Basic Facts to Know About Pharmacodynamics

While exploring the complexity of drug development, you can read about “Early Drug Development” concepts and the related procedures. Scroll down to know more about the various steps involved in drug development such as preclinical testing, investigational new drug (IND) applications, completed clinical testing before marketing approval from the FDA.

New drug development involves three stages: preclinical testing, clinical testing, and regulatory approval. The complexity of this process has increased manifolds with the increasing number of IND applications and completed clinical trials.

Our new drug development program is a perfect platform to fulfill your scientific and business goals. We offer multiple options including IND enabling studies, lead identification, optimization and profiling, IND preparation and development (including nonclinical, pharmacology, toxicology), regulatory affairs (including submission of an IND if needed) and more. Our new early phase drug development of personalized medicine approach helps provide better treatment options sooner by combining state-of-the-art therapeutic technologies with our experienced team.

The Early Drug Development (EDD) Service facilitates the rapid, efficient creation of new anticancer drugs. A key feature is our conduct of broad phase I trials across disease types and molecular targets. We work closely with the Drug Evaluation Group (DEG) to help ensure that trials are designed and conducted professionally and in a cost-effective way. We run broad phase I clinical trials across disease types includes children and adult patients with solid tumors. We evaluate drugs for safety: how the body processes a drug; and how the drug works in people. We also investigate how well a drug is tolerated: side effects, dosage, and patterns of use.

Pharmacokinetics (PK) is the analysis and description of the disposition of drugs in the body, encompassing development of the mathematical description of all dispositional processes in the body, defined as ADME – absorption, distribution, metabolism, and elimination.  Pharmacokinetics (PK) is a biological science conferring the detailed study of information found in the disposition of a drug in the body. The goal of PK research is to collect data on the absorption, distribution, metabolism, and elimination of a drug.

 PK and PD provide the mechanisms whereby drugs do what they do. PK describes the actions of drugs on the body, including how a drug is absorbed, distributed, metabolized, and eliminated. It is different from PD because it does not describe how the drug works in the body to create its therapeutic effect. Pharmacodynamics (PD) refers to the physiological response that occurs once a drug binds to its target receptor. The term includes: pharmacological effects, biochemical effect of drugs, pharmacokinetic studies of active substances in their healthy and pathological states. 

Drugs are risky. Investing in early drug development could be the most important decision you make this year for your company. As you design your new drug and as it is being tested, there are a lot of times when something could go wrong that would cause the entire project to fail. Every step is hugely important from idea to execution, and the results can mean life or death not only for you but possibly also the patients who put their life into your hands.