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Development of a Highly Sensitive Method for Quantitative Estimation of Dimethyl Sulfate Impurity in Neostigmine Methylsulfate Drug substances by Using GC-MS
Free accessBASE | 2019|Sulfate (DMS) impurity in Neostigmine Methylsulfate drug substance. The method was validated as per International Council for Harmonisation (ICH ... -
Review of From Alzheimer’s to Zebrafish: Eclectic Science and Regulatory Stories
Online Contents | 2012|Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
The Food and Drug Administration and the International Conference on Harmonization: How Harmonious Will International Pharmaceutical Regulations Become?
British Library Conference Proceedings | 1995|Publisher: Washington College of Law -
Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics
Free accessDOAJ | 2015|Very recently, Food and Drug Administration (FDA) has approved a few new drug applications (NDA) with regulatory flexibility for quality by ... -
The Role of Regulatory T Cells in Cancer Treatment Resistance
Free accessDOAJ | 2023|patients. One of the main causes is regulatory T lymphocytes (Tregs), which suppress excessive inflammatory responses via the secretion of ...Keywords: regulatory T cell -
A Patient Centricity Team Tool to Enable Patient-Focused Drug Development
Online Contents | 2016|Abstract In order to better understand and advance the field of patient-focused drug development, a multifunctional patient affairs team ...Publisher: Springer International Publishing, Springer Nature, [New York]Keywords: patient-focused drug development -
A Regulatory Perspective on Validation of Surrogate Endpoints
Online Contents | 2007|the critical path of drug development. During the 41st DIA Annual Meeting in Washington, DC, Dr. Lawrence Lesko from the Office of Clinical ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Current Perspective Regarding the Immunopathogenesis of Drug-Induced Hypersensitivity Syndrome/Drug Reaction with Eosinophilia and Systemic Symptoms (DIHS/DRESS)
Free accessDOAJ | 2021|Drug-induced hypersensitivity syndrome/drug reaction with eosinophilia and systemic symptoms (DIHS/DRESS) is a severe type of adverse drug ...Keywords: drug-induced hypersensitivity syndrome, drug reaction with eosinophilia and systemic symptoms -
The European agency and the current regulatory scenario
British Library Conference Proceedings | 1994|Keywords: drug development -
General Interest - Role of the U.S. Food and Drug Administration in the Regulatory Management of Human Listeriosis in the United States
Online Contents | 2008|Publisher: International Association for Food Protection, Des Moines, Iowa -
Xyloglucan: A functional biomacromolecule for drug delivery applications
Elsevier | 2017|obtained from Tamarind seeds or kernel.The important properties of xyloglucan include ...Keywords: Drug delivery -
Complex Drugs and Biologics: Scientific and Regulatory Challenges for Follow-on Products
Online Contents | 2012|Abstract Since the passage of the Health Care Reform Act, the Food and Drug Administration has been working to develop consistent ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
An Integrated Bioinformatics and Quantitative Modeling Approach to Investigate Potential Claims of Oral Generic Drug Product Bioinequivalence: Introduction
Wiley | 2019|Keywords: Regulatory/Scientific Affairs (REG) -
Development and Application of Scorecards to Assess the Quality of a Regulatory Submission and Its Review
Online Contents | 2012|dossier to the ultimate regulatory decision. Two scorecards were developed through a process of conceptualization, item generation, and reduction ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif.Keywords: regulatory authority, quality of submission, quality of review -
Regulatory divergences: a barrier to trade and a potential source of trade disputes
Taylor & Francis Verlag | 2011| -
Emerging Role of miRNAs in the Drug Resistance of Gastric Cancer
Free accessDOAJ | 2016|advanced, non-curable stage and with a limited response to chemotherapy. Drug resistance is one of the most important causes of therapy failure in ...Keywords: drug resistance -
On the drivers of drug shortages: empirical evidence from Germany
Emerald Group Publishing | 2023|characteristics, (2) drug substance characteristics and (3) regulatory characteristics on the likelihood of a shortage ...Keywords: Drug substance, Drug shortage, Regulatory characteristics -
mRNA: Vaccine or Gene Therapy? The Safety Regulatory Issues
Free accessDOAJ | 2023|at the time they were marketed. The regulatory agencies therefore adapted them as a matter of urgency. Now that the pandemic emergency has ...Keywords: drug regulation -
Dynamical modeling of drug effect using hybrid systems
Free accessSpringer Verlag | 2012|article provides systematic mathematical analysis and dynamical modeling of drug effect under gene regulatory network contexts. A hybrid systems ...Publisher: Springer International Publishing, ChamKeywords: Drug effect, Gene regulatory network (GRN) -
7th Middle East Regulatory Conference (MERC)
Online Contents | 2007|Abstract The 7th Middle East Regulatory Conference (MERC), hosted by the Ministry of Health, the United Arab Emirates, took place in Dubai ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif.
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