Drug development phase

Preclinical drug development involves understanding of dosage, formulation, and route of administration, typically in animal models, so that safe and effective doses for human administration can be estimated. The drug development phase extends from prechnical assessment through clinical testing. 

Late Stage Clinical Drug Development—Phase Three... 

All of the above should ultimately result in applying the Teaming and confirming paradigm as laid out by Lewis Sheiner as the basis of drug development, where in the early phases of drug development (Phases I and Ha) the focus lies on learning... 

During early phases of drug development (phase I and II studies)... 

DURING EARLY PHASES OF DRUG DEVELOPMENT (PHASE I AND II STUDIES)... 

A. Stability Testing During Drug Development—Phases I, I and III... 

Parallel group trials (Figure 31.1) are the most popular design and are implemented in all stages of drug development (Phase 1 to Phase 3). Many parallel group trial... 

Table 1 Bulk Drug Demands of the Various Drug Development Phases... 

Abstract This chapter addresses the principles of stability studies in the drug development process. It gives an overview of different types of stability studies that support the entire drug development phases. It also discusses the purpose that one wants to achieve with the data set that these studies generate. 

Introduction Table 1.1 Purpose of drug development phases 3... 

As mentioned above, many other examples of development of analytical methods, fit for purpose in either the drug discovery or drug development phases, conld have been chosen. Some of these are discussed in earlier chapters in the context of general principles of trace quantitative analysis. 

Product holdup (product staying inside the machine after granulation) is of importance during the drug development phase as it limits the minimum batch size possible. The larger the batch size the less important is the product holdup of the machine as it is a constant value independent of the total batch size. Nevertheless, a low product holdup helps in reducing waste and thus helps in cleaning. 

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