Basic Research: The term basic research refers to study and research on pure science that is meant to increase our scientific knowledge base. This type of research is often purely theoretical with the intent of increasing our understanding of certain phenomena or behavior but does not seek to solve or treat these problems.
Translational Research: Is a way of thinking about and conducting scientific research to make the results of research applicable to the population being studied. It is used to translate the findings in basic research more quickly and efficiently into medical practice and, thus, meaningful health outcomes, whether those are physical mental or social outcomes. It has been applied to a research approach that seeks to move “from bench to bedside” or from laboratory experiments through clinical trials to actual point-of-care patient applications. Translational research has proven to be a powerful process that drives the clinical research engine.
RFP's: A request for proposal is an early stage in a procurement process, issuing and invitation for suppliers, often through a bidding process, to submit a proposal on a specific commodity or service. The RFP process brings structure to the procurement decision and allows the risks and benefits to be identified clearly upfront. They typically reflect the strategy and short/long-term business objectives, providing detailed insight upon which suppliers will be able to offer a matching perspective.
Biomarker: Is a term often used to refer to a protein measured in blood whose concentration reflects the severity or presence of some disease state. More generally a biomarker is anything that can be used as an indicator of a particular disease state or some other biological state of an organism. Biomarkers have been used in pre-clinical research and clinical diagnosis for a considerable time. They bring the future things in our hand by helping in early diagnosis, disease prevention drug target identification, drug response etc. Some of the main areas in which molecular biomarkers are used in the drug development process are: Early drug development studies, safety studies, Proof of concept studies, Molecular profiling.
Indications: An indication is a valid reason to use a certain test, medication ,procedure, or surgery. In the U.S. indications for medication are strictly regulated by the Food and drug Administration, which includes them in the package insert under the phrase "indications for usage".
Drug Discovery: Drug discovery programs are initiated and driven by the belief that an efficacious new drug can be identified and made available to suffering human patients. The positive signals and data for efficacy drive the program forward. In contrast, in the phase of selecting and characterizing a clinical drug candidate, the focus must be on human safety. Because of several incidents of unpredicted toxicity observed in human studies in recent years, the regulatory agencies and public demands for safety are stricter than ever before. Safety issues and concerns require the highest attention when identifying a clinical drug candidate.
Contract Research Organization (CRO): Is a service organization that provides support to the pharmaceutical and biotechnology industries. CRO’s offer clients a wide range of “outsourced” pharmaceutical research services to aid in the drug and medical device research and development process.
Lead molecules: Are defined as an electrically neutral group of at least two atoms in a definite arrangement held together by very strong chemical bonds. Molecules are the smallest particles of pure chemical substances that still retain their composition and chemical properties. They cannot be seen with the naked eye.
Candidate Stage: The path from lead to clinical drug candidate represents the most idiosyncratic segment of drug discovery and development. Each program is unique and setbacks are common, making it difficult to predict accurately the duration or costs of this segment. Because of the incidents of unpredicted human toxicity seen in recent years, the regulatory agencies and public demands for safety of new drug candidates have become very strict, and safety issues are dominant when identifying a clinical drug candidate. The overall pathway is structured by well-delineated milestones, which include selection of the drug target, identification of a lead compound, its modification to a compound suitable of toxicity testing in animals, and selection as a drug candidate for clinical testing. Although the road is well mapped out, it is by no means easy or guaranteed to end in success. It must bind selectively to the receptor site on the target and elicit the desired functional response from the target molecule. It must have sufficient bioavailability and distribution within the body to reach the receptor site, and it must elicit the desired responses in vivo, in animal models of the human disease. Most importantly, a drug candidate suitable for testing in humans must pass a formal toxicity evaluation in animals, to demonstrate that humans participating in the clinical studies are exposed to minimal risks only.
Proof of Concept: Is a short and/or incomplete realization (or synopsis) of a certain method or idea(s) to demonstrate its feasibility, or demonstrate in principle, whose purpose it is to verify that some concept or theory is probably capable of being useful. The proof of concept is usually considered a milestone on the way to a fully functioning prototype.
Pharmacokinetics (PK): Describes what the body does to a drug. PK is dependent on the dose administered, site of administration, and physiological state of the organism. A typical PK study involves administering a fixed amount of the drug (the dose) to the subject (human or animal) and at various times post dose, samples of an easily accessible tissue (usually blood/plasma) are drawn and collected for analysis of the drug and its metabolite concentrations. These concentration values are plotted against the sampled times then the data are mathematically analyzed to yield parameters that are associated with the disposition of the drug.
Pharmacodynamics (PD): Is the division of pharmacology concerned with the action and breakdown of drugs in the body. It explores what a drug does to the body, the mechanisms of drug action and the relationship between drug concentration and effect.
Drug Efficacy: Indicates the capacity for beneficial change (or therapeutic effect) of a given intervention (e.g. a medicine, medical device, surgical procedure, or a public health intervention.) If efficacy is established, an intervention is likely to be at least as good as other available interventions, to which it will have been compared.
Compounds: Is a pure chemical substance consisting of two or more different chemical elements that can be separated into simpler substances by chemical reactions. They have a unique and defined chemical structure; they consist of a fixed ratio of atoms that are held together in a defined spatial arrangement by chemical bonds.