Principles and Practice of Pharmaceutical Medicine

example several reports coming from the same doctor or practice (is the so-called hepatotoxi- city really a local outbreak of vi ...

literature on the difficulties that are encountered in getting doctors to observe new contraindica- tions is very extensive and ...

References Committee on Safety of Drugs. 1971.Report for 1969 and 1970. HMSO: London. Mackay, The Honourable Mr Justice. 2002. I ...

SECTION VII Legal and Ethical Aspects of Pharmaceutical Medicine Introduction Ethical conduct in both drug development and ordin ...

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45 Introduction to Bioethics for Pharmaceutical Professionals Andrew J. Fletcher 45.1 Introduction Discourse on ethics dates bac ...

Self or small-group interest versus community or large-group interest Short-term interest versus long-term interest Loyalty v ...

Inductive reasoning Inductive reasoning is the process ofconcluding that a general principle is true because the special cases y ...

standard. Again, this is principally a deductive approach, and not very far from Kant’s categorical imperatives. Objectivism ver ...

Informed consent As the term implies, subjects must be fully informed about the nature of the experiment, the known benefits and ...

‘All Animals Are Equal’ (Peter Singer)^15 Kant argues that we do not have a direct duty to animals, and, therefore, killing the ...

not been obtained and that families were not told that an alternative and effective nonexperimental antibiotic, chloramphenicol, ...

It is true that in the hospital environment, such committees’ activities may have greater scope than a clinical trial IRB. Rober ...

46 Pharmaceutical Medicine and the Law Sarah CroftandTimothy Pratt 46.1 Introduction In this chapter, we introduce basic legal p ...

46.3 Criminal and civil law distinguished Generally speaking, law is broken down into two separate components – criminal law and ...

the contract have obligations and gain rights under the agreement. The law of contract regulates the enforceability of such agre ...

In order to succeed in a claim of negligence, a plaintiff must prove all three elements. It is not enough to show that the defen ...

regulatory bodies to carry out the functions out- lined in it, including the following: (a) The Licensing Authority, which decid ...

(FDA) is the primary regulatory agency and the Food Drug and Cosmetic Act (FDCA) is the principal statute governing pharmaceutic ...

with the 1998 Act. It should be noted that breach of the Act could result in criminal penalties. In the United States, federal l ...