The bioequivalence study design recommendations for immediate-release solid oral dosage forms in the international pharmaceutical regulators programme participating regulators and organisations: differences and commonalities.

Autor: Fernandes EAF; Agência Nacional de Vigilância Sanitária, Brasília, Brazil., van Oudtshoorn J; South African Health Products Regulatory Authority, Pretoria, South Africa., Tam A; Health Canada, Ottawa, ON, Canada., González LCA; Instituto Nacional de Vigilancia de Medicamentos y Alimentos, Bogota, Colombia., Aurela EG; Instituto Nacional de Vigilancia de Medicamentos y Alimentos, Bogota, Colombia., Potthast H; Federal Institute for Drugs and Medical Devices, Bonn, Germany., Mettke K; Federal Institute for Drugs and Medical Devices, Bonn, Germany., Kuribayashi R; Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency, Tokyo, Japan., Shimojo K; Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency, Tokyo, Japan., Kasuga M; Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency, Tokyo, Japan., Morales L; Comisión Federal para la Protección contra Riesgos Sanitarios, Ciudad de Mexico, México., Rodríguez Z; Comisión Federal para la Protección contra Riesgos Sanitarios, Ciudad de Mexico, México., Jones B; Medsafe, Wellington, New Zealand., Ahn C; Ministry of Food and Drug Safety, Cheongju-si, Republic of Korea., Yun E; Ministry of Food and Drug Safety, Cheongju-si, Republic of Korea., Kim SH; Ministry of Food and Drug Safety, Cheongju-si, Republic of Korea., Rodrigues C; Health Sciences Authority, Singapore, Singapore., Tiong T; Health Sciences Authority, Singapore, Singapore., Crane C; Therapeutic Goods Administration, Canberra, NSW, Australia., Walther C; Swissmedic, Bern, Switzerland., Roost MS; Swissmedic, Bern, Switzerland., Chen TL; Taiwan Food and Drug Administration, Taipei, Taiwan., Hsu LF; Center for Drug Evaluation, Taipei, Taiwan., Braddy AC; Food and Drug Administration, Silver Spring, MD, United States., García-Arieta A; WHO-Observer, Geneva, Switzerland.; Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain., Abalos I; Administración Nacional de Medicamentos, Alimentos y Tecnología, Buenos Aires, Argentina., Divinsky M; Center for Pharmaceutical and Enforcement Division, Jerusalem, Israel., Alsuwyeh A; Saudi Food and Drug Authority, Riyadh, Saudi Arabia., Alzenaidy B; Saudi Food and Drug Authority, Riyadh, Saudi Arabia., Alharf A; Saudi Food and Drug Authority, Riyadh, Saudi Arabia.

Publikováno v: Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques [J Pharm Pharm Sci] 2024 Mar 21; Vol. 27, pp. 12398. Date of Electronic Publication: 2024 Mar 21 (Print Publication: 2024).

Predictors of Intervention Adherence in Compensatory Cognitive Training for Veterans With a History of Mild Traumatic Brain Injury.

Autor: Mahmood Z; SDSU/UC San Diego Joint Doctoral Program in Clinical Psychology, San Diego, California (Ms Mahmood); Research Service (Ms Mahmood and Dr Twamley), Center of Excellence for Stress and Mental Health (Drs Clark, Jak and Twamley), and Psychology Service (Dr Jak), VA San Diego Healthcare System, San Diego, California; Department of Psychiatry, University of California San Diego (Drs Clark, Jak and Twamley); VA Portland Health Care System, Portland, Oregon (Drs Huckans, O'Neil, Roost, and Storzbach); Departments of Psychiatry (Drs Huckans, O'Neil, and Storzbach), Medical Informatics and Clinical Epidemiology (Dr O'Neil), and Neurology (Dr Storzbach), Oregon Health & Science University, Portland; VA Puget Sound Health Care System, Seattle, Washington (Drs Williams, Pagulayan and Turner); and Departments of Rehabilitation Medicine (Drs Williams and Turner) and Psychiatry and Behavioral Sciences (Dr Pagulayan), University of Washington School of Medicine, Seattle., Clark JMR, Jak AJ, Huckans M, O'Neil ME, Roost MS, Williams RM, Pagulayan KF, Turner AP, Storzbach D, Twamley EW

Publikováno v: The Journal of head trauma rehabilitation [J Head Trauma Rehabil] 2021 Jan-Feb 01; Vol. 36 (1), pp. 20-24.

Organoids and organoid extracellular vesicles-based disease treatment strategies.

Autor: Zhou, Guangyin^1,2,3 (AUTHOR), Li, Ruiyang^2,4 (AUTHOR), Sheng, Shihao⁴ (AUTHOR), Huang, Jingtao⁵ (AUTHOR), Zhou, Fengjin⁶ (AUTHOR) xarcsh@164.com, Wei, Yan^1,2,3 (AUTHOR) ywei@shu.edu.cn, Liu, Han^1,2,3,4 (AUTHOR) liuhanqiu@shu.edu.cn, Su, Jiacan^1,2,3,4 (AUTHOR) drsujiacan@163.com

Publikováno v: Journal of Nanobiotechnology. 11/6/2024, Vol. 22 Issue 1, p1-21. 21p.

Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities.

Autor: Roost MS; Swissmedic, Schweizerisches Heilmittelinstitut, Bern, Switzerland., Potthast H; 2European Medicines Agency's (EMA) Pharmacokinetics Working Party and Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Bonn, Germany., Walther C; Swissmedic, Schweizerisches Heilmittelinstitut, Bern, Switzerland., García-Arieta A; WHO Prequalification of Medicines Programme, and Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Madrid, Spain., Abalos I; Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT), Ciudad Autónoma de Buenos Aires, Argentina., Agostinho Freitas Fernandes E, Mendes Lima Santos G; Agência Nacional de Vigilância Sanitária (ANVISA), Brasília, Brazil; 8Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), Ciudad de México, Mexico., Rodríguez Martínez Z; Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), Ciudad de México, Mexico., Tam A; Health Canada, Ottawa, Ontario, Canada., Rodrigues C; Health Sciences Authority, Health Products Regulation Group, Pre-Marketing Cluster, Therapeutic Products Branch, Singapore, Singapore., Gutierrez Triana DA; Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA), Bogotá. Colombia., Guzmán Aurela E; Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA), Bogotá. Colombia., Rodríguez Rodríguez N; Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA), Bogotá. Colombia., Aeh Park S; Ministry of Food and Drug Safety, Osong-eup Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, Republic of Korea., Kim J; Ministry of Food and Drug Safety, Osong-eup Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, Republic of Korea., Kariv R; Ministry of Health (Israel), Pharmaceutical Division, Jerusalem., Divinsky M; Ministry of Health (Israel), Pharmaceutical Division, Jerusalem., Jones B; New Zealand Medicines and Medical Devices Safety Authority (Medsafe), Ministry of Health, Thorndon, Wellington, New Zealand., Kuribayashi R; Pharmaceuticals and Medical Devices Agency (PMDA), Kasumigaseki, Chiyoda-ku, Tokyo, Japan., Myoenzono A; Pharmaceuticals and Medical Devices Agency (PMDA), Kasumigaseki, Chiyoda-ku, Tokyo, Japan., Kasuga M; Pharmaceuticals and Medical Devices Agency (PMDA), Kasumigaseki, Chiyoda-ku, Tokyo, Japan., Van Oudtshoorn J; South African Health Products Regulatory Authority (SAHPRA), Loftus Park, Arcadia, Pretoria, South Africa., Chi JF, Hung WY; Taiwan Food and Drug Administration (TFDA), Nangang, Taipei, Taiwan, R.O.C., Hsu LF; Center for Drug Evaluation (CDE), Taipei, Taiwan R.O.C., Crane C; Therapeutic Goods Administration (TGA), Woden, Australia., Jarman T; Therapeutic Goods Administration (TGA), Woden, Australia., Braddy A; U.S. Department of Health and Human Services, Food and Drug Administration (USFDA), Center for Drug Evaluation and Research, Office of Generic Drugs, Silver Spring, Maryland, USA.

Publikováno v: Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques [J Pharm Pharm Sci] 2021; Vol. 24, pp. 548-562.

A suboptimal OCT4-SOX2 binding site facilitates the naïve-state specific function of a Klf4 enhancer.

Autor: Waite, Jack B.¹ (AUTHOR), Boytz, RuthMabel² (AUTHOR), Traeger, Alexis R.¹ (AUTHOR), Lind, Torrey M.¹ (AUTHOR), Lumbao-Conradson, Koya¹ (AUTHOR), Torigoe, Sharon E.^1,2 (AUTHOR) torigoe@lclark.edu

Publikováno v: PLoS ONE. 9/30/2024, Vol. 19 Issue 9, p1-24. 24p.