Drug Products
Drug Products - Related Videos
01:16
Drug Product Stability
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2025
The long-term stability of drug products is critical to ensuring their quality, safety, and effectiveness over time. Stability directly influences a product's ability to maintain its intended characteristics, ensuring it performs as expected during its intended shelf life. Key attributes such as drug potency, impurities, dissolution, and other physicochemical measures of performance are tested to assess stability. These parameters indicate how well the product retains its quality over time and...
01:28
Drug Products: Biologics, Biosimilars and Interchangeables
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2026
Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
09:58
Robotic Production of Cancer Cell Spheroids with an Aqueous Two-phase System for Drug Testing
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Cited by 37 •
2015
A protocol for robotic printing of cancer cell spheroids in a high throughput 96-well plate format using an aqueous two-phase system is presented.
09:24
Application and Methodology of the Non-destructive 19F Time-domain NMR Technique to Measure the Content in Fluorine-containing Drug Products
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Cited by 2 •
2017
A simple and non-destructive technique that measures the average content of drug substances in formulated drug products containing fluorine using low-field fluorine-19 (19F) time-domain (TD) nuclear magnetic resonance (NMR) is presented here. The technique can be applied to the development and manufacturing of drugs in the pharmaceutical industry.
01:20
Drug Product Performance: In Vitro–In Vivo Correlation
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2025
In pharmaceutical development, it's crucial to establish a predictive in vitro–in vivo correlation (IVIVC) for two or more formulations to gain a comprehensive understanding of release properties. IVIVC reduces the need for costly in vivo studies and facilitates the establishment of meaningful dissolution specifications with significant cost savings and decreased regulatory burden. Furthermore, a meaningful IVIVC should predict Cmax and AUC within 20%, aligning with FDA guidance while adhering...
FAQs
Dosage form and route of administration shape how a drug product releases its active pharmaceutical ingredient and how that ingredient becomes available to the body. The formulation can influence dissolution, absorption, distribution, and how long drug levels are maintained. These relationships help clinical developers select an appropriate product design for the intended treatment and evaluate whether observed exposure matches desired therapeutic performance.
Excipients are considered alongside the active pharmaceutical ingredient because the complete formulation must deliver a defined dose safely and consistently. Their inclusion contributes to the product design that governs release, dissolution, and stability. During development, investigators therefore assess the finished formulation rather than focusing only on the active ingredient, linking composition to reliable clinical performance and manufacturing requirements.
Dissolution affects how a drug becomes available for absorption, while stability helps preserve the product's intended quality over time. Together, these properties connect formulation design with pharmacokinetics, including the drug's absorption, distribution, and maintenance in the body. Evaluating both helps determine whether a product can provide consistent exposure and support dependable therapeutic outcomes.
The choice among tablets, capsules, injections, and other dosage forms depends on how the product must deliver its dose and perform in the body. Each design can produce different relationships among release, absorption, distribution, and maintenance of drug levels. Clinical development uses these considerations, together with quality, safety, pharmacokinetic, and efficacy findings, to support formulation selection.
Clinical studies evaluate drug products through several complementary dimensions: quality, safety, pharmacokinetics, and therapeutic efficacy. Quality addresses whether the product remains suitable and consistent, pharmacokinetics examines its behavior in the body, and efficacy considers therapeutic performance. Reviewing these dimensions together helps determine whether the formulation provides reliable treatment outcomes and remains appropriate for further development.
Assessment begins with formulation and product design, followed by evaluation of quality, safety, pharmacokinetics, and therapeutic efficacy during development and clinical trials. Results from these assessments inform whether the chosen dosage form and route provide consistent performance. The evidence also supports manufacturing decisions and helps demonstrate alignment with regulatory requirements before broader clinical use.