Development decisions

An ElA can be particularly useful in distinguishing the relative environmental impact of alternative sites, processes and strategies for industrial, rural or urban development. Decision-makers to choose the alternative that will provide maximum economic and social benefits with the minimum of environmental disturbance can then use this essential environmental information, together with financial and political considerations. Guidelines for assessing... 

Inspection and tolerance Inspection variations are often the most critical and most overlooked aspect of the tolerance of a fabricated product. Designers and processors base their development decisions on inspection readings, but they rarely determine the tolerances associated with these readings. The inspection variations may themselves be greater than the tolerances for the characteristics being measured, but without having a study of the inspection method capability this can go unnoticed. 

COMPUTERS IN DEVELOPMENT DECISION MAKING, ECONOMICS, AND MARKET ANALYSIS... 

Cluster analysis is a quantitative form of classification. It serves to help develop decision rules and then use these rules to assign a heterogeneous collection of... 

ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT, Decision of the Council of the OECD of 12 Mar 1981 Concerning the Mutual Acceptance of Data in the Assessment of Chemicals, Paris, OECD, 1981. 

DiMasi JA, Caglarcan E, Wood-Armany M. Emerging role of pharmcoeconomics in the research and development decision making process. PharmacoEconomics 2001 19 753-66. 

Sometimes the terms early and late clinical development are used instead of the phases 1, 2 and 3. Early development refers to all studies before the full development decision point, whereas late clinical development refers to all studies thereafter. 

Figure 2.10. The microdosing strategy for candidate selection offers the greatest benefit when a stop-development decision is made. This is because the exploratory IND does not forego the submission of a traditional IND to continue testing in the clinic. (IND, Investigational new drug mths, months FIH, First-in-human clinical study Ph1, Phase 1 clinical studies Ph2, Phase 2 clinical studies.)...

Drug Development Need Analysis Activity Data Currency for Drug Development Decision... 

PANELIST HILL I agree. There is a real problem in trying to make these predictions. In the natural gas area it is particularly difficult because of the situation that has existed for such a long period of time wherein the Federal Power Commission was holding the wellhead price of natural gas at an extremely low and artificial price. The Federal Power Commission, in setting that price, considered only proven reserves of natural gas. In turn, proven reserves are defined as resources that can be produced at prevailing prices. A company would look at a new natural gas development decision on the basis of what gas they could get at prevailing wellhead prices and make a profit. 

Biologies often require significantly different timing for key development decisions to facilitate clinical development and manage risk. 

All of the above information will prove invaluable in determining the potential methods for rational drug delivery. Particular attention should be paid to the relative hygroscopicity of the API, of course, any stability information, as well as the impurity profile and ADMET (absorption, distribution, metabolism, excretion, and toxicity) information. In short, the more information that is available when development activities are initiated, the easier it is to avoid common pitfalls and make development decisions more rationally. 

Decision to enter preclinical development. Decision on target countries. 

A well-founded decision to enter the development phase of a product usually takes several months. Often delays occur, because the decision was not anticipated and the necessary facts, figures and reports were not collected in advance. If the decision making individuals are not prepared and do not indicate early enough what kind of information and prerequisites they need to make the decision, months could be lost. For example, the existence of an acceptable product profile (compare Table 2) including the required information and evaluations may be used as a basis for a development decision. 

Analysts study companies pipelines and calculate the probabilities of successful clinical trials in preparing advice on their own investments. Investors tend to have a much shorter-term view than industiy managers and scientists can afford to have. The influence of investors on drug development decisions should not be underestimated, and the influence is not always positive. 

For those who desigii/ track/ and make decisions regarding the progress of clinical development programs/ the inclusion within the development plan of critical decision pointS/ with prespecified go/no-go criteria/ provides a focus for the clinical development team. The key clinical drug development decisions are identified in Table 33.2/ with the critical go/no-go decisions being shown in boldface. These critical decisions will be expanded on later in this chapter. It is important to note that the driver for these decisions is our question-based label-driven clinical development plan. Indeed/ the creation of a label-driven question-based clinical development plan not only increases the efficiency and speed of the clinical development process/ but also supports the question-based review by the FDA of an NDA/ as described by Lesko and Williams (35). 

CRITICAL CLINICAL DRUG DEVELOPMENT DECISION POINTS... 

Chapter 6 Implementing Sustainable Development Decision-Support Approaches... 

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