Fundamentals of Medicinal Chemistry

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11 Drug Development and Production 11.1 Introduction Development is the conversion of a biologically active compound into a safe ...

Drug synthesis Acute and subacute toxicology Preclinical trials Phase I trials Submit MAA report Phase II trials Regulatory auth ...

use of large scale equipment (see section 11.2.1). These changes, waste disposal and the hazards associated with carrying out th ...

suitable pipework to other pieces of specialized plant such as filtration, crystal- lization and drying equipment. A variety of ...

the reactions. The heat generated by a large scale reaction may exceed the cooling capacity of the existing equipment with disas ...

necessary to devise appropriate chemical quantitative and qualitative protocols for all of the compounds involved in the pilot a ...

compounds that can act as antagonists for thromboxane (Figure 11.3(b) ). It was found that significant antagonist activity is ob ...

ozonolysis, which is very expensive and needs specialized equipment, and sodium ethanethiolate, which would need special contain ...

used to form the dioxan ring. Finally, where appropriate, the use of sodium ethanethiolate to remove the methyl protecting group ...

The use of animals in drug testing is the subject of considerable debate in the pharmaceutical industry as well as by the genera ...

volunteers undergo an exhaustive medical examination before the tests and are strictly monitored at all times during the trial. ...

The interpretation of the results of all trials requires the close collaboration of clinicians and statisticians. Reliable resul ...

11.5 Formulation development The form in which a drug is administered to patients is known as itsdosage form. Dosage forms can b ...

particular drug, it is essential that the equipment used is cleaned and tested for adulterants before use. Many pharmaceutical m ...

third parties from manufacturing and selling the product without the consent of the innovator. However, patents do encourage and ...

as to the method of production, efficacy, safety and quality of the product. To obtain a product licence the pharmaceutical comp ...

Appendix A.1 Sickle-cell anaemia Sickle-cell anaemia is caused by a defective gene. This gene results in the replacement of the ...

A.2 Bacteria Bacteria are microscopic plants varying in size from about 0.1 to 20. They are usually unicellular and have a vari ...

O O CH 2 OH H NHCOCH 3 H H CH 2 OH H O O NH H NHCOCH 3 H H H O CO CH 3 HC O CH CH 3 COO− CONHCHCH 2 CH 2 CONHCHCONHCHCOO− (CH 2 ...