Drug development life cycle

Analytical methods are important not only in the development and manufacture of commercial biopharmaceutical drugs, they also play a vital role in the whole drug development life cycle. Drug discovery and preclinical research require development and application of analytical methodologies to support identification, quantitation, and characterization of lead molecules. It is difficult to perform a comparative potency assay on lead molecules if one does not know how much of each is going into the assay or how pure the molecule is. Analytical methods are typically developed, qualified, and validated in step with the clinical... 

Advance planning with development personnel can begin in many different ways. Typically, a project planning committee defines key stages in a new drug entity s life cycle. The committee will usually include the QA professional as a part of the team, which allows him or her to arrange a plan for monitoring the development life cycle from concept to submission. 

The GMP regulations apply to investigational new drug products produced for clinical trials in humans or animals, whereas those activities earlier in the product development life cycle such as basic research, discovery or preclinical experimentation are not subject to GMP requirements. 

Under the new paradigm for decision making, all decision makers will increasingly be forced to take into account the perspectives of the other players affected by their decisions. Prescribers will no longer consider just the clinical impact, but also the economic impact their decision will have on the payer, and the QOL impact the decision will have from the patient s perspective. The payer and patients will need to consider the impact of their decisions on the rest of the system. Successful drug developers now evaluate three-dimensional outcome data as early as possible in the product development life cycle. This information will also be useful to investors who are making decisions regarding the ultimate potential for success or failure of a newly discovered therapeutic product. 

First, the chapters here may be regarded loosely as the premarketing phases of a successful drug s life cycle. This not congruent with the whole of drug development. What is needed to get a drug approved is not the same as what is needed to make that drug into a commercial success. 

In general, the use of Bayesian network meta-analysis has broad applicability to evaluate AEs between related drugs. These methods can provide insight to prescribers and also assess cost-effectiveness. The direct probability statements that result from the Bayesian approach are helpful to decision makers evaluating a variety of medical products for a given therapeutic area/indication. Furthermore, the information obtained from the network meta-analysis can be utilized throughout the medical product development life cycle in simulations to design future clinical trials. 

To assist the reader with the question of which dissolution test to apply when the first part of this chapter is divided into two primary sections—one dealing with drugs that have few or no solubility problems, in which case developing dissolution tests at all stages of the product life cycle... 

Integrated Drug Product Development — From Lead Candidate Selection to Life-Cycle Management... 

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