Data Requirements for Step 2: Preclinical Studies
Data Requirements for Step 2: Preclinical Studies Preclinical Studies 7.1 Prerequisites for Conducting Preclinical Studies Preclinical studies Before initiating preclinical…
What is in-vitro-in vivo correlation (IVIVC)-Q6A
What is in-vitro-in vivo correlation (IVIVC) In-vitro-in vivo correlation (IVIVC) is a mathematical model that predicts the connection between an…
Biologics Similar Principles for Development of Biologics Similar-No. 977
Biologics Similar: Principles for Development of Biologics Similar Biologics Similar biologics are created through a systematic process aimed at demonstrating…
Analytical Methods Validation for Quality Assurance and Process Validation Experts
Analytical Methods Validation for Quality Assurance and Process Validation Experts Abstract:Analytical Methods Validation Analytical Method validation is a fundamental process…
Nitrosamine USFDA Guidelines: Managing NDMA Contaminants in Human Medications
Nitrosamine USFDA Guidelines: Managing Nitrosamine Contaminants in Human Medications Nitrosamine Earlier today (September 4, 2024), the Center for Drug Evaluation…
SAHPRA South Africa : eCTD Compliance and Technical Review for Renewal Applications-2024
SAHPRA South Africa: eCTD Compliance and Technical Review for Renewal Applications – Template SAHPRA South Africa The South African Health…
USFDA Guidance: Using Patient Preference Info Across Product Life Cycle-2024
USFDA Guidance: Incorporating Voluntary Patient Preference Information Throughout the Product Life Cycle The USFDA Center for Devices and Radiological Health…