Pharma Blog
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
Assessing Immunogenicity Risk of Peptides
Immunogenicity risk assessment is crucial in developing highly purified synthetic peptide drug products, especially when referencing recombinant DNA (rDNA)-origin biologics. The FDA’s Synthetic Peptide Guidance and Product-Specific Guidances (PSGs) provide a structured approach to evaluating these risks and ensuring generic peptide safety and efficacy. Key Takeaways from the Guidance & ... 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
Critical Processing Parameters in the Fabrication of PLGA Microparticles
Introduction Poly(lactic-co-glycolic) acid (PLGA) microparticles have gained significant attention as controlled drug delivery systems. Despite their potential, the translation of these systems from research to FDA-approved products remains limited. A major challenge lies in understanding the critical processing parameters (CPPs) that influence their fabrication and scale-up. A recent study by ... Read More
General Adverse Events in Clinical Trials
FATIGUE: Persistent tiredness not relieved by rest. FEVER: Elevated body temperature due to infection or inflammation. HEADACHE: Pain or discomfort in the head or upper neck. DIZZINESS: A feeling of lightheadedness or unsteadiness. NAUSEA: Sensation of wanting to vomit. VOMITING: Forceful expulsion of stomach contents. DIARRHEA: Frequent, watery bowel movements. ... 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