Analysis of Particle Size Distribution D10/D50/D90
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 …
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 …
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 …
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 …
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 …
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 …
What is stability testing of new drug substances and products Stability testing of new drug substances and products the purpose of this communication is to …
ASEAN common technical dossier (ACTD) for the registration of pharmaceuticals for human use: ASEAN Common Technical Dossier (ACTD) serves as a standardized framework for preparing …
Procedure for export of Indian drug product in overseas market Procedure for export of pharmaceutical products Background pharmaceutical Procedure for export of pharmaceutical Indian drug …
Regulatory Approval Process for Investigational New Drug (NDA-24) Background Investigational New Drug Investigational New Drug The drug approval process involves a regulatory pathway through which …