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 […]
What is Oral Solid Dosage (OSD): A Comprehensive Guide to OSD Formulations
Oral solid dosage (OSD) refers to a finished drug product that is available in solid form intended to be administered through the oral cavity. These are available as unit doses which contain a precise amount of drug substance in a variety of forms such as tablets, capsules, powders, granules and troches. Why OSDs? Oral solid […]
Why Your Early-Stage Drug Development Needs an R&D-Focused CDMO Partner
Early-stage drug development is best performed at an R&D-focused CDMO. Initial formulation and small batch manufacturing for proof-of-concept clinical trials require speed, agility, and cost-effectiveness as opposed to the scale of a Phase III or routine commercial manufacturing-focused CMO. Preclinical work in early-stage drug development encompasses the following: These activities must generally be completed prior […]
From R&D to Quality Control (QC): Developing QC-Friendly Analytical Methods
Quality control is an integral part of the drug development process, and the quality of analysis can make a difference in a drug product’s safety and efficacy. QC-friendly analytical methods are simple to operate and require minimum sample preparation. They are robust, reliable, and efficient for routine analytical tests. Furthermore, the analytical tests run by […]
Phase-Appropriate Validation: How Tailored Approaches Support Cost-Effective Drug Development
Drug development is a complex and highly regulated process that necessitates ongoing validation to ensure drug product safety and efficacy. A phase appropriate method validation technique is applied at each step of drug development; with flexibility being provided in the initial stages where the methods can change. As the phases advance toward clinical use, strict […]
Non-Clinical (animal) IND Enabling Studies: What You Need to Know
In drug development, IND enabling studies serve as a vital link between drug discovery research and the start of human clinical trials. These studies are used to compile evidence which shows a New Chemical Entity (NCE) is safe and effective before it is tested on people. Generally, they are also needed for 505(b)(2) product development, especially when a […]
Key Pharmacokinetic Factors in Topical Medication Development
Topical drug products are designed to deliver active ingredient on the skin or mucous membranes, primarily intended for topical application and to exert local therapeutic effects. Topical drug products are available in the market in the form of creams, gels, ointments, and patches. Recently in the world of pharmaceutical industry, topical drug products have emerged […]
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 […]