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Comparison and Analysis of the National Drug Code Systems Among Drug Information Databases
Online Contents | 1998|} $, First $ DataBank^{®} $, Bergen Brunswig-Durr $ Fillauer^{®} $, and the Department of Veteran Affairs pharmaceutical information systems. A large ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Regulatory Strategies for the Development of Adjunctive Cancer Chemotherapies
Online Contents | 1997|Abstract A key to obtaining timely approval of a new drug application for an adjunctive chemotherapy for cancer is the early development of ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
French Specific Surveillance System for Drug Abuse
Taylor & Francis Verlag | 2014|regulatory measures. OPPIDUM’s experience clearly demonstrates that collection of valid and useful data on drug abuse is possible. This post ... -
The regulatory approvals of immune checkpoint inhibitors in China and the United States: A cross‐national comparison study
Wiley | 2023|the drug labels and reviewing documents disclosed on the official websites of the US Food and Drug Administration (FDA) and the Center for ...Keywords: regulatory approval -
Recent Use of Pediatric Extrapolation in Pediatric Drug Development in US
Taylor & Francis Verlag | 2023|The regulatory standards of the United States Food and Drug Administration (FDA) require substantial
... -
NSCLC harboring EGFR exon‐20 insertions after the regulatory C‐helix of kinase domain responds poorly to known EGFR inhibitors
Wiley | 2016|) with a nine‐base insertion at 2316 (P772‐H773insDNP). Both insertions immediately follow the regulatory C‐helix of the kinase domain. Contrary ... -
The New Attitude of the European Regulatory Authorities About Herbal Medicinal Products
Online Contents | 2000|order to provide guidance for applicants and prepare recommendations on the criteria for the assessment of quality, safety, and efficacy of ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Quality assessment of cold chain storage facilities for regulatory and quality management compliance in a developing country context
Wiley | 2022|address drug distribution do not adequately address the issue of cold chain management in addition to challenges in implementation. Given the ...Keywords: regulatory compliance -
Germline variation in TP53 regulatory network genes associates with breast cancer survival and treatment outcome
Wiley | 2013|previously suggested to have an impact on drug response in vitro. Here, we investigated the effect on breast cancer survival of germline ... -
Regulatory aspects on quality of life measurements
Taylor & Francis Verlag | 1992|Quality of life measurements have become important in clinical drug trials together with the traditional outcomes efficacy and safety
... -
Clarifying the Discussion Points in New Drug Application Reviews for Approval in Japan by a Government Advisory Council
Online Contents | 2017|Background In Japan, the Pharmaceutical Affairs and Food Sanitation Council (PAFSC) of the Ministry of Health, Labour and Welfare conducts ...Publisher: Springer International Publishing, Springer Nature, [New York]Keywords: regulatory science, new drug applications -
The European Regulatory Issues on Quality of Life Assessment Group Guidance: Some Critical Comments
Online Contents | 2003|Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
10th international symposium on the synthesis and applications of isotopes and isotopically labelled compounds—WBA–new methods and applications and WBA–instrumentation and regulatory, Sessions 5 & 6: Monday, June 15, 2009
Wiley | 2010|Predicting human radiation Dosimetry for clinical radiolabelled drug development studies was discussed
... -
Principles for Effective Regulatory Active Pharmaceutical Ingredients Policy
Online Contents | 1999|pharmaceutical ingredients (API) policy/practices of individual companies, as well as of the Food and Drug Administration (FDA) itself. These principles ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
On the Amendments of China’s Provisions for Drug Registration
Online Contents | 2008|emphasis on creating a high standard for drug safety by improving supervision of the registration process and upgrading drug evaluation and ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Evaluation of drug‐induced QT interval prolongation in animal and human studies: a literature review of concordance
Wiley | 2015|model during non‐clinical drug development. The importance of QT liability detection has been reinforced by non‐clinical [International ... -
Outsourcing Regulatory Activities: How a Policy Can Drive Good Decisions
Online Contents | 2000|outsourcing a large volume of drug development activities to contract research organizations (CROs). These organizations allow companies to access ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Commentary: Outsourcing of Regulatory Activities: How A Policy Can Drive Good Decisions
Online Contents | 2000|Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Transparency in Drug Submission Processes of 3 Asian Countries: A Survey of Industry Views
Online Contents | 2012|regulatory professionals responsible for international drug registration. Respondents viewed the US as most transparent, South Korea as intermediate ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Regulatory Submissions: From Canda/Capla to 2002 and Beyond
Online Contents | 2000|Abstract Vast amounts of scientific information and scientific-regulatory documentation are generated in the biopharmaceutical industry ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif.
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