FRD
Key Considerations for Generic Formulation Development
Generic formulation development is a complex process designed to create bioequivalent, cost-effective alternatives to innovator products while meeting regulatory standards. Below are the critical aspects to consider: Regulatory Compliance Ensure adherence to market-specific regulatory guidelines, such as those of USFDA, EMA, or MHRA, to obtain approval for generic products. Bioequivalence ... Read More
Drug Excipient Compatibility Study During QbD
To perform Drug-Excipient Compatbility (DEC) study 4 types of samples are required to be preprared: All these samples are packed in flint glass vial or amber color vial (if API is light sensitive) with and without sealing & exposed for a particular time period i.e. 1 Day, 3 Days, 7 ... Read More
Quality by Design (QbD) in Pharmaceutical Development
Quality by design (QbD) is a scientific and risk-based approach to pharmaceutical product development that begins with predefined objectives. Instead of relying on finished product testing alone, QbD ensure the product quality throughout the development process. Objective of QbD Approach Elements of QbD QbD comprises different elements of pharmaceutical development ... Read More
Excipients in Pharmaceutical Applications
Pharmaceutical excipients are used in virtually all drug products and are essential for drug product manufacturing and performance. Thus, the successful manufacture of a robust product requires the use of well-defined excipients and manufacturing processes that consistently yield a quality product. The intended end use of the excipient should be ... Read More
Literature Review in Pharmaceutical Product Development
The literature review is an important part of pharmaceutical product development demonstrating literature based knowledge and understanding of the target drug product. The objective of this study is to find out the development and manufacturing feasibility of the product. A list of information to be collected during literature review are ... Read More
How to Increase Solubility of Drug?
The solubility of drug molecule is one of the most challenging aspect in formulation development. It is crucial to ensure the right concentration of a drug gets into the bloodstream so the bioavailability of the drug causes the desired pharmacological response. Therefore, using a variety of techniques to improve solubility ... Read More