What is an IND?
An IND is an Investigational New Drug Application that is required by a clinical study sponsor to obtain authorization from the Food and Drug Administration (FDA) to perform human clinical studies for investigational drug or biological product. This is federally mandated, and the requirements are set forth in 21 CFR Part 312. Why are INDs […]
CDMO vs CMO vs CRO: Key Differences
In the pharmaceutical industry, CROs refer to contract research organizations that provide clinical trial services and non-clinical toxicology services to clients. On the other hand, CMOs and CDMOs refer to Contract Manufacturing Organizations and Contract Development and Manufacturing Organizations that primarily provide drug manufacturing and drug development services. For small or mid-sized pharma companies looking […]
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 […]
Patient Compliance Through Drug Delivery Systems
Lack of patient compliance in medication is a major cause of poor health outcomes. There are a variety of reasons that contribute to this lack of patient compliance. Forgetfulness, adverse side effects, lack of access to medicine, high cost, inability to swallow large tablets or capsules, fear of needles, and poor taste are all reasons […]
What is CMC?
In the pharmaceutical industry, CMC stands for Chemistry Manufacturing and Controls. Quality and consistency of medicines is the primary responsibility and focus of the CMC function. The FDA regulates all CMC requirements for the pharmaceutical industry, which covers all aspects of drug substance and drug product chemistry, manufacturing, and quality control (QC). CMC consists of […]
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 […]