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Careers in Regulatory Affairs
Wiley | 2010|such as pharmaceutical regulatory affairs (RA). RA operates at the interface of science, law, and business, applying scientific rationale along ...Publisher: Federation of American Societies for Experimental Biology -
Regulatory Affairs: Master of Science at San Diego State University
Wiley | 2010|regulations and policies; Interpret FDA‐related laws and regulations; Identify responsibilities of the regulatory affairs professional that extend ...Publisher: Federation of American Societies for Experimental Biology -
Overview on Nitrogen containing compounds and their assessment based on ‘International Regulatory Standards’
Free accessBASE | 2018|various aspects of heterocyclic compounds with its biological activity & regulatory assessment based on the ‘International Regulatory Standards ...Publisher: Vinita Nagar, Society of Pharmaceutical Technocrats, 1/7756, Street no. 1, East Gorakh Park, Shahdara, Delhi, India 110032, Journal of Drug Delivery and Therapeutics (JDDT) -
International course: Clinical drug development—Scientific and regulatory strategies
National licenceLeiden, January 21–22, 1982Elsevier | 1981 -
Chitosan-based microneedles as a potential platform for drug delivery through the skin: Trends and regulatory aspects
Elsevier | 2021|significant interest due to its ability of film-forming, biodegradability, and biocompatibility, making it suitable for topical and transdermal drug ...Keywords: Regulatory aspects -
Medical Affairs
Wiley | 2010|Keywords: Medical Affairs, Consolidated Standards of Reporting Trials (CONSORT), New Drug Application (NDA), International Committee of Medical Journal Editors (ICMJE) -
Regulatory Concerns at Various Phases of Drug Development
British Library Conference Proceedings | 1998| -
Regulatory and Quality Aspects of Herbal Drugs
Bentham Science Publishers | 2017|interaction, side effects, toxicity and adverse effects. The International Drug Monitoring Program of World Health Organization (WHO) has made certain ...Keywords: regulatory authority, drug interactions., Clinical Trials&Regulatory Affairs -
Quality specifications for peptide drugs: a regulatory‐pharmaceutical approach
Wiley | 2009|(i.e. quality attributes, procedures and acceptance criteria) as part of their quality assurance to ensure the safety and efficacy of drug ...Keywords: regulatory affairs, peptide drug substance -
Antibody-Drug Conjugates: The New Frontier of Chemotherapy
Free accessDOAJ | 2020|In recent years, antibody-drug conjugates (ADCs) have become promising antitumor agents to be used as one of the tools in personalized ...Keywords: Antibody-Drug Conjugate, drug targeting -
Pharmacogenetics of Drug-Resistant Epilepsy (Review of Literature)
Free accessDOAJ | 2021|drug resistance, different response to the drug, the possibility of using reliable methods to assess the control of seizures and side effects ...Keywords: drug-resistant epilepsy -
Editorial of Special Issue “Regulatory Roles of Inflammasomes in Human Diseases”
Free accessDOAJ | 2021|step) and triggering (activation step). The key feature of the triggering step is the activation of inflammasomes that are intracellular ... -
Aspect of adhesives in transdermal drug delivery systems
Tema Archive | 2014|effective amount of drug across the skin. The quality attribute of the adhesives in TDDS is indispensible for fabrication design and important to ... -
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 -
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 ... -
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 -
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 -
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 -
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 ...
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