Pharma Digest
Solubility Enhancement Techniques for BCS Class II Molecules
For BCS Class II drugs, which have low solubility but high permeability, formulation efforts center on enhancing solubility to improve bioavailability. Here’s how we turn API properties into actionable formulation strategies: Solubility Improvement With BCS Class II drugs’ low solubility, enhancing solubility is key for bioavailability. Techniques include: Particle Size ... Read More
Formulation Development Strategy for BCS Class I Molecules
For BCS Class I drugs, with high solubility and high permeability, formulation strategies across various dosage forms are generally more straightforward than for other BCS classes. These drugs can dissolve and permeate easily, meaning that the focus is typically on optimizing stability, dosage form design, and patient compliance rather than ... Read More
Importance of Understanding the Biopharmaceutics Classification System
Guides Formulation Strategy: The BCS class helps in identifying the solubility and permeability characteristics of the drug. Drugs in different classes require distinct formulation approaches. For example, a poorly soluble drug (BCS Class II or IV) may need solubility enhancement techniques like solid dispersions or nano-formulations. Predicts Drug Absorption and ... Read More
Role of Standard Operating Procedures (SOPs) in Pharmaceutical QA
Introduction In the pharmaceutical industry, Standard Operating Procedures (SOPs) play a vital role in ensuring quality assurance (QA). SOPs provide a systematic approach to performing tasks, minimizing errors, and ensuring compliance with regulatory requirements. In this blog, we’ll explore the importance, benefits, and best practices of SOPs in pharmaceutical QA. ... Read More
Cluster Development Program (CDP) & Data Governance
In the pharmaceutical industry, data governance is crucial for ensuring the quality, integrity, and compliance of data. The Cluster Development Program (CDP) is a framework that enables companies to implement data governance effectively. In this blog, we’ll explore why CDP and data governance are mandatory in the pharmaceutical industry and ... Read More
Re-Validation in Computerized System Validation (CSV)
In Computerized System Validation (CSV), revalidation refers to the process of re-assessing and re-qualifying a system after significant changes or events that may impact its validated state. It ensures that the system continues to operate as intended and in compliance with regulatory requirements. Revalidation is often required in the following ... Read More
Validation of a SCADA System Within CSV
Steps in SCADA (Supervisory Control and Data Acquisition) System Validation: Read also: Resource Person: Mohamed Mahmoud
Particle Size Distribution (PSD) Requirements for Different Dosage Forms
Immediate-Release Tablets Controlled-Release Tablets Oral Suspensions Inhalation Formulations Topical Creams/Ointments Injectables (Parenterals) Practical Steps for PSD Optimization Read also: Resource Person: Moinuddin Syed. Ph.D, PMP
US FDA Inspection and SMEs Role
Before Inspection During Inspection Key Phrases Best Practices Common FDA Inspection Questions After Inspection Additional Tips By following these guidelines, SMEs can effectively communicate with US FDA inspectors. Read also: Resource Person: Rajesh Jain
Legal Basis for Marketing Authorization in the EEA
Navigating the regulatory landscape for drug approval in the European Economic Area (EEA) can be complex. There are multiple legal pathways, each with its own requirements, especially around clinical studies. Here’s a quick snapshot: Full Applications (Article 8(3) of Directive 2001/83/EC) require comprehensive clinical data for new products. Generic Applications ... Read More
FDA NDA Classification Codes
Understanding New Drug Application (NDA) Classification Codes is crucial for setting clear regulatory and development timelines. These codes help the FDA categorize new drugs based on their relationship to previously approved therapies. The numerous acronyms used by the FDA, along with their distinct meanings, can be quite confusing. Beyond its ... Read More