Introduction of DMF/CEP : The Importance of Regulatory Submissions
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 …
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 …
Analysis of Particle Size Distribution D10/D50/D90 Analysis particle size distribution is crucial for quality control and research, as it directly impacts various material properties. These …
EMA Guidelines: Quality and Similarity of Topically Applied, Locally Acting Skin Products Skin Products: The European Medicines Agency (EMA) has recently revised its guideline on …
Data Requirements for Step 2: Preclinical Studies 7.1 Prerequisites for Conducting Preclinical Studies Preclinical studies Before initiating preclinical studies, the applicant must adhere to RCGM …
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 …
Principles for Development of Biologics Similar Biologics Similar biologics are created through a systematic process aimed at demonstrating their similarity to a reference biologic by …
Analytical Methods Validation for Quality Assurance and Process Validation Experts Abstract:Analytical Methods Validation Method validation is a fundamental process in the pharmaceutical industry, essential for …
Nitrosamine “USFDA Guidelines: Managing Nitrosamine Contaminants in Human Medications” Nitrosamine Earlier today (September 4, 2024), the Center for Drug Evaluation and Research of the U.S. …
SAHPRA South Africa: eCTD Compliance and Technical Review for Renewal Applications – Template SAHPRA South Africa The South African Health Products Regulatory Authority (SAHPRA) has …
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 …