Scientific Design

Bugg, Charles E. Carson, William M. and Montgomery, John A. (1993). Drags by Design. Scientific American 269(6) 92-98. 

The statistician s work is crucial both to the justification of the studies proposed for all phases of IND research and to the related study designs. Scientific determination of the necessary size of the initial patient population (phase 2) must depend largely on a statistical estimate of the smallest number that would be sufficient, because the fewer people exposed to the risk of a new drug product, the better. Both risk and cost are reduced. 

Established excipients pose some issues for regulatory consideration. Such issues include the use of a well known excipient by an unapproved route, for example, inhalation of a material that has been used in oral formulations. In these cases, some preliminary toxicity studies may be necessary. Additionally, a well designed scientific review of safety data on the excipient will be necessary, with old findings fully evaluated. 

Cover images copyright 1999 by Obi-Tabot Tabe. The images used on the cover and spine are taken from a 9 4-1/2 oil painting by Obi-Tabot Tabe, PharmD, a painter, graphic designer, scientific illustrator, and pharmacist. 

Figure 2-13. Purifier 10 zone refiner mechanism. (Courtesy - Design Scientific, Inc., Gainesville, GA)...

We need to increase our efforts to keep people released from prison to be able to avoid further criminal activity. Well-designed scientific studies based on molecular imaging with fMRI, PET/CT, and SPECT/CT can be designed to try to understand what happens in the brain during specific desirable and undesirable activities. 

Typeset Cover Design Scientific Publishing Services Pvt. Ltd., Chennai, India. 

Follow-on of chief designers, scientific leaders of projects, and general designers at all the stages of nuclear facility operation. 

These are the consortia of designer, scientific advisor and industrial firms with a history of cooperation that are offering the plant, using the existing infrastructure. 

Considerable experience has now been gathered with submission of applications for biopharmaceuticals. Critical review of this experience has been the basis for development of this guidance that is intended to provide general principles for designing scientifically acceptable preclinical safety evaluation programs. 

Plastic fly bottles ICRF design Scientific Laboratory Supplies LabScientific Inc. 

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