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Journal articles on the topic 'Drug Master File'

Author: Grafiati

Published: 4 June 2025

Last updated: 1 August 2025

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1

Suthar, Unnati, Zuki Patel, Vinit Movaliya, Niranajan Kanaki, Shrikalp Deshpande, and Maitreyi Zaveri. "Similarities and differences in filing for Drug Master File in US, Canada and Europe." International Journal of Drug Regulatory Affairs 11, no. 3 (2023): 33–38. http://dx.doi.org/10.22270/ijdra.v11i3.613.

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Drug Master File or DMF is a document prepared by a pharmaceutical manufacturer and submitted solely at its discretion to the applicable authority in the intended drug market. The document provides the non-supervisory authority with confidential, detailed information about installations, processes, or papers used in the manufacturing, processing, packaging, and storing of one or further mortal drugs. The DMF form allows an establishment to cover its intellectual property from its mate while complying with non-supervisory conditions for exposure of processing details. There is no non-supervisor

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Mange, Ram* Vipin Kukkar. "A Review On Drug Master File." International Journal in Pharmaceutical Sciences 2, no. 10 (2024): 806–11. https://doi.org/10.5281/zenodo.13936077.

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Master file on drugs A "DMF" is a document that includes details about the procedures, facilities, or materials used in the manufacturing, processing, packing, and storage of one or more human pharmaceuticals. A DMF contains information about the chemistry, manufacturing, and control of a drug component. A DMF is filed when two or more companies work together to develop or produce a medicinal product. Businesses can protect their partner's intellectual property by completing a DMF and following the regulatory requirements for processing information disclosure. Details about a drug formulation'

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Vijay, Kumar 1. *. Meenu Bist 2. Shashank 3. "NEW ADVANCEMENTS IN DRUG MASTER FILES GUIDELINES." Journal of Pharma Research 7, no. 11 (2018): 250–52. https://doi.org/10.5281/zenodo.1579716.

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<strong><em>ABSTRACT</em></strong> <strong><em>A</em></strong><em> Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. There are five types of DMFs, the most common being a Type II DMF followed by a Type III DMF. It should be noted, however, that only four DMFs (types II-V) are still actively submitted as the Type I DMF has been phased out. The Drug Master File filing allows

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Ashok kumar P, Nikhil HV, Rohith B, Venu T, Vinutha HG, and Sandeep KV. "Regulatory requirement and filling procedure of drug master file in India under central drug standard control organization (CDSCO) in comparison with South Korea." World Journal of Advanced Research and Reviews 23, no. 3 (2024): 2960–68. http://dx.doi.org/10.30574/wjarr.2024.23.3.2940.

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The Drug master file (DMF) is a type of Confidential file that submitted to regulatory authorities about the ingredients, process, packing and storage of any drugs intended to human use. Drug master file plays an important role in production of drug. The Indian regulatory agency is a CDSCO that manages and encourage DMFs in India and in South Korea MFDS manages the DMFs. Unveiling the difference in regulatory requirements and filling procedure of DMF in India and South Korea as per CDSCO and MFDS respectively. Make certain the Protection, Grade, and Effectiveness of Drug Products.

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Ashok, kumar P., HV Nikhil, B. Rohith, T. Venu, HG Vinutha, and KV Sandeep. "Regulatory requirement and filling procedure of drug master file in India under central drug standard control organization (CDSCO) in comparison with South Korea." World Journal of Advanced Research and Reviews 23, no. 3 (2024): 2960–68. https://doi.org/10.5281/zenodo.14982442.

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The Drug master file (DMF) is a type of Confidential file that submitted to regulatory authorities about the ingredients, process, packing and storage of any drugs intended to human use. Drug master file plays an important role in production of drug. The Indian regulatory agency is a CDSCO that manages and encourage DMFs in India and in South Korea MFDS manages the DMFs. Unveiling the difference in regulatory requirements and filling procedure of DMF in India and South Korea as per CDSCO and MFDS respectively. Make certain the Protection, Grade, and Effectiveness of Drug Products.

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Chokshi, Nirav. "The Japanese drug master file." Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector 8, no. 4 (2011): 219–26. http://dx.doi.org/10.1177/1741134311428567.

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Battaglino, Giuseppe. "The European Drug Master File." Drug Information Journal 27, no. 4 (1993): 1261–65. http://dx.doi.org/10.1177/009286159302700446.

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(Dr.) Mohd. Wasiullah, (Dr ). Mohd Wasiullah, (Dr ). Piyush Yadav .(Dr.) Piyush Yadav, Prof Sushil Yadav Prof Sushil Yadav, and Yadav Rahulkumar Ramchandra Yadav Rahulkumar Ramchandra. "Drug Master file in Emerging Market: Challenges and Opportunities." International Journal of Pharmaceutical Research and Applications 10, no. 2 (2025): 2054–60. https://doi.org/10.35629/4494-100220542060.

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A Drug Master File (DMF) is a confidential document submitted to regulatory authorities, detailing facilities, processes, and materials used in pharmaceutical production. Established to protect proprietary information while ensuring regulatory compliance, DMF systems have evolved globally, with harmonization efforts enhancing standardization and safeguarding pharmaceutical quality, safety, and efficacy. The Drug Master File (DMF) has gained global importance as pharmaceutical companies expand internationally. While the FDA oversees DMFs in the U.S., regions like the EU, Japan, and India have a

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Sravanti, Veera Kota Lakshmi, Ruchitha Bandla, and Ravi Kumar Reddy Juturi. "Filing of DMF in the US, EU, and India, and its comparative review." International Journal of Drug Regulatory Affairs 9, no. 1 (2021): 22–32. http://dx.doi.org/10.22270/ijdra.v9i1.453.

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A Drug Master File (DMF) covers all comprehensive, accurate, and precise information about Active Pharmaceutical Ingredient (API) or Finished Product Dosage Form (FP). It is a confidential document that contains complete, factual, and correct information about the active pharmaceutical ingredient and drug product's chemistry, manufacture, stability, purity, impurity profile, packaging, and the cGMP (Current Good Manufacturing Practices) status of any human drug product. When a DMF is filed, it allows a company to safeguard its intellectual property from its partner while complying with regulat

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Danej, Meghna, Ronak Dedania, Sanket Gandhi, Juhi Randeria, and Kankrej Gaurav. "Regulatory requirements for Drug master file in context to Canada and Australia." International Journal of Drug Regulatory Affairs 6, no. 2 (2018): 41–47. http://dx.doi.org/10.22270/ijdra.v6i2.236.

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Drug Master Files are required in most countries as supporting documents for the registration of drug products. DMFs generally contain information pertaining to the chemistry, manufacturing and controls (CMC) sections of the drug submission and reflect the drug’s identity, strength, purity and quality. Canada and Australia which are consider as highly regulated markets (HRMs). In CANADA, DMF filing was done through New Drug Submission (NDS) for both drugs and biologic products. They use MF terminology for DMF which contain four types of MASTER FILE- ASMFs, CCS MFs, Excipient MFs, Drug product

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Schwartz, Paul. "Drug master file review issues at the Office of Generic Drugs." Journal of Generic Medicines 3, no. 4 (2006): 280–86. http://dx.doi.org/10.1057/palgrave.jgm.4940130.

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Goloenko, N. G., R. I. Yagudina, A. Yu Kulikov, V. G. Serpik, M. V. Protsenko, and D. G. Karapetyan. "Results of a Sociological Survey on the Needs of Drug Safety Monitoring Specialists for Information on the Creation of the Pharmacovigilance System Master File." Safety and Risk of Pharmacotherapy 8, no. 2 (2020): 84–89. http://dx.doi.org/10.30895/2312-7821-2020-8-2-84-89.

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The Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union oblige developers and marketing authorisation holders to implement a pharmacovigilance system that has to be described in the pharmacovigilance system master file (PSMF). Analysis of public sources revealed lack of data describing the creation of a PSMF. Therefore, the creation of a PSMF and keeping it up to date may prove challenging for pharmacovigilance specialists.The aim of the study was to identify information needs of pharmacovigilance specialists by carrying out a sociological survey.Materials and methods: the

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Steimle, Sabine. "FDA Assigns Drug Master File to European Cancer Group." JNCI: Journal of the National Cancer Institute 90, no. 18 (1998): 1331. http://dx.doi.org/10.1093/jnci/90.18.1331.

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Pathak, Rahul, Rajat Singal, Sandip Mitra, Sanjay Koul, and Supriya Sharma. "Unlocking the benefits of Drug Master File filing in the Indian pharmaceutical industries." Indian Journal of Pharmacology 56, no. 5 (2024): 342–47. https://doi.org/10.4103/ijp.ijp_297_23.

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Abstract Ensuring the safety and quality of drugs is a crucial component for the development of any pharmaceutical industry. This requires stringent regulation in the process of drug manufacturing and marketing. A Drug Master File (DMF) serves as a comprehensive document containing information about the quality, safety, and manufacturing procedure/facility of a drug or drug substance. Many countries with highly regulated markets use the DMF system extensively to protect their intellectual property rights while providing accurate and detailed information about their products to regulatory bodie

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Gurram, Indu, M. V. S. Kavitha, Nagarjuna Reddy, and M. V. Nagabhushanam. "Drug Master File Filing in US, Europe, Canada and Australia." Journal of Pharmaceutical Research 16, no. 2 (2017): 160. http://dx.doi.org/10.18579/jpcrkc/2017/16/2/116432.

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Sun, I.-Chen, Fu-Chieh Lu, Ke-Jhen Lu, Tzu-Ya Liao, and Churn-Shiouh Gau. "Regulatory status of drug master file in Taiwan 2009–2011." Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector 11, no. 1-2 (2014): 56–63. http://dx.doi.org/10.1177/1741134314555879.

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Jenilkumar, J. Diyora*1 Vinit Movaliya2 Maitreyi Zaveri3. "A Comparative Study Of Drug Master File Regulation In Brazil, Malaysia And Russia." International Journal in Pharmaceutical Sciences 2, no. 6 (2024): 695–700. https://doi.org/10.5281/zenodo.11620058.

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The burgeoning pharmaceutical market in Brazil, Russia, and Malaysia presents a compelling opportunity for drug development and access. However, navigating the intricacies of drug registration in these countries requires a thorough understanding of their regulatory frameworks, including Drug Master File (DMF) filing procedures. This research article delves into a comparative analysis of DMF requirements in Brazil, Russia, and Malaysia, exploring similarities and differences in content requirements, submission procedures, and review processes. The aim is to equip pharmaceutical companies with t

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Agarwal, Pooja, and J. K. Badjatya. "DMF FILING IN US, EUROPE AND CANADA." International Journal of Drug Regulatory Affairs 3, no. 4 (2018): 9–17. http://dx.doi.org/10.22270/ijdra.v3i4.172.

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A Drug Master File or DMF is a reference source that provides drug evaluator’s confidential information not available to drug product manufacturer about the specific process and components used in the manufacturing, processing and packaging of a drug meant for Human/Animal use. The submission of a DMF is not required by law or FDA regulation. A DMF is submitted solely at the discretion of the holder. The information contained in the DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, or

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Sun, I.-Chen. "Advantages of using an abbreviated dossier for drug master file applications in Taiwan." Regulatory Toxicology and Pharmacology 80 (October 2016): 310–13. http://dx.doi.org/10.1016/j.yrtph.2016.05.034.

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Patel, Riya, Kunal R. Girase, Venkateshwara T. Rao, Amit A. Patel, and Ravish J. Patel. "Assessment of Regulatory requirements and filing procedure of Drug Master File for Brazil, Europe and South Africa." International Journal of Drug Regulatory Affairs 10, no. 2 (2022): 14–27. http://dx.doi.org/10.22270/ijdra.v10i2.517.

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A Drug Master File is a record that consists of detailed, correct data approximately an Active Pharmaceutical Ingredient (API) or Dosage Form of a Finished Product (FP). It is a classified document containing thorough, accurate, and up-to-date information regarding the active medicinal ingredient and medicament. A DMF is divided into two sections: (a) Open part (the Applicant's Part), which includes all of the details needed to determine the quality of a product. And (b) the Closed Part (Restricted Part). The Restricted Part (Closed Part) comprises openly undisclosed manufacturing method knowl

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Sun, I.-Chen. "Application profile of full and abbreviated dossiers for drug master file: An experience of Taiwan." Journal of Medical Sciences 37, no. 3 (2017): 81. http://dx.doi.org/10.4103/jmedsci.jmedsci_111_16.

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Kola, Satish Shamrao, Vishnu Nayak Badavath, Mohammad Idrees M. Siddique, Naqui Siddiqui, Chandrashekhar Devkate, and Syed Abrar Ahmed. "Microwave-assisted green synthesis and molecular docking study of some new 4-thiazolidinone derivatives as possible bioactive agents." INDIAN JOURNAL OF HETEROCYCLIC CHEMISTRY 34, no. 03 (2024): 327. http://dx.doi.org/10.59467/ijhc.2024.34.327.

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We have developed an economical and environmentally friendly microwave-assisted efficient method for the synthesis of a series of new 4-oxo-thiazolidine derivatives (4a-d). The method involves microwave irradiated cyclocondensation reaction of Schiff bases (3a-d) and thioglycolic acid in drug master file (DMF). 4-oxo-thiazolidine derivatives (4a-d) was also synthe 4-Oxo-Thiazolidine derivatives were also synthesized by conventional heating procedures and consequence were Compared with Microwave assisted green method. The results suggest that microwave-assisted syntheses lead to higher yields w

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Reddy, Kunta N., and Surenahalli G. Vasantharaju. "Comparison of Regulatory Requirements for Filing Drug Master File (DMF) in Emerging Markets - China, Brazil & South Korea." Applied Clinical Research, Clinical Trials and Regulatory Affairs 7, no. 1 (2020): 71–81. http://dx.doi.org/10.2174/2213476x06666190916122404.

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Background: A DMF consists of confidential information, usually related to Chemistry, Manufacturing and Control (CMC) of the drug substance. DMF is prepared and submitted by the pharmaceutical manufacturer solely to the regulatory authority of the respected country where he wants to market. Objective: Compare the regulations of the emerging markets with that of a regulated market and to highlight the stringent requirements imposed by emerging authorities. The similarities and differences of the requirements for filing a DMF in emerging markets are compared against the regulated market. Methods

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Yadav, Saurabh, Subhranshu Panda, and Ankita Raikwar. "A Review Process of ANDA Filling in PMDA (Japan) and Calibration of UV in Accordance to its Regulatory Guidelines." International Journal of Pharma Professional’s Research (IJPPR) 14, no. 4 (2023): 113–27. http://dx.doi.org/10.48165/ijppronline.2023.14409.

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The Abbreviated New Drug Application (ANDA) filing system is an important regulatory process in Japan for the approval of generic drugs. This system allows pharmaceutical companies to submit an application for the marketing and sale of a generic drug, which has already been approved by the regulatory agency in another country. The ANDA system in Japan is similar to that of the United States and Europe, but there are some unique aspects that must be taken into account. For example, in Japan, the regulatory agency requires a separate drug master file for each active pharmaceutical ingredient, wh

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Howlett, Moninne, Michael Curtin, Dermot Doherty, Paula Gleeson, Michelle Sheerin, and Cormac Breatnach. "PAEDIATRIC STANDARDISED CONCENTRATION INFUSIONS – A NATIONAL SOLUTION." Archives of Disease in Childhood 101, no. 9 (2016): e2.71-e2. http://dx.doi.org/10.1136/archdischild-2016-311535.73.

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AimWide scale implementation of paediatric standardised concentration infusions (SCIs) and the use of smart pump technology has been slow despite international safety agency recommendations. Implementation rates in European hospitals fall far below those in the United States, where for the last decade accreditation has been linked to implementation.1 2 Multidisciplinary collaboration is essential, with pharmacy input and the creation of a smart pump drug library recognised as often being limiting, yet crucial factors, to implementation.3 Following on from the successful development and impleme

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Rataj, Alison, Matthew Alcusky, Brian Ott, Jonggyu Baek, Shiwei Liang, and Kate Lapane. "COVID-19 MORTALITY RATES AND CHANGES IN ANTI-DEMENTIA AND PSYCHOTROPIC MEDICATION USE AMONG NURSING HOME RESIDENTS." Innovation in Aging 8, Supplement_1 (2024): 877. https://doi.org/10.1093/geroni/igae098.2837.

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Abstract Objective. We examined the relationship between nursing home (NH) COVID-19 mortality rates and changes in antidementia and psychotropic medication initiation before and during the pandemic and explored the influence of staffing and resident factors. Methods. Changes in medication initiation were collected through a novel, nationally representative cross-sectional Dementia Treatment Survey (2022) of NH Directors of Nursing. Outcome measures were created by collapsing a 5-point Likert scale contrasting less/about the same vs. more initiation and less versus more/about the same initiatio

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Türei, Dénes, Diána Papp, Dávid Fazekas, et al. "NRF2-ome: An Integrated Web Resource to Discover Protein Interaction and Regulatory Networks of NRF2." Oxidative Medicine and Cellular Longevity 2013 (2013): 1–9. http://dx.doi.org/10.1155/2013/737591.

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NRF2 is the master transcriptional regulator of oxidative and xenobiotic stress responses. NRF2 has important roles in carcinogenesis, inflammation, and neurodegenerative diseases. We developed an online resource, NRF2-ome, to provide an integrated and systems-level database for NRF2. The database contains manually curated and predicted interactions of NRF2 as well as data from external interaction databases. We integrated NRF2 interactome with NRF2 target genes, NRF2 regulating TFs, and miRNAs. We connected NRF2-ome to signaling pathways to allow mapping upstream NRF2 regulatory components th

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Taylor, Kimberly L., Lynda Lanning, Lawrence Wolfraim, et al. "A U.S. Government-Coordinated Effort to Leverage Non-Human Primate Data to Facilitate Ebolavirus Vaccine Development." Vaccines 10, no. 8 (2022): 1201. http://dx.doi.org/10.3390/vaccines10081201.

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A United States Government (USG) interagency group, the Filovirus Animal Non-Clinical Group (FANG), has been established to support the development of biodefense medical countermeasures (MCMs). As both vaccines and therapeutics are licensed using “non-traditional pathways”, such as the U.S. Food and Drug Administration’s (FDA) Animal Rule (AR), non-human primate (NHP) models and associated assays have been developed and standardized across BSL4 testing sites to evaluate candidate products. Vaccine candidates are evaluated using these NHP models, and through this public–private partnership, a m

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Lollis, S. Scott, Pablo A. Valdes, Zhongze Li, Perry A. Ball, and David W. Roberts. "Cause-specific mortality among neurosurgeons." Journal of Neurosurgery 113, no. 3 (2010): 474–78. http://dx.doi.org/10.3171/2010.1.jns091740.

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Object The authors sought to determine a cause-specific mortality profile for US neurosurgeons during the period 1979–2005. Methods Neurosurgeons who died during the study period were identified from the Physician Master File database. Using the National Death Index, the reported cause of death was identified for 93.7% of decedents. Standardized mortality ratios were used to compare mortality risk in the study cohort to that of the US population. Results There was a marked reduction in mortality from virtually all causes in comparison with the control population. This finding is consistent wit

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Alexander, Bruce H., Harvey Checkoway, Sonia I. Nagahama, and Karen B. Domino. "Cause-specific Mortality Risks of Anesthesiologists." Anesthesiology 93, no. 4 (2000): 922–30. http://dx.doi.org/10.1097/00000542-200010000-00008.

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Background The health-related effects of the operating room environment are unclear. The authors compared mortality risks of anesthesiologists to those of internal medicine physicians between 1979 and 1995. Methods The Physician Master File database, a listing of all US physicians, was used to identify anesthesiologists and general internists. The cohort of internists (n = 40,211) was a stratified random sample of all internists, frequency-matched to the cohort of anesthesiologists (n = 40,242) by gender, decade of birth, and US citizenship. The National Death Index was used to confirm death s

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Snegireva, I. I., E. O. Zhuravleva, and N. Yu Velts. "Expert Evaluation of Pharmacovigilance System Documents Included in the Registration Dossier." Safety and Risk of Pharmacotherapy 8, no. 4 (2020): 191–97. http://dx.doi.org/10.30895/2312-7821-2020-8-4-191-197.

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The Russian Federation and the member states of the Eurasian Economic Union (EAEU) are working on the creation of a common pharmaceutical market. EAEU marketing authorisation may be granted to those pharmaceutical companies whose activities comply with the Good Pharmacovigilance Practice (GVP). The aim of the study was to analyse pharmacovigilance system documents submitted as part of registration dossiers of medicines and to identify problems that may arise during preparation of the pharmacovigilance system master file (PSMF). The authors analysed the PSMF, which makes part of the registratio

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Coffey, Robert J., Mary L. Owens, Steven K. Broste, et al. "Mortality Associated with Implantation and Management of Intrathecal Opioid Drug Infusion Systems to Treat Noncancer Pain." Anesthesiology 111, no. 4 (2009): 881–91. http://dx.doi.org/10.1097/aln.0b013e3181b64ab8.

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Background In 2006, the authors observed a cluster of three deaths, which circumstances suggested were opioid-related, within 1 day after placement of intrathecal opioid pumps for noncancer pain. Further investigation suggested that mortality among such patients was higher than previously appreciated. The authors performed investigations to quantify that mortality and compare the results to control populations, including spinal cord stimulation and low back surgery. Methods After analyzing nine index cases--three sentinel cases and six identified by a prospective strategy--the authors used epi

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黃振彰, 黃振彰, 顏妙如顏妙如, 陳旭輝陳旭輝, 沈玫秋沈玫秋 та 楊璦瑜楊璦瑜. "建置小兒用藥極量檢核提升用藥安全專案". 醫療品質雜誌 18, № 1 (2024): 040–48. http://dx.doi.org/10.53106/199457952024011801006.

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<p>目的：小兒族群的藥品劑量主要以mg/kg計算，然而目前病人端缺乏完整體重資訊、警示系統未區分小兒與成人、藥品檔缺乏小兒極量資料。方法：運用品管圈問題解決型找出三項真因：劑量檢核邏輯不適用於小兒族群、未強制輸入身高體重、藥品主檔缺乏小兒極量設定，進而擬定對策。結果：小兒劑量過高的異常件數，改善前為2件，目標降至0件，改善後為1件。再介入：主因劑量計算後有時會微調成整數可能略高極量，因此現行警示訊息皆為提示。與臨床科共識，增設極量的1.1倍設為阻擋，追蹤至2023年7月未再有異常件數。結論：本次專案改善後成效良好推廣至體系醫院，共同提升小兒用藥安全，然而藥品品項繁多，尚需持續進行資料建檔以提供更全面的把關。</p> <p>&nbsp;</p><p>Objective: Pediatric dosages are primarily mg/kg-based. However, currently, patient records lack complete weight information, the alert system does not differentiate between pediatric and adult patients, and the drug database lacks pedia

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McCafferty, Kieran, Zoe Hollowood, Michelle Allan, Donna Lockhart, Jamie Chorlton, and John Martin. "ARCADIA study protocol: a phase II, randomised, double-blind, placebo-controlled clinical trial to assess the safety and efficacy of AZD1656 in patients with diabetes hospitalised with suspected or confirmed COVID-19." BMJ Open 11, no. 12 (2021): e049650. http://dx.doi.org/10.1136/bmjopen-2021-049650.

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IntroductionCOVID-19, caused by SARS-CoV-2, remains a global pandemic that has affected more than 100 million people worldwide with over 4.8 million deaths as of October 2021. Patients with diabetes have both an increased susceptibility to SARS-CoV-2 infection, enhanced disease severity and increased risk of mortality. The challenge presented in these patients is both to improve glycaemic control—which itself may confer a survival advantage—and to help maintain or restore immunological homeostasis. The specific glucokinase activator AZD1656 may address both of these challenges via its glucose-

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Chism, David D., Biren Saraiya, Tanya B. Dorff, et al. "HB-300, a novel arenavirus-based cancer immunotherapy in patients with metastatic castration-resistant prostate cancer." Journal of Clinical Oncology 41, no. 16_suppl (2023): TPS5108. http://dx.doi.org/10.1200/jco.2023.41.16_suppl.tps5108.

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TPS5108 Background: Prostate cancer is the most frequent type of malignant neoplasia in men. Immunotherapy targeting self-antigens in prostate cancer is evolving and requires overcoming multiple mechanisms that mediate immune tolerance. Sipuleucel-T, a cell-based therapy recognizing prostatic acid phosphatase (PAP) protein, is approved for treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) and induced PAP-specific T cell responses correlating with overall survival (OS). Poxvirus vectors encoding prostate-specific antigen (PSA) increased PSA-specific T cell level

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Matsuhama, Maki, Tomoko Takishita, Ryosuke Kuribayashi, Kazunori Takagi, Rika Wakao, and Kenichi Mikami. "Similarities and Differences of International Practices and Procedures for the Regulation for Active Substance Master Files/Drug Master Files of Human Use: Moving Toward Regulatory Convergence." Journal of Pharmacy & Pharmaceutical Sciences 19, no. 2 (2016): 290–300. http://dx.doi.org/10.18433/jpps.v19i2.27066.

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Purpose. A gap analysis survey of international practices for Active Substance Master Files (ASMFs)/Drug Master Files (DMFs) of human use was conducted as a project of the ASMF/DMF working group of the International Generic Drug Regulators Pilot (IGDRP) to identify similarities and differences among ASMF/DMF procedures of 10 IGDRP members and 2 observers. Methods. We conducted a questionnaire survey and compared the following aspects: overall ASMF/DMF procedures, submission requirements for ASMFs/DMFs, assessment processes for ASMFs/DMFs, the technical requirements for active pharmaceutical in

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Matsuhama, Maki, Tomoko Takishita, Ryosuke Kuribayashi, Kazunori Takagi, Rika Wakao, and Kenichi Mikami. "Similarities and Differences of International Practices and Procedures for the Regulation for Active Substance Master Files/Drug Master Files of Human Use: Moving Toward Regulatory Convergence." Journal of Pharmacy & Pharmaceutical Sciences 19, no. 2 (2016): 290. http://dx.doi.org/10.18433/j37g80.

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Purpose. A gap analysis survey of international practices for Active Substance Master Files (ASMFs)/Drug Master Files (DMFs) of human use was conducted as a project of the ASMF/DMF working group of the International Generic Drug Regulators Pilot (IGDRP) to identify similarities and differences among ASMF/DMF procedures of 10 IGDRP members and 2 observers. Methods. We conducted a questionnaire survey and compared the following aspects: overall ASMF/DMF procedures, submission requirements for ASMFs/DMFs, assessment processes for ASMFs/DMFs, the technical requirements for active pharmaceutical in

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Kumar, Jena Deepak, Vishwajeet Mohan, Padmanabhuni Venkata Appaji, Lanka Srinivas, and Poduri Balaram. "Presence of Indian Pharmaceutical Industries in US Market: An Empirical Analysis." Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector 6, no. 4 (2009): 333–44. http://dx.doi.org/10.1057/jgm.2009.27.

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The United States is the largest pharmaceutical market in the world with generic sales accounting for US$58.5 billion and is India's largest export destination. India accounts for one out of every four Abbreviated New Drug Application (ANDA) approvals in the years 2007 and 2008, ranks first in total Type II active Drug Master Files (DMFs) with US Food and Drug Administration and it also received 31 per cent of all tentative approvals (as on 11 December 2008). In 2008, the exports of formulations from India to top 28 regulated countries surpassed Active Pharmaceutical Ingredient (API) exports f

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Brown, Andrew J. "Isoprenoid is a perfect fit for fat factor." Biochemical Journal 438, no. 1 (2011): e1-e3. http://dx.doi.org/10.1042/bj20110996.

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In humans, there are 48 members of the superfamily of nuclear receptors. These ligand-activated transcription factors help to integrate our growth, reproduction and metabolism via environmental, nutritional and intrinsic cues. It is therefore not surprising that nuclear receptors are commonly used as drug targets. However, perhaps in the rush to discover new drugs that target these receptors, we sometimes lose sight of their ‘real’ physiological ligands. In this issue of the Biochemical Journal Goto et al. present evidence that the isoprenoid FPP (farnesyl pyrophosphate) may be a bona fide lig

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Fonseca, Rafael, Safiya Abouzaid, Machaon Bonafede, et al. "Real-World Trends in Treatment Use, Healthcare Costs, and Overall Survival Among Patients with Multiple Myeloma." Blood 128, no. 22 (2016): 3558. http://dx.doi.org/10.1182/blood.v128.22.3558.3558.

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Abstract Introduction: There have been substantial advances in treatment options for multiple myeloma (MM) over the past 15 years, yet little real-world evidence is available to describe the recent trends in MM treatment costs and outcomes. This study aimed to examine the trends in novel therapy use, total healthcare costs, and survival outcomes among newly diagnosed MM patients in the US since 2000. Methods: Patients aged ≥18 years who had ≥ 2 medical claims with MM (ICD-9 diagnosis code 203.0x) at least 30 days apart between January 2000 and September 2015 were identified in the Truven Healt

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Matsuhama, Maki, and Ryosuke Kuribayashi. "Analysis of Drug Master Files registered in Japan: aiming for a stable supply of active pharmaceutical ingredients." Generics and Biosimilars Initiative Journal 7, no. 1 (2018): 8–13. http://dx.doi.org/10.5639/gabij.2018.0701.003.

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Zhang, Huyi, Haitao Li, Wei Song, et al. "Completeness Assessment of Type II Active Pharmaceutical Ingredient Drug Master Files under Generic Drug User Fee Amendment: Review Metrics and Common Incomplete Items." AAPS Journal 16, no. 5 (2014): 1132–41. http://dx.doi.org/10.1208/s12248-014-9630-7.

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Sutton, Sharon, Eimear McGrath, Cormac Breatnach, and Moninne Howlett. "P31 Optimisation of smart-pump drug library functionality – supporting national standardisation." Archives of Disease in Childhood 107, no. 5 (2022): e25.32-e25. http://dx.doi.org/10.1136/archdischild-2022-nppg.38.

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AimTo optimise smart-pump functionality as part of an ongoing multi-phase project to develop a national smart-pump drug library of standard concentration infusions (SCIs) suitable for paediatric and neonatal patients in paediatric, maternity and adult hospitals.MethodMultidisciplinary working groups with representation from paediatric, neonatal and adult intensive care units (ICUs) were established. Agreed lists of SCIs for separate neonatal and paediatric drug libraries were developed. A paediatric SCI drug library, originally developed by the lead site in 2012 containing 42 drug lines (prima

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Ortega Diego, Isabel, Antony Fake, Matthias Stahl, and Lembit Rägo. "Review of Quality Deficiencies Found in Active Pharmaceutical Ingredient Master Files Submitted to the WHO Prequalification of Medicines Programme." Journal of Pharmacy & Pharmaceutical Sciences 17, no. 2 (2014): 169. http://dx.doi.org/10.18433/j3q60j.

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Purpose. The aim of this work was to determine the number and type of active pharmaceutical ingredient (API) quality deficiencies in API Master Files (APIMFs) as submitted to the World Health Organization (WHO) Prequalification of Medicines Programme (PQP). Methods. We conducted a retrospective review of API quality deficiencies identified following the assessment of new APIMFs for non-sterile APIs during a 6-year period from 1 January 2007 to 31 December 2012. All deficiencies were collected, classified and quantified according to the Common Technical Document (CTD) sections and subsections a

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An, Young-Hyeon, and Su-Hwan Kim. "Facile Fabrication of Three-Dimensional Hydrogel Film with Complex Tissue Morphology." Bioengineering 8, no. 11 (2021): 164. http://dx.doi.org/10.3390/bioengineering8110164.

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In this study, we proposed a simple and easy method for fabricating a three-dimensional (3D) structure that can recapitulate the morphology of a tissue surface and deliver biological molecules into complex-shaped target tissues. To fabricate the 3D hydrogel film structure, we utilized a direct tissue casting method that can recapitulate tissue structure in micro-/macroscale using polydimethylsiloxane (PDMS). A replica 3D negative mold was manufactured by a polyurethane acrylate (PUA)-based master mold. Then, we poured the catechol-conjugated alginate (ALG-C) solution into the mold and evaporat

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Zhang, Li, Yuan Ren, and Jianmei Hao. "Mechanism of Action of Taohong Huazhuo Decoction the Empirical Prescription Made by Professor Yang Zhen of Master of Traditional Chinese Medicine in Treating Hepatic Fibrosis based on Network Pharmacology and Molecular Docking Techniques." Journal of Contemporary Medical Practice 6, no. 8 (2024): 46–52. http://dx.doi.org/10.53469/jcmp.2024.06(08).10.

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Objective: To explore the mechanism of Taohong Huazhuo Decoction, the empirical prescription made by professor Yang Zhen of master of traditional Chinese medicine(TCM) in the treatment of hepatic fibrosis based on network pharmacology and molecular docking technology. Methods: The active ingredients and their corresponding effective targets of Taohong Huazhuo Decoction were screened using the TCM pharmacology database and analysis platform; the potential targets of hepatic fibrosis were obtained from GeneCards database and OMIM database, and then were processed to obtain common potential targe

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Bailey, Thomas C., and Richard M. Reichley. "Investigation of a Computer Virus Outbreak in the Pharmacy of a Tertiary Care Teaching Hospital." Infection Control & Hospital Epidemiology 13, no. 10 (1992): 594–98. http://dx.doi.org/10.1086/646434.

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AbstractObjective:A computer virus outbreak was recognized, verified, defined, investigated, and controlled using an infection control approach. The pathogenesis and epidemiology of computer virus infection are reviewed.Design:Case-control study.Setting:Pharmacy of a tertiary care teaching institution.Results:On October 28, 1991, 2 personal computers in the drug information center manifested symptoms consistent with the “Jerusalem” virus infection. The same day, a departmental personal computer began playing ‘Yankee Doodle,” a sign of “Doodle” virus infection. An investigation of all departmen

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Feltkamp, H. "Drug Master Files, Global Harmonization of Quality Standards, Hrsg. H. Möller und W. H. Oeser, Paperback APV, Bd. 30, Wissenschaftliche Verlagsgesellschaft mbh Stuttgart 1992, Kart., DM 89,-." Pharmazie in Unserer Zeit 22, no. 4 (1993): 198–99. http://dx.doi.org/10.1002/pauz.19930220417.

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Ghosh, Shrestha, Mahesh Raundhal, Samuel A. Myers, et al. "Atypical Kinase RIOK2 Is a Master Regulator of Hematopoietic Cell Fate." Blood 138, Supplement 1 (2021): 300. http://dx.doi.org/10.1182/blood-2021-149779.

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Abstract Here we report the discovery of a new master regulator of cell fate during hematopoietic differentiation, one whose function has major implications for the treatment of blood disorders such as anemia. Anemia is a major comorbidity in aging, chronic diseases such as renal failure and inflammation, bone marrow failure disorders and in hematologic neoplasms such as myelodysplastic syndromes (MDS), affecting roughly one third of the world population. Anemia is also often diagnosed in patients treated with chemotherapy or other cytotoxic agents. The comorbidities of peripheral blood cytope

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Sharma, Anil Kumar, Nitin M. Nagarkar, Charandeep Singh Gandhoke, et al. "Rhinocerebral mucormycosis (RCM): To study the clinical spectrum and outcome of 61 cases of RCM managed at a tertiary care center in India." Surgical Neurology International 14 (January 20, 2023): 15. http://dx.doi.org/10.25259/sni_1065_2022.

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Background: Mucormycosis is a life-threatening infection of the paranasal sinuses and nasal cavities that can easily spread to the orbit and the brain. It is caused by fungi of the family Mucoraceae. We present a case series of 61 patients diagnosed and treated for rhinocerebral mucormycosis (RCM) at a single tertiary health care center. Methods: After obtaining ethical clearance, all patient files with a final diagnosis of RCM were thoroughly analyzed in departmental records and a master chart was prepared. The study evaluated the etiology, clinical spectrum, diagnosis, management, complicati

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