Regulatory Pharma Blogs
Bioequivalence Trial Information -SAHPRA GENERAL INSTRUCTIONS: Bioequivalence Trial Information Please review all the instructions thoroughly and carefully prior to completing the Bioequivalence Trial Information Form (BTIF). Provide as much detailed, accurate and final information as possible. Note that the greyed areas are NOT to be filled in by the applicant. Please state the exact location (Annex …
Clinical data management (CDM) Clinical data management (CDM) consists of various activities involving the handling of data or information that is outlined in the protocol to be collected/analyzed. CDM is a multidisciplinary activity. Introduction This module will provide an overview of clinical data management and introduce the clinical research database. By the end of this …
USFDA Guideline for : Clinical Investigations of Medical Products Involving Children USFDA Guideline on September 23, 2022, the US Food and Drug Administration issued a preliminary guidance concerning the ethical aspects of involving and safeguarding children in clinical trials. This guidance is expected to undergo finalization in the near future. Clinical studies involving children are …
Submitting data in the NeeS format – TGA -Australia The following guidance is intended for sponsors and manufacturers interested in providing data in the NeeS format for various types of products, including prescription medicines, biologicals, over-the-counter medicines, registered complementary medicines, assessed listed medicines, listed medicine ingredients, and master files. This version 1.1 of the guidance, …
Tech Innovations Exploring New Directn in Regulatory Affairs 2024 Tech Innovations on a global scale, the Life Sciences and Pharmaceutical sector continually integrates advanced technologies and innovative therapies to enhance the quality of medicines, medical devices, and biologics. However, existing regulatory frameworks struggle to keep pace with these evolving methods of diagnosis and treatment. To …
Shrimp exporters adhere to strict regulations for safety and aim for Rs 1 lakh crore in exports, according to officials. shrimp exporters Indian are placing a significant emphasis on ensuring the quality and safety of their products, with the goal of enhancing exports to reach a value of Rs one lakh crore. They are committed to …
Amazing application of artificial intelligence (AI) in the 2024 pharmaceutical industries Amazing application of artificial intelligence in pharma, throughout our journey, humanity has traversed a vast terrain in pursuit of understanding AI. Since the dawn of digitalization, mainstream media has portrayed artificial intelligence as a complex entity poised to tackle the existential challenges of human …
what are drugs designed by AI
What is Bioavailability and Bioequivalence Study? What is Bioavailability and Bioequivalence Study? Bioavailability refers to the proportion of a drug from a given dose that enters the bloodstream and the speed at which it reaches systemic circulation. Assessing bioavailability involves measuring drug concentrations in plasma or blood following standardized administration protocols, documented over time. These …
What is Drug products approval System Regulatory affairs in 2024 Authorization in drug products Drug products approval system Regulatory affairs, A medicinal product, whether intended for human or veterinary use, must obtain a valid Marketing Authorisation (MA) before it can be legally sold and supplied in the market. The entity holding the Marketing Authorisation, known …