Drug product development

U.S. Laws and Regulations Related to Drug Product Development and Manufacture. Until early in the twentieth century, dmg products were made and sold in the United States having virtually no imposed control. QuaUty was generally poor. Many products were patent medicines of dubious value. Some were harmful and addicting. 

The intrinsic dissolution rate is the rate of mass transfer from the solid phase to the liquid phase. Information on the intrinsic dissolution rate is important in early drug product development. It has been suggested that drugs with intrinsic dissolution rates of less than 0.1 mg/(min cm2) will have dissolution rate-limited absorption, while drugs with intrinsic dissolution rates greater than 0.1 mg/ (min cm2) are unlikely to have dissolution rate problems. 

Integrated Drug Product Development — From Lead Candidate Selection to Life-Cycle Management... 

ROLE OF CE IN DRUG SUBSTANCE AND DRUG PRODUCT DEVELOPMENT... 

Hard shell capsules occupy a central role in drug product development and manufacture, ranking second behind compressed tablets in frequency of utilization in drug delivery. In product development, such capsules are often the first dosage form for any orally administered drug substance. Although the expectation may be that the final marketed form will be a compressed tablet, firms may consider using the capsule as the first marketed form to shorten the overall development cycle. 

Supercritical Fluid Technology for Drug Product Development, edited by Peter York, Uday B. Kompeiia, and Boris Y. Shekunov... 

Generic Drug Product Development Solid Oral Dosage Forms, edited by Leon Shargel and Izzy Kanfer... 

Interfaces with external professional regulatory and scientific groups, makes presentations, and participates in workshops to promote and enhance botanical drug product development and knowledge. 

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