammatory compounds in human immunodeficiency virus-1 glycoprotein120-mediated brain inflammation.
- Published in:
- Journal of Neuroinflammation, 2014, v. 11, n. 1, p. 1, doi. 10.1186/1742-2094-11-91
- By:
- Publication type:
- Article
Role of anti-inflammatory compounds in human immunodeficiency virus-1 glycoprotein120-mediated brain inflammation.
- Published in:
- 2014
- By:
- Publication type:
- journal article
Evaluation of Switching Patterns in FDA's Sentinel System: A New Tool to Assess Generic Drugs.
- Published in:
- 2018
- By:
- Publication type:
- journal article
Development of In Vitro Dissolution Testing Methods to Simulate Fed Conditions for Immediate Release Solid Oral Dosage Forms.
- Published in:
- AAPS Journal, 2022, v. 24, n. 2, p. 1, doi. 10.1208/s12248-022-00690-5
- By:
- Publication type:
- Article
Report of the AAPS Guidance Forum on the FDA Draft Guidance for Industry: "Drug Products, Including Biological Products, that Contain Nanomaterials".
- Published in:
- AAPS Journal, 2019, v. 21, n. 4, p. N.PAG, doi. 10.1208/s12248-019-0329-7
- By:
- Publication type:
- Article
In vitro Approaches to Support Bioequivalence and Substitutability of Generic Proton Pump Inhibitors via Nasogastric Tube Administration.
- Published in:
- AAPS Journal, 2017, v. 19, n. 6, p. 1593, doi. 10.1208/s12248-017-0137-x
- By:
- Publication type:
- Article
How Has CDER Prepared for the Nano Revolution? A Review of Risk Assessment, Regulatory Research, and Guidance Activities.
- Published in:
- AAPS Journal, 2017, v. 19, n. 4, p. 1071, doi. 10.1208/s12248-017-0084-6
- By:
- Publication type:
- Article
Scientific and Regulatory Considerations for Generic Complex Drug Products Containing Nanomaterials.
- Published in:
- AAPS Journal, 2017, v. 19, n. 3, p. 619, doi. 10.1208/s12248-017-0044-1
- By:
- Publication type:
- Article
Development of a Flow-Through USP-4 Apparatus Drug Release Assay to Evaluate Doxorubicin Liposomes.
- Published in:
- AAPS Journal, 2017, v. 19, n. 1, p. 150, doi. 10.1208/s12248-016-9958-2
- By:
- Publication type:
- Article
Erratum to: A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion.
- Published in:
- 2015
- By:
- Publication type:
- Erratum
A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion.
- Published in:
- AAPS Journal, 2015, v. 17, n. 4, p. 891, doi. 10.1208/s12248-015-9753-5
- By:
- Publication type:
- Article
CDER Risk Assessment Exercise to Evaluate Potential Risks from the Use of Nanomaterials in Drug Products.
- Published in:
- AAPS Journal, 2013, v. 15, n. 3, p. 623, doi. 10.1208/s12248-013-9466-6
- By:
- Publication type:
- Article
Global harmonization of immediate‐release solid oral drug product bioequivalence recommendations and the impact on generic drug development.
- Published in:
- CTS: Clinical & Translational Science, 2023, v. 16, n. 12, p. 2756, doi. 10.1111/cts.13670
- By:
- Publication type:
- Article
Formaldehyde-mediated aggregation of protein antigens: Comparison of untreated and formalinized model antigens.
- Published in:
- Biotechnology & Bioengineering, 2000, v. 70, n. 5, p. 507, doi. 10.1002/1097-0290(20001205)70:5<507::AID-BIT5>3.0.CO;2-C
- By:
- Publication type:
- Article
Ghost-Pill-Buster: A Case Study of Intact Levetiracetam Extended-Release Tablets after Dissolution Testing.
- Published in:
- 2016
- By:
- Publication type:
- journal article
Bioequivalence between innovator and generic tacrolimus in liver and kidney transplant recipients: A randomized, crossover clinical trial.
- Published in:
- 2017
- By:
- Publication type:
- journal article
Comparative Evaluation of U.S. Brand and Generic Intravenous Sodium Ferric Gluconate Complex in Sucrose Injection: Physicochemical Characterization.
- Published in:
- Nanomaterials (2079-4991), 2018, v. 8, n. 1, p. 25, doi. 10.3390/nano8010025
- By:
- Publication type:
- Article
Comparative Evaluation of U.S. Brand and Generic Intravenous Sodium Ferric Gluconate Complex in Sucrose Injection: Biodistribution after Intravenous Dosing in Rats.
- Published in:
- Nanomaterials (2079-4991), 2018, v. 8, n. 1, p. 10, doi. 10.3390/nano8010010
- By:
- Publication type:
- Article
Comparative Evaluation of U.S. Brand and Generic Intravenous Sodium Ferric Gluconate Complex in Sucrose Injection: In Vitro Cellular Uptake.
- Published in:
- Nanomaterials (2079-4991), 2017, v. 7, n. 12, p. 451, doi. 10.3390/nano7120451
- By:
- Publication type:
- Article
Correction to: Outcomes Associated with Generic Drugs Approved Using Product-Specific Determinations of Therapeutic Equivalence.
- Published in:
- Drugs, 2018, v. 78, n. 4, p. 523, doi. 10.1007/s40265-018-0890-x
- By:
- Publication type:
- Article
Dissolution Test of Tacrolimus Capsule: Effects of Filtration and Glass Adsorption.
- Published in:
- AAPS PharmSciTech, 2018, v. 19, n. 2, p. 961, doi. 10.1208/s12249-017-0856-4
- By:
- Publication type:
- Article
Preferences for and Experiences With Pill Appearance Changes: National Surveys of Patients and Pharmacists.
- Published in:
- American Journal of Managed Care, 2020, v. 26, n. 8, p. 340, doi. 10.37765/ajmc.2020.44070
- By:
- Publication type:
- Article
SNRPB promotes cell cycle progression in thyroid carcinoma via inhibiting p53.
- Published in:
- Open Medicine, 2022, v. 17, n. 1, p. 1623, doi. 10.1515/med-2022-0531
- By:
- Publication type:
- Article
Outcomes Associated with Generic Drugs Approved Using Product-Specific Determinations of Therapeutic Equivalence.
- Published in:
- Drugs, 2017, v. 77, n. 4, p. 427, doi. 10.1007/s40265-017-0696-2
- By:
- Publication type:
- Article
Research and Education Needs for Complex Generics.
- Published in:
- Pharmaceutical Research, 2021, v. 38, n. 12, p. 1991, doi. 10.1007/s11095-021-03149-y
- By:
- Publication type:
- Article
Lack of Association of Generic Brittle Status with Genetics and Physiologic Measures in Patients with Epilepsy.
- Published in:
- Pharmaceutical Research, 2020, v. 37, n. 3, p. 1, doi. 10.1007/s11095-020-2781-6
- By:
- Publication type:
- Article
Considerations for the Forced Expiratory Volume in 1 Second‐Based Comparative Clinical Endpoint Bioequivalence Studies for Orally Inhaled Drug Products.
- Published in:
- Clinical Pharmacology & Therapeutics, 2022, v. 112, n. 5, p. 982, doi. 10.1002/cpt.2553
- By:
- Publication type:
- Article
Assessing Physician and Patient Perceptions of Generic Drugs via Facebook: A Feasibility Study.
- Published in:
- Journal of Pharmacy Technology, 2018, v. 34, n. 2, p. 43, doi. 10.1177/8755122517747906
- By:
- Publication type:
- Article
Mixed and Matched Metallo‐Nanotexaphyrin for Customizable Biomedical Imaging.
- Published in:
- Advanced Healthcare Materials, 2019, v. 8, n. 6, p. N.PAG, doi. 10.1002/adhm.201800857
- By:
- Publication type:
- Article
Risk-Based Bioequivalence Recommendations for Antiepileptic Drugs.
- Published in:
- Current Neurology & Neuroscience Reports, 2017, v. 17, n. 11, p. 1, doi. 10.1007/s11910-017-0795-1
- By:
- Publication type:
- Article
Switch-backs associated with generic drugs approved using product-specific determinations of therapeutic equivalence.
- Published in:
- Pharmacoepidemiology & Drug Safety, 2016, v. 25, n. 8, p. 944, doi. 10.1002/pds.4009
- By:
- Publication type:
- Article
Generic lamotrigine extended‐release tablets are bioequivalent to innovator drug in fully replicated crossover bioequivalence study.
- Published in:
- Epilepsia (Series 4), 2023, v. 64, n. 1, p. 152, doi. 10.1111/epi.17438
- By:
- Publication type:
- Article
Synergistic effect of vincristine with tacrolimus or sirolimus in prevention of acute heart allograft rejection in the rat.
- Published in:
- Microsurgery, 2003, v. 23, n. 2, p. 117, doi. 10.1002/micr.10099
- By:
- Publication type:
- Article
Restoration of fertility in oophorectomized rats after tubo-ovarian transplantation.
- Published in:
- Microsurgery, 2002, v. 22, n. 1, p. 30, doi. 10.1002/micr.22006
- By:
- Publication type:
- Article
Generic lamotrigine versus brand-name Lamictal bioequivalence in patients with epilepsy: A field test of the FDA bioequivalence standard.
- Published in:
- Epilepsia (Series 4), 2015, v. 56, n. 9, p. 1415, doi. 10.1111/epi.13095
- By:
- Publication type:
- Article
Bioequivalence Between Generic and Branded Lamotrigine in People With Epilepsy : The EQUIGEN Randomized Clinical Trial.
- Published in:
- JAMA Neurology, 2017, v. 74, n. 8, p. 919, doi. 10.1001/jamaneurol.2017.0497
- By:
- Publication type:
- Article
A Survey of Patients' Perceptions of Pill Appearance and Responses to Changes in Appearance for Four Chronic Disease Medications.
- Published in:
- 2019
- By:
- Publication type:
- journal article
Cerebral inflammation contributes to encephalopathy and brain edema in acute liver failure: protective effect of minocycline.
- Published in:
- Journal of Neurochemistry, 2009, v. 109, n. 2, p. 485, doi. 10.1111/j.1471-4159.2009.05981.x
- By:
- Publication type:
- Article
Generic Versions of Narrow Therapeutic Index Drugs: A National Survey of Pharmacists' Substitution Beliefs and Practices.
- Published in:
- Clinical Pharmacology & Therapeutics, 2018, v. 103, n. 6, p. 1093, doi. 10.1002/cpt.884
- By:
- Publication type:
- Article