Industrial Pharmacy
Level II Biorelevant Media
Developing accurate models of the gastrointestinal (GI) tract is paramount in pharmaceutical research to predict how drugs interact with the human body. Level II biorelevant media emerges as a sophisticated tool to mirror the intricate conditions within the GI system, playing a pivotal role in enhancing drug formulation and assessment. ... Read More
Level I Biorelevant Media
When studying drug dissolution in the gastrointestinal (GI) tract, simulating realistic physiological conditions is crucial for accurate results. Enter Level I biorelevant media – a novel approach to create in vitro environments that closely mimic luminal pH and buffer capacity in different regions of the GI tract. At Level I, ... Read More
Level 0 Biorelevant Media
Biorelevant media were initially proposed in 1998 to study the dissolution of poorly soluble drugs in the gastrointestinal (GI) tract. Over time, different media have been developed to mimic various parts of the GI tract in both fasted and fed states. For the fasted state, there are specific biorelevant media ... Read More
Teriparatide Injection’s Generic Approval and FDA Quality-Related Review
Introduction to Teriparatide and its Generic Approval Teriparatide, a peptide-based drug consisting of 34 amino acids with a molecular weight of 4117.8 daltons, is primarily indicated for treating osteoporosis. Its formulation comes as a clear solution in a multi-dose injector pen for subcutaneous injection. Teriparatide is administered daily in a ... Read More
Common Deficiencies in ANDA Submissions for Peptide Drugs
The FDA highlights several common deficiencies observed in the review of peptide-based generic drugs, including Teriparatide: Impurity Profiles Not Up to Date: Manufacturers often submit impurity profiles based on products aged at release. The FDA recommends that profiles also include data from samples aged at the end of the proposed ... Read More
Addressing Immunogenicity Concerns and Impurity Profiling for Peptide Drugs
Immunogenicity, or the potential to trigger immune responses, is a critical concern for peptide drugs like Teriparatide. Impurities, aggregates, or contaminants in peptide-based generics could lead to unwanted immune reactions. Thus, the FDA recommends evaluating both the innate and adaptive immune responses when developing a generic peptide. Innate Immune Response: ... Read More
Drug-Device Combination Products | Innovations and Compliance
In the ever-evolving landscape of medical technologies, drug-device combination products represent a cutting-edge integration of drugs, medical devices, and biologics. These products offer innovative solutions for disease management, but they also demand a robust understanding of regulatory frameworks and compliance to ensure safety, efficacy, and quality. What Are Combination Products? ... Read More
QMS in Pharmaceutical Industry
A Quality Management System (QMS) is a formalized framework that outlines the structure, responsibilities, and processes for achieving quality objectives in an organization. The QMS ensures that products or services meet customer and regulatory requirements. Content of a QMS: A typical QMS consists of the following elements: Quality Policy: A ... Read More
Navigating Bioequivalence Study Guidelines Across Global Regulatory Bodies
When conducting bioequivalence (BE) or bioavailability (BA) studies for regulatory approval, guidelines from different regulatory bodies must be adhered to. Here’s a summary of the key considerations and variations across major regulatory agencies Regulatory Guidelines Comparison USFDA Special Cases: Study Design: EMA Acceptance Range: Study Design: WHO Study Design: MHRA ... Read More
Understanding Patent Length and Generic Competition in Pharmaceuticals
Hello everyone! I’ve been preparing to share more insights on pharmaceutical regulations in the future, and today I’ve learned about patents, FDA approvals, and how generics enter the market. How Patent Protection Works Patent Duration FDA Approval Time What Happens After the Patent Expires? Generic Drug Applications Market Exclusivity for ... Read More
Importance of Drug Optimization
Let’s talk about the importance of “Drug optimization” which is a crucial concept in medicinal chemistry and drug design. It refers to the strategy of replacing one chemical group with another that has similar biological activity but different pharmacokinetic properties. For example, consider two NSAIDs available in the market which ... Read More