Principles and Practice of Pharmaceutical Medicine

could, therefore, be at the front end – during the trial planning – rather than the back end – at the analysis phase. The study ...

data obtained from a number of different studies. A new drug application usually consists of many different studies. The approva ...

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26 Data Management T.Y. LeeandMichael Minor Pharmaceutical research and development is a lengthy (8–12 years) and costly process ...

significant ranges, timelines, QC rules, QA sampling, error analysis, criteria to release the database, disaster recovery plan a ...

CRFs COLLECTED BY CRAs LOG-IN TRANSMITTALS PREPARE SCAN VERIFY SCANNING INDEX INDEX QUALITY CONTROL INDEX ISSUE RESOLUTION EDIT ...

CRFs cover sheet (Table 26.4) Preliminary edit check document (Table 26.5) Data query sheet (Table 26.6) Data processing sta ...

the ‘accuracy’, ‘completeness’ and ‘consistency’ of the data within a subject and across subjects. This review and timely comput ...

Are randomization numbers allocated sequen- tially? Are blanks are properly answered? Check adverse events and prematurely disc ...

Manual code the ‘no-hit’ terms and update the glossary. Run computer edit checks (Table 26.5) and gen- erate queries. Reconcil ...

Study xxxx Patient validity decision tree Did the patient receive at least one dose of study drug? Did the patient meet all incl ...

Did not take prohibited drug(s) between visit 1 and visit 3? Had no Group A streptococci, mycobacteria observed post-therapy? Wa ...

who tends to make most of the mistakes. Is CDC review adequate? Are the programs written for the computer edit checks sufficient ...

27 Patient Compliance: Pharmionics, a New Discipline Jean-Michel Me ́try 27.1 Summary Patient noncompliance with prescribed drug ...

Subjective methods usually used to assess patient compliance in drug trials or medical prac- tice grossly overestimate patient c ...

most drugs are eliminated from the body with plasma half-lives of 12 h or less (Feely et al., 1987; Pullaret al., 1991), such th ...

tablets, which are confounded by the high incidence tablet-dumping by poorly/partially com- pliant patients, are documented in v ...

studies is thus not necessarily the same across the different dose groups. This self-selection of drug exposure by the patients ...

It will provide a much more robust basis than presently possible for simulations of phase III clinical trials, because they wil ...

prescribed therapy, and, if necessary, adjust for variable exposure to the test drug. Phase IV More robust outcomes studies beca ...