NanoViricides Inc. (NNVC)

[changes_iv]

Pre-clinical development: GLP vs. GMP

In drug development, pre-clinical development, also named preclinical studies and nonclinical studies, is a stage of research that begins before clinical trials (testing in humans) can begin, and during which important feasibility, iterative testing and drug safety data is collected.

The main goals of pre-clinical studies are to determine a product's ultimate safety profile. Products may include new or iterated or like-kind medical devices, drugs, gene therapy solutions, etc.

source: http://en.wikipedia.org/wiki/Pre-clinical_development

GMP vs GLP

• GMP and GLP are regulations imposed by FDA on manufacturers of healthcare products to ensure high quality and integrity of products

• While GMP pertains to goods that are intended for human use, GLP refers to laboratory practices

• GMP was introduced before GLP

• GLP is less costly and cumbersome than GMP

• GMP regulations pertain to personnel, plant and machinery and production and packaging processes while GLP pertain to lab testing, manner of keeping records and data, and quality control during lab testing.

Read more: http://www.differencebetween.com/difference-between-gmp-and-vs-glp/#ixzz30GsHn7CB