What is In-Use Stability?
An in-use stability study is performed to evaluate the chemical, physical, microbiological, and functional integrity of a pharmaceutical product after it has been opened or used but before it expires. This test is used to establish the shelf life and storage condition recommendations for pharmaceutical products after the primary packaging is opened. For example, oral […]
Vici Health Sciences Expands Capabilities for Phase III and Commercial Manufacturing
Vici Health Sciences, a leader in pharmaceutical development and regulatory services, is proud to announce significant expansions to its service offerings in the Contract Development and Manufacturing Organization (CDMO) space. These new capabilities include Phase III clinical batch manufacturing and commercial product manufacturing, solidifying Vici’s position as a full-service CDMO. Comprehensive Solutions in Maryland With […]
Gels, Creams, Lotions, and Ointments: Key Benefits and Differences
Semi-solid dosage forms are a class of pharmaceutical formulations that exist in a state between solid and liquid, exhibiting characteristics of both. These dosage forms are widely used in various applications, particularly in topical and transdermal drug delivery. Semi-solid dosage forms, such as gels, creams, lotions and ointments, are topical formulations designed for application to […]
505(b)(1) vs 505(b)(2): Understanding the Key Differences in FDA Drug Approval Processes
The 505(b)(1) pathway is typically used for new drugs with active ingredients that the FDA has not previously approved. This pathway requires a full New Drug Application (NDA) supported by detailed safety and efficacy data from extensive preclinical and clinical trials conducted by or on behalf of the applicant. In contrast, the 505(b)(2) pathway allows […]
Tablet Defects and How to Overcome Them in Manufacturing
Oral solid dose formulations, like tablets and capsules, are the most popular dosage forms for pharmaceutical drugs in the US due to their high medication compliance amongst patients and low manufacturing cost. A bottle of tablets for a monthly prescription can sometimes be manufactured for as low as five dollars, a cost virtually impossible to […]
Understanding Bioequivalence in Generic Drug Approval
Well over 80% of medicine prescribed in the US by volume are generics. Generic substitution saves the US healthcare sector billions of dollars and makes many medicines affordable to patients. Per the US FDA, even drugs that contain the same active ingredients at the same strength utilizing the same route of administration are not considered […]
Integrating cGMP in Clinical Manufacturing
Quality and safety are of utmost importance, among other critical factors, when developing a new drug. But clinical and analytical departments sometimes struggle to decide at which phase cGMP should be incorporated. What is cGMP? The acronym cGMP stands for Current Good Manufacturing Practices. These are regulations that are enforced by the FDA to ensure […]
Essential ANDA Checklist: Key Steps to Streamline Your Filing Process
Abbreviated New Drug Applications (ANDAs) are submitted to the FDA to seek approval for marketing generic drugs to the US market. As listed by the current FDA GDUFA requirements, sponsors must pay $252,453 to the FDA just to file an ANDA. This filing cost is set to increase to $321,920 in 2025. If the FDA […]
Vici Health Sciences Expands Staff and Footprint in Maryland to Meet Growing Customer Demands
Elkridge, Maryland–(Newsfile Corp. – October 8, 2024) Vici Health Sciences, a leading provider of pharmaceutical formulation, analytical, and regulatory services, is pleased to announce a significant expansion of its staff and physical footprint in Maryland. The expansion is in response to increasing demand for the company’s comprehensive pharmaceutical development services, enabling Vici Health Sciences to […]
Clinical Manufacturing Explained: How CDMOs Support the Development of FDA-Approved Trial Materials
The development of clinical trial material (CTM) is a critical phase in the pharmaceutical industry, especially in preparation for human clinical trials. Whether it’s an active pharmaceutical ingredient (API), placebo, or comparator drug, these materials must meet stringent FDA requirements to ensure patient safety and trial efficacy. Contract Development and Manufacturing Organizations (CDMOs) are key […]