Search results
Results from the WOW.Com Content Network
In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.
European Union: In the EU, Good Clinical Practice is backed and regulated by formal legislation contained in the Clinical Trial Regulation (Officially Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC). [3]
The use of high-quality research to establish the guidelines for best practices defines evidence-based practice. In essence, evidence-based dentistry requires clinicians to remain constantly updated on current techniques and procedures so that patients can continuously receive the best treatment possible.
Pulp capping is a technique used in dental restorations to protect the dental pulp, after it has been exposed, or nearly exposed during a cavity preparation, from a traumatic injury, or by a deep cavity that reaches the center of the tooth, causing the pulp to die. [1]
In the United States, DMFs are submitted to the Food and Drug Administration (FDA). The Main Objective of the DMF is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal product for obtaining an Investigational New Drug Application (IND), a New Drug Application (NDA),As an Abbreviated New Drug Application (ANDA), another DMF, or an Export Application.
Dental implants [3] is one of the most advanced dental technologies in the field of dentistry. Certification in the dental laboratory profession is strictly voluntary. Laboratories who have taken the extra steps to become certified represent the top of their field. The most easily obtainable certification is the CDL (Certified Dental Laboratory).
Safety monitoring procedures; An IB contains a "Summary of Data and Guidance for the Investigator" section, of which the overall aim is to "provide the investigator with a clear understanding of the possible risks and adverse reactions, and of the specific tests, observations, and precautions that may be needed for a clinical trial.
Dental anesthesia (or dental anaesthesia) is the application of anesthesia to dentistry. It includes local anesthetics , sedation , and general anesthesia. Local anesthetic agents in dentistry