Frequently Asked Question: Dissolution testing
Dissolution testing of pharmaceutical drug products is one of the most important tools during drug development and for quality assurance during quality control (QC) release testing. This testing is mandatory for all oral solid dose, oral semi solid dose, and oral suspension products. It is not required for drugs that are already in solution such […]
Controlled Release Explained
Controlled Release (CR) involves the application of one or more polymer system to design a drug product that controls the drug release in a desired well characterized and reproducible manner. This results in drug entry into the systemic circulation within the specifications of the required drug delivery profile. Figure below compares plasma drug profiles for […]
Obstacles in Drug Development and How to Overcome Them
Drug discovery and development is a complex, expensive undertaking that can often end in failure to secure drug approval for critically needed medicines. The pre-clinical and clinical phase of drug development starts after target identification. During this phase, missteps in overall strategy, IND-enabling animal studies, lack of bioavailability or drug stability, formulation and manufacturing challenges, […]
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 […]
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 […]