Industrial Pharmacy

Drug Development Stages

The stages of drug development are Discovery, Product characterization, Formulation, Delivery, Packaging Development, Pharmacokinetics and drug deposition, Preclinical Toxicology Examination and IND Application, Bio analytical Testing, Clinical Trials.

Computational drug discovery is an effective strategy for accelerating and economizing drug discovery and development process. Because of the dramatic rise in the availability of biological macromolecule and small molecule information, the applicability of computational drug discovery has been extended and broadly applied to nearly every stage in the drug discovery and development workflow, including target identification and validation, lead discovery and optimization and preclinical tests. Formulation development is the process in which different chemical substances, including the active drug, are mixed to produce a final medicinal product. Formulation studies involve developing a preparation of the drug which is both stable and acceptable to the patient. Reformulation involves the characterization of a drug's physical, chemical, and mechanical properties in order to choose what other ingredients (excipients) should be used in the preparation. Formulation studies consider factors such as particle size, polymorphism, pH, and solubility, as all of these can influence bioavailability and hence the activity of a drug. Drug design, sometimes referred to as rational drug design or simply rational design, is the inventive process of discovering new medications based on the knowledge of a biological target. The drug is most commonly an organic small molecule that activates or inhibits the function of a biomolecule such as a protein, which in turn results in a therapeutic benefit to the patient. In the most basic sense, drug design and discovery involves the design of molecules that are complementary in shape and charge to the bimolecular target with which they interact and therefore will bind to it. Drug design frequently but not necessarily relies on computer modelling techniques. This type of modelling is often referred to as computer-aided drug design. Finally, drug design that relies on the knowledge of the three-dimensional structure of the bimolecular target is known as structure-based drug design. Major type of drug designing is ligand-based drug design and the second, is structure-based drug design. Pharmaceutical research and development begins with the drug discovery phase. Typically, at this stage, chemical compounds — either naturally occurring (called biologics) or synthetic — are investigated in laboratory settings for their potential to bind. Once promising candidates are identified, preclinical trials begins. In this stage, actual drug development begins and pharmacological studies are carried out. Basically that research focuses on how the drug candidates react when delivered to the body. Then clinical trials are carried out. Candidate drug must pass through before it can be considered for market approval. Accerlated pharmacy programs will also be conducted.