Regulatory Pharma Blogs
Introduction of DMF/CEP :The Importance of Regulatory Submissions Introduction to DMF/CEP Introduction to DMF/CEP A Drug Master File (DMF) and Certificate of Suitability (CEP) are crucial documents in the pharmaceutical industry, ensuring the quality and safety of drug substances. The DMF is a confidential filing with the FDA that provides detailed information about the manufacturing, …
Skin Products: Quality and Similarity of Topically Applied, Locally Acting Skin Products Skin Products: The European Medicines Agency (EMA) has recently revised its guideline on Quality and Equivalence of Topically Applied, Locally Acting Skin Products. This updated document offers detailed standards regarding the quality and equivalence of skin products applied directly to the surface. It …
What is in-vitro-in vivo correlation (IVIVC) In-vitro-in vivo correlation (IVIVC) is a mathematical model that predicts the connection between an in vitro characteristic of a drug formulation and its corresponding in vivo effect. In the context of formulation development, the in vitro characteristic typically refers to dissolution or drug release, while the in vivo effect …
Analytical Methods Validation for Quality Assurance and Process Validation Experts Abstract:Analytical Methods Validation Analytical Method validation is a fundamental process in the pharmaceutical industry, essential for ensuring that analytical procedures used in testing are appropriate for their intended purposes. Validation data serve to confirm the performance, consistency, and reliability of these methods. This paper outlines …
USFDA Guidance: Incorporating Voluntary Patient Preference Information Throughout the Product Life Cycle The USFDA Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) have issued a draft guidance titled “Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle.” This document outlines when and how to gather …
Research and Development in the Pharmaceutical Industry Research and development in the pharmaceutical industry is an intricate and exciting path from idea to implementation. It’s the intersection of science and innovation, leading to significant medical advancements. This process includes a series of systematic steps focused on discovering, developing, and introducing new drugs to the market. …
3D Printing technology in Pharmaceuticals 3D Printing technology in Pharmaceuticals: Additive manufacturing, commonly known as 3D printing, is making significant strides in the pharmaceutical sector. This innovative technology allows for the creation of complex drug formulations and customized medications tailored to individual patient needs. By using layers of material to construct products, 3D printing improves …
What is Good Laboratory Practice (GLP) Good Laboratory Practice (GLP): The Principles of Good Laboratory Practice (GLP) set forth guidelines and standards for a quality system that manages the processes and conditions involved in planning, conducting, monitoring, recording, reporting, and archiving non-clinical health and environmental safety studies. These principles are applied to the non-clinical safety …
Akums Drugs and Pharma shares surge by 7% after listing. Should you buy, sell, or hold? Akums Drugs Shares Akums Drugs Shares of Akum Drugs & Pharmaceuticals had a subdued debut on Dalal Street on Tuesday, listing at Rs 725 on the NSE, which is a modest 6.77% premium over its issue price of Rs …
Regulatory Concepts Basic terminology,Guidelines, Regulations Regulatory Concepts Investigational Product Guidelines, Regulations Regulatory Concepts A newly developed medication created by a manufacturer.Basic terminology Phase III Clinical Study A randomized trial conducted by the manufacturer to evaluate the benefits and risks of an investigational product. Active Comparator (Active Treatment or Active Control) An effective medical treatment used …