Principles and Practice of Pharmaceutical Medicine
...
6 Nonclinical Toxicology Frederick Reno Testing new pharmaceutical agents for tolerability in nonclinical studies is a critical ...
(GLP;Federal Register, December 1978; also see Williams and Hottendorf, 1997). These define technical matters such as laboratory ...
6.5 Initial nonclinical considerations Formulation Aspects It is desirable to carry out pivotal nonclinical studies using the pr ...
(and possible major metabolites) in solvents and plasma. Such assays need to be separately vali- dated for each nonclinical spec ...
Acute toxicity studies Single-dose studies in animals are an important first step in establishing a safety profile, with the gen ...
administration should be the same as that planned in humans, whereas the animal studies should involve higher doses and longer d ...
today that have produced some type of positive response in these studies, and yet it has been concluded that no human risk is pr ...
studies are required. Table 6.3 lists the guidelines from major countries. As can be seen from these guidelines, it is not alway ...
Chronic toxicity studies As discussed above, the extent of additional repeated-dose studies are generally outlined in Tables 6.2 ...
structure–activity similarities to known carcino- gens, evidence of preneoplastic lesions in repeated-dose nonclinical studies, ...
well-written integrated summary can be beneficial not only to the agency reviewer but also to the sponsor. Some of the informati ...
...
7 Informed Consent Anthony W. Fox 7.1 Introduction There is a tendency to assume that the principles of informed consent are sel ...
7.3 Written informed consent The large majority of clinical trials use a written informed consent document. In the absence of an ...
Ethics committees and IRBs may sanction specific methods for the documentation of oral informed consent. This is a very rare cli ...
document is essentially an agreement between ethics committee, investigator and patient. How- ever, for example, an investigator ...
8 Phase I: The First Opportunity for Extrapolation From Animal Data to Human Exposure Stephen H. Curry, Dennis McCarthy, Helen H ...
trend for more efficient use of resources in early clinical development. 8.1 The in vitro/in vivo prediction The challenge is to ...
concentrations that the elimination mechanism becomes unsaturated, and first-order elimination then supervenes; good examples in ...
«
1
2
3
4
5
6
7
8
9
10
»
Free download pdf