Journal articles on the topic 'Marketing Authorization Application'
Create a spot-on reference in APA, MLA, Chicago, Harvard, and other styles
Consult the top 50 journal articles for your research on the topic 'Marketing Authorization Application.'
Next to every source in the list of references, there is an 'Add to bibliography' button. Press on it, and we will generate automatically the bibliographic reference to the chosen work in the citation style you need: APA, MLA, Harvard, Chicago, Vancouver, etc.
You can also download the full text of the academic publication as pdf and read online its abstract whenever available in the metadata.
Browse journal articles on a wide variety of disciplines and organise your bibliography correctly.
Slevin, Lindi, Reza Shojanoori, and Radmila Juric. "DEVELOPING A DATABASE FOR AUTOMATING REGULATORY AFFAIRS IN THE PHARMACEUTICAL INDUSTRY." Journal of Integrated Design and Process Science: Transactions of the SDPS, Official Journal of the Society for Design and Process Science 9, no. 4 (2005): 1–11. http://dx.doi.org/10.3233/jid-2005-9401.
Full textC., Bhave, Dolhare N., and J. K. Badjatya. "MARKETING AUTHORIZATION APPLICATION (MAA) FOR EUROPE MARKET." International Journal of Drug Regulatory Affairs 3, no. 1 (2018): 88–91. http://dx.doi.org/10.22270/ijdra.v3i1.160.
Full textSathyalakshmi Ramesh and Sowmya Cherukuri. "The European Union’s current regulations for the licensing of generic and hybrid medications." World Journal of Biology Pharmacy and Health Sciences 13, no. 2 (2023): 105–10. http://dx.doi.org/10.30574/wjbphs.2023.13.2.0233.
Full textSathyalakshmi, Ramesh, and Cherukuri Sowmya. "The European Union's current regulations for the licensing of generic and hybrid medications." World Journal of Biology Pharmacy and Health Sciences 13, no. 2 (2023): 105–10. https://doi.org/10.5281/zenodo.7948643.
Full textCarmo, Ana Cerúlia Moraes do, Stefânia Schimaneski Piras, Nayrton Flávio Moura Rocha, and Tais Gratieri. "Main Reasons for Registration Application Refusal of Generic and Similar Pharmaceutical Drug Products by the Brazilian Health Regulatory Agency (ANVISA)." BioMed Research International 2017 (2017): 1–10. http://dx.doi.org/10.1155/2017/7894937.
Full textGupta, Rajkumar. "INSIDE STORY FOR REVIEW OF AN ABBREVIATED NEW DRUG APPLICATION." International Journal of Drug Regulatory Affairs 2, no. 1 (2018): 29–31. http://dx.doi.org/10.22270/ijdra.v2i1.122.
Full textD., Sarika Prathyusha* Brahmaiah Bonthagarala M.V. Ngabhushanam and D. Nagarjuna Reddy. "MARKETING AUTHORIZATION PROCESS OF NEW DRUG SUBSTANCES IN U.S.A AND EUROPE." Indo American Journal of Pharmaceutical Sciences 04, no. 06 (2017): 1690–98. https://doi.org/10.5281/zenodo.821854.
Full textChakraborty, Krishnasis. "A New Drug Approval Process in Europe: A Review." International Journal of Drug Regulatory Affairs 7, no. 3 (2019): 21–29. http://dx.doi.org/10.22270/ijdra.v7i3.332.
Full textHaishi, Yu, Jiang Yingzhu, and Zhou Weijun. "Status Analysis on the Marketing Authorization Holder of China's Drugs." E3S Web of Conferences 185 (2020): 04009. http://dx.doi.org/10.1051/e3sconf/202018504009.
Full textKelly, L., M. Lazzaro, and C. Petersen. "Canadian Drug Regulatory Framework." Canadian Journal of Neurological Sciences / Journal Canadien des Sciences Neurologiques 34, S1 (2007): S3—S10. http://dx.doi.org/10.1017/s0317167100005485.
Full textHomeniuk, Anastasiia. "Key issues of legal regulation of the supplementary protection of inventions in the field of pharmacy in the national legislation of Ukraine." Theory and Practice of Intellectual Property, no. 6 (December 27, 2021): 111–19. http://dx.doi.org/10.33731/62021.249108.
Full textEmbleton-Thirsk, Andrew, Elizabeth Deane, Stephen Townsend, et al. "Impact of retrospective data verification to prepare the ICON6 trial for use in a marketing authorization application." Clinical Trials 16, no. 5 (2019): 502–11. http://dx.doi.org/10.1177/1740774519862528.
Full textGjeorgiev, Blagoj, Dijana Miceva, Dino Karpicarov, et al. "A comparative study of the procedures for medicine approval in the European Union and the United States." Arhiv za farmaciju 75, no. 2 (2025): 101–13. https://doi.org/10.5937/arhfarm75-55555.
Full textJachimowicz, Michał, Cezary Pruszko, and Karolina Dziadek. "PD205 “Medical Fund” – A Novel Approach To Granting Individuals Access To Cutting-Edge Therapies." International Journal of Technology Assessment in Health Care 40, S1 (2024): S171. https://doi.org/10.1017/s0266462324004276.
Full textParth, Killedar* Tanuja Khopade Siddhi Kurhade Nutan Kokare Shubhangi Khemnar S. D. Mankar. "Comparative Study of Regulatory Requirements for Drug Approval (USFDA vs. EMA vs. INDIA)." International Journal of Pharmaceutical Sciences 3, no. 4 (2025): 3002–13. https://doi.org/10.5281/zenodo.15276998.
Full textChamberlain, Paul. "Effective presentation of immunogenicity risk assessments and related data in regulatory dossiers." Bioanalysis 11, no. 17 (2019): 1581–92. http://dx.doi.org/10.4155/bio-2018-0209.
Full textYadav, Dr N. Sudhakar, Dr Ch Mallikarjuna Rao, Dr D. V. Lalitha Parameswari, Dr K. L. S. Soujanya, and Dr Challa Madhavi Latha. "Accessing Cloud Services Using Token based Framework for IoT Devices." Webology 18, no. 2 (2021): 199–211. http://dx.doi.org/10.14704/web/v18i2/web18316.
Full textLino, Maria Maddalena, Susan Mather, Marianna Trani, Yan Chen, Patrick Caubel, and Barbara De Bernardi. "Challenges and Innovations in Pharmacovigilance and Signal Management During the COVID-19 Pandemic: An Industry Perspective." Vaccines 13, no. 5 (2025): 481. https://doi.org/10.3390/vaccines13050481.
Full textMcKenna, Kevin. "An Overview and Comparison of the US and EEC Chemical and Pharmaceutical Requirements for the Marketing Authorization/New Drug Application." Drug Information Journal 23, no. 3 (1989): 371–77. http://dx.doi.org/10.1177/009286158902300307.
Full textNoguera Peña, Alfonso. "Innovation in the future Pharmaceutical Legislation of the European Union." Anales de la Real Academia Nacional de Farmacia 90, no. 90(04) (2025): 499–526. https://doi.org/10.53519/analesranf.2024.90.04.06.
Full textSantana, Ricardo, Enrique Onieva, Robin Zuluaga, Aliuska Duardo-Sánchez, and Piedad Gañán. "The Role of Machine Learning in Centralized Authorization Process of Nanomedicines in European Union." Current Topics in Medicinal Chemistry 21, no. 9 (2021): 828–38. http://dx.doi.org/10.2174/1568026621666210319101847.
Full textVogel, Andreas M. "Hybrid or Mixed Marketing Authorization Application in the European Union: Not a Trivial Decision in New Development Programs for Established Drugs." Drug Information Journal 46, no. 4 (2012): 479–84. http://dx.doi.org/10.1177/0092861512443748.
Full textAnnur, Syarah Zahira, and Abdul Roup. "Tinjauan Atas Prosedur Pengajuan Hingga Pembayaran Klaim Asuransi Kendaraan Bermotor." Jurnal Aplikasi Bisnis Kesatuan 4, no. 3 (2024): 425–38. http://dx.doi.org/10.37641/jabkes.v4i3.1888.
Full textStawarska, Agnieszka, Magdalena Bamburowicz-Klimkowska, Elise Runden-Pran, et al. "Extracellular Vesicles as Next-Generation Diagnostics and Advanced Therapy Medicinal Products." International Journal of Molecular Sciences 25, no. 12 (2024): 6533. http://dx.doi.org/10.3390/ijms25126533.
Full textBurri, Padmaja* M. V. Nagabhushanam Brahmaiah Bonthagarala D. Nagarjuna Reddy G.Ramakrishna. "DOSSIER PREPARATION REQUIREMENTS FOR GENERIC DRUGS OF USA, EUROPE & INDIA." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 08 (2018): 7251–63. https://doi.org/10.5281/zenodo.1341324.
Full textBurri, Padmaja* M. V. Nagabhushanam Brahmaiah Bonthagarala D. Nagarjuna Reddy G.Ramakrishna. "DOSSIER PREPARATION REQUIREMENTS FOR GENERIC DRUGS OF USA, EUROPE & INDIA." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 08 (2018): 7251–63. https://doi.org/10.5281/zenodo.1341334.
Full textKapoor, Anjali, and Geeta Aggarwal. "Pre-filled syringes in developed and developing region: An insight into Regulatory considerations." International Journal of Drug Regulatory Affairs 7, no. 2 (2019): 42–50. http://dx.doi.org/10.22270/ijdra.v7i2.317.
Full textMadagoni, Krishna, Uppunuri Saidireddy, and Himaja . "A review on drug approval process in US, Europe and India-dossier, bioavailability and bioequivalence studies." INTERNATIONAL JOURNAL OF APPLIED PHARMACEUTICAL SCIENCES AND RESEARCH 1, no. 04 (2017): 133–46. http://dx.doi.org/10.21477/ijapsr.v1i4.6892.
Full textSmith, D., P. Trennery, D. Farningham, and J. Klapwijk. "The selection of marmoset monkeys (Callithrix jacchus) in pharmaceutical toxicology." Laboratory Animals 35, no. 2 (2001): 117–30. http://dx.doi.org/10.1258/0023677011911444.
Full textJ., Neelima K. Anie Vijetha A. Srivani P. Sravanthi. "REGULATORY DOSSIER- ASEAN COMMON TECHNICAL DOCUMENT (ACTD) FOR ASEM COUNTRIES." Indo American Journal of Pharmaceutical Sciences 04, no. 12 (2018): 4790–97. https://doi.org/10.5281/zenodo.1134382.
Full textAhammad, Nisar, Nagarjuna Reddy, M. V. Nagabhushanam, and Brahmaiah Ramakrishna. "Challenges Faced During eCTD and CTD Filling Procedures for USFDA and Canada." Journal of Drug Delivery and Therapeutics 9, no. 4-s (2019): 673–79. http://dx.doi.org/10.22270/jddt.v9i4-s.3334.
Full textMakwana, Rajdeep G., Kuldeep V. Desai, Vaibhav Kikani, and Maulikkumar D. Vaja. "Regulatory advances and prospects of variation filing for the registered parenteral products in USA and Europe." International Journal of Drug Regulatory Affairs 9, no. 2 (2021): 52–65. http://dx.doi.org/10.22270/ijdra.v9i2.470.
Full textJu, Jung Hun, Naery Lee, Sun-hee Kim, et al. "Points to consider for COVID-19 vaccine quality control and national lot release in Republic of Korea: focus on a viral vector platform." Osong Public Health and Research Perspectives 13, no. 1 (2022): 4–14. http://dx.doi.org/10.24171/j.phrp.2021.0311.
Full textRendra, Erika, Eleonora Scaccia, and Karen Bieback. "Recent advances in understanding mesenchymal stromal cells." F1000Research 9 (February 27, 2020): 156. http://dx.doi.org/10.12688/f1000research.21862.1.
Full textCave, Emma. "EU Clinical Trials Regulation 2014: Fetter or facilitator?" Medical Law International 18, no. 2-3 (2018): 179–94. http://dx.doi.org/10.1177/0968533218799535.
Full textWang, Valentine, Mélanie Gauthier, Véronique Decot, Loïc Reppel, and Danièle Bensoussan. "Systematic Review on CAR-T Cell Clinical Trials Up to 2022: Academic Center Input." Cancers 15, no. 4 (2023): 1003. http://dx.doi.org/10.3390/cancers15041003.
Full textSciberras, Josette, Raymond Zammit, and Patricia Vella Bonanno. "The European framework for intellectual property rights for biological medicines." Generics and Biosimilars Initiative Journal 10, no. 4 (2021): 172–83. http://dx.doi.org/10.5639/gabij.2021.1004.022.
Full textManita, Aakash Deep, Vikram, A. C. Rana, Monu Yadav, and Rakesh K. Marwaha. "Regulation of Medical Devices and their Clinical Trials Studies in the USA: An Update." Recent Innovations in Chemical Engineering (Formerly Recent Patents on Chemical Engineering) 13, no. 2 (2020): 94–109. http://dx.doi.org/10.2174/2405520412666190828202733.
Full textPooja Chaudhari and Jitendra Kumar Badjatya. "Good Practices in Management of deficiencies in CTD dossier and comparative study for US, EU and Australia." International Journal of Drug Regulatory Affairs 7, no. 4 (2019): 40–55. http://dx.doi.org/10.22270/ijdra.v7i4.371.
Full textBartling, Bastian, Johanna S. Rehfeld, Daniel Boßmann, et al. "Determination of the Structural Integrity and Stability of Polysialic Acid during Alkaline and Thermal Treatment." Molecules 25, no. 1 (2019): 165. http://dx.doi.org/10.3390/molecules25010165.
Full textGolocorbin-Kon, Svetlana, Ivana Ilickovic, and Momir Mikov. "Reasons for and frequency of off - label drug use." Medical review 68, no. 1-2 (2015): 35–40. http://dx.doi.org/10.2298/mpns1502035g.
Full textUmapathi, Uthanthi Thamizhselvi, Vijay Vijayakumar, Sivakumar Muthusamy, Vijayakumar Arumugam Ramamurthy, and Deepa Natarajan. "Regulatory requirement for Medical Devices." International Journal of Drug Regulatory Affairs 12, no. 1 (2024): 9–19. http://dx.doi.org/10.22270/ijdra.v12i1.636.
Full textDaousani, Chrysa, and Vangelis Karalis. "Paediatric Medicines: Regulatory and Scientific Issues." Drug Research 67, no. 07 (2017): 377–84. http://dx.doi.org/10.1055/s-0043-109788.
Full textGherghescu, Ioana, and M. Begoña Delgado-Charro. "The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA." Pharmaceutics 13, no. 1 (2020): 48. http://dx.doi.org/10.3390/pharmaceutics13010048.
Full textOgunbayo, Dapo, Diarmuid Coughlan, Ross Fairbairn, and Sola Akinbolade. "OP55 Classification System For Innovative Medicines In The Pipeline: New Or Repurposed?" International Journal of Technology Assessment in Health Care 38, S1 (2022): S21—S22. http://dx.doi.org/10.1017/s0266462322001088.
Full textStorm, Neal E., Wen Chang, Tzu-Chieh Lin, et al. "A Novel Case Study of the Use of Real-World Evidence to Support the Registration of an Osteoporosis Product in China." Therapeutic Innovation & Regulatory Science 56, no. 1 (2021): 137–44. http://dx.doi.org/10.1007/s43441-021-00342-4.
Full textHuber, Cynthia, Tim Friede, Julia Stingl, and Norbert Benda. "Classification of Companion Diagnostics: A New Framework for Biomarker-Driven Patient Selection." Therapeutic Innovation & Regulatory Science 56, no. 2 (2021): 244–54. http://dx.doi.org/10.1007/s43441-021-00352-2.
Full textKrendyukov, Andriy. "Explorative analysis of expanded access for intermediate-size and larger patient populations." Journal of Clinical Oncology 38, no. 15_suppl (2020): e19070-e19070. http://dx.doi.org/10.1200/jco.2020.38.15_suppl.e19070.
Full textMandasari, Ully. "Criminal Law Policy Sales of Illegal Cosmetic Products Online by the Central Food and Drug Administration (BPOM) in Pekanbaru City." Melayunesia Law 4, no. 2 (2020): 158. http://dx.doi.org/10.30652/ml.v4i2.7769.
Full textMurray, Donna Morgan, Susan M. Dansereau, Donna R. Park, Judith A. Reilman, and Barbara R. Snyder. "One Module to Many Submissions: Generating Global Marketing Authorization Applications." Drug Information Journal 34, no. 3 (2000): 779–92. http://dx.doi.org/10.1177/009286150003400314.
Full text