This stage starts with target identification. A biochemical mechanism established in a disease condition is chosen. Thomas (137) establishes that drug candidates, discovered in biotech/pharmaceutical research labs are tested for their contact with the drug target. Numerous molecules for all potential drug candidates undergo rigorous screening process. This may include functional proteomics and/or genomics among other screening methods. After confirming interaction with target drug, they classically validate that target through checking for activity versus disease condition that the drug in being developed. After vigilant review, one or several lead compounds are chosen. There is no specified duration of time for the discovery stage.
Product Characterization
After choosing a candidate molecule that has shown therapeutic significance, it is characterized on the basis of molecule size, strength, shape, and weakness, toxicity, determined bioavailability, preferred conditions for maintaining function, and bioactivity. The early stage pharmacology studies assist in characterizing the fundamental mechanism of action of the chosen compound.
Formulation, Delivery, Packaging Development
Drug developers devise a formulation in order to ensure proper drug delivery parameters. This process of formulation and delivery is refined constantly until drug approval. it is the scientists that determine drug stability, including all parameters involved with shipment and storage.
Pharmacokinetics and Drug Disposition
Pharmacokinetic (PK) studies provide helpful feedback for formulation professions. Pharmacokinetic studies yield parameters like Area under the Curve (AUC), Maximum concentration of drug in blood (Cmax) and time when Cmax is reached (Tmax).
Preclinical Toxicology Testing and IND Application
This stage analyzes the safety, bioactivity, and effectiveness of the formulated drug product. The stage is critical to the eventual success of the drug. At this stage the application of Investigative New Drug (IND) are prepared. It takes duration of 120 days.
Bioanalytical Testing
This stage supports most activities on other activities in the development of the drug. The bioanalytical work is fundamental to appropriate categorization of the molecule, assay development, determining process yields, development of optimal methods for cell fermentation of culture and provision of quality control and quality assurance for the whole development process. It takes duration of 70 days.
Clinical Trials
Clinical trials are grouped in three objective phases:
- Clinical Development: 30days after IND is filed by the biopharmaceutical company
- Phase II Clinical Development: small-scale trials that evaluate the drug’s prelude effectiveness as well as, side-effect profile in approximately 100 to 250 patients.
- Phase III Clinical Development: extensive clinical trials for safety and effectiveness in massive patient populations.
There is no specific duration for this stage; for example an average of 8years can be taken for a cancer clinical trial before the drug is approved.
-Work cited-
David Pelletier. FDA’s regulation of genetically engineered foods: Scientific, legal and political dimensions Original Research Article. Food Policy, Volume 31, Issue 6, December 2006, Pages 570-591
Jennifer K. Wagner. Understanding FDA Regulation of DTC Genetic Tests within the Context of Administrative Law. The American Journal of Human Genetics, Volume 87, Issue 4, 8 October 2010, Pages 451-456
Thomas M. Tsakeris. Impact of new FDA regulations and policies on commercial clinical microbiology laboratory tests. Clinical Microbiology Newsletter, Volume 20, Issue 16, 15 August 1998, Pages 137-140
