Regulatory Pharma Blogs
Data Requirements for Step 2: Preclinical Studies Preclinical Studies 7.1 Prerequisites for Conducting Preclinical Studies Preclinical studies Before initiating preclinical studies, the applicant must adhere to RCGM guidelines, which include demonstrating the consistency of the process and product, characterizing the product, and establishing product specifications. The applicant is required to submit generated data alongside essential …
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 …
Biologics Similar: 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 conducting thorough characterization studies of molecular and quality attributes. While the preclinical and clinical evaluation of a similar biologic may be less extensive than that of the reference, …
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 …
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. Food and Drug Administration issued an updated version of the guidance document titled \”Control of Nitrosamine Impurities in Human Drugs.\” This second revision provides detailed recommendations for both active pharmaceutical …
SAHPRA South Africa: eCTD Compliance and Technical Review for Renewal Applications – Template SAHPRA South Africa The South African Health Products Regulatory Authority (SAHPRA) has issued new instructions for \”eCTD Validation and Technical Screening for Renewals,\” tailored specifically for renewal processes. This updated guidance is essential for pharmaceutical companies aiming to keep their medicinal product …
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 …