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1. the term "Site Management Organization". How do they differ from "Contract Research Organizations?"
2. What is acceptance number 0?
3. how do we calculate about stability, and disintegration time?
4. Is calculate about stability any more cost for investigation of antibiotic drug?
5. How do we connect with "who"
6. I cannot understand the terms ?chemistry-space metrics generated by the software
7. is the typical CRO specialized on certain clinical trial types, is the specialization a foreseeable trend?
8. Is there a way I can get a "hand-on" practice session with MedDRA, or a MedDRA auto-encoding system.
9. While clinical trails are ongoing are the pre-trials being continued at the same time?
10. Does QSR (Quality System Regulations) already replace GMP Good Manufacture Practices officially?
11. Can we consider that piece of vein as a biological device?
12. Can you provide names of some FDA approved ERP software? Who uses it here in Toronto?
13. Can you shed more light on the patent package adopted by Celgene that offered the drug enough protection and presumably made the production of Thalomid profitable?
14. Is it importance to remember these rules like 21 CFR parts i.e. by their numbers and what they relate to? CFR is the abbreviation for ....?
15. When talking about dose-response what do they mean by: comparisons in terms of blood/tissue levels vs mg/kg basis?
16. Could you explain the term "compendial analytical method"Does it mean express method or qualitative (yes/no) analysis?
17. What is the meaning of the word: con·com·i·tant?
18. What does Concomitant test articles - mean?
19. What does Covered clinical study mean?
20. What is the declaration of Helsinki?
21. What do Quality System , Quality Management, Quality Assurance , Quality control , and Regulatory Affairs mean?
22. Please explain the « double dummy » concept while using a placebo in an active control trial.
23. What is the definition of efficiency?
24. Can we consider a small company manufacturing experimental drugs fortesting as an R&D company?
25. What is HPLC?
26. Could you please explain what is banding effect as a result of cromatide exchange test?
27. When herbs have been proved to cure many common ailments, I feel that there must be some variety of herbs which may even prove beneficial in curing serious diseases like cancer, AIDS etc. Could you throw some light on this?
28. How can you explain, that generally speaking, the price of Canadian drug is 30% to 80% less expensive than its American counterpart?
29. How easy could I find the entry level position after graduationfrom KRC having no medical or bio-tech education?
30. It seems to me that companies need professionals with at least 5 years of Canadian experienceonly and QA management is becoming more emergency service for problembusinesses.
31. It seems to me that companies need professionals with at least 5 years of Canadian experienceonly and QA management is becoming more emergency service for problembusinesses.
32. What does in Vito mean?
33. What are IPR Guidlines?
34. Is the CRO held responsible for any of the adverse events during the trial?
35. I came across the terms ‘ischemic wounds’ . Could you please brief me on the same?
36. Is it possible to get hands on monitoring experience (go to site) as a volunteer?
37. Who are the members of therapeutic product directorate and therapeutic product pannel, of Health Canada? Who is enforcing the drugs and food act?
38. What is the nursing rationale for assessing colour, warmth, movement and sensation.
39. I would like to ask about Ribavirin. As I know, ribavirin inhibits viral m-RNA. Is it possible use Ribavirin as an inhibitor against RNA replication of Dengue virus?
40. I would like to ask about Ribavirin. As I know, ribavirin inhibits viral m-RNA. Is it possible use Ribavirin as an inhibitor against RNA replication of Dengue virus?
41. Please explain phazes I-IV in a clinical trial
42. Can I find text of ISO in the Internet?
43. What does Epidemiological mean?
44. Can you please explain in simple terms what is safety data?
45. What are the differences in the ICH GCP guidelines in conducting clinical trials for medical devices as compared to drugs? Also similar discussion for 'procedures'?
46. What is Modified Hachinski?
47. What is the meaning of SQL programming language?
48. In 50 ㎍/ml, what does the symbol ‘㎍’ stand for?
49. I came across the terms ‘ischemic wounds’ and ‘neodermis’. Could you please brief me on the same?
50. How many CRA we need for 35,000 subject?
51. Regarding the terms Investigational New Drug Application and Investigational New Drug Submission, are both one and the same or is it different in terms of purpose?
52. Is FDA the authorizing committee for drugs only in the US or does it have powers/function in other countries as well?
53. Do all pharmacy companies follow the regulations of a Drug Authorizing Committee before releasing a drug into the market?
54.I have a question regarding the EGF03/CT-032 Project, namely regarding the confidentiality of the projects in general. Is it possible to write a letter to a potential Investigator, without breaching the confidentiality rule?
55. What is the Difference between Adverse Drug Reactions and Adverse Drug Events?
56.Suppose an investigational drug in its Phase I clinical trial shows SeriousAdverse effects, for example, Jaundice in3%,Hypotension in 4%, edema in 5%, respiratory suppression in 10%, coma in1% etc. Can it be suggested for its Phase II clinical trials?
57. What do we exactly mean by Inclusion and exclusion criteria in a protocol?
58. What is SOPs?
59. Is there any provision for other countries to join ICH or is it a closed organisation?
60. Please explain the term ‘exogenous xenobiotic’ and give some examples. Is there any such thing as endogenous xenobiotic?
61. What are negative and positive control groups ?
62. Could you please explain what exactly is Assay Sensitivity and its role in Equivalence trials.I have checked the FAQs but the explanation there is some what same as given in text. It is not explicit.
63. What do you mean when u say data should be 'contemporaneous'?
64. What are biometric-based electronic signatures ?
65. What is a Minimum Data Set or MDS in relation to clinical research?
66. Study Planning Activities?
67. Do you know any links to good web-sites with complete manual on statisticassay?
68. What is NIH policy?
69. "What is 'Noninferiority Trial'?"
70. A non-therapeutic trial (i.e., a trial in which there is no anticipated direct clinical benefit to the subject)Under what circumstances would one do this sort of trial?
71. Compassionate Use Defined
72. I need explanations about "CONCURRENT VALIDATION"
73. Could you please define statistical process control ?
I was searching on the Apotex company site and I didn't understand the following abreviations regarding a Drug Informartion Associate Position in Apotex:
75. Cytotoxic Agents?
76. Definition for Dalton
77. Definitions of Regimen and Comparator
78. What is the difference between local and central IRBs?
79. Does QSR (Quality System Regulations) already replace GMP Good Manufacture Practices officially?
80.How much (in terms of percentage) it would cost to study the efficacy requirement of a drug compared to the safety requirement of the same?
81. Could you please give 1 or 2 examples of non-therapeutic trial highlighting the importance of this type of trial?
82. In a double blinded study,at the end on trial how will we come to know that which group was getting effective treatment and which is getting placebo
83. I do not understand the word assay.
84. Are there ever situations where the treatment or device on trial is so ineffective as to lead to further deterioration in the subjects condition, and what happens in situations like these?
85. Would muscular dystrophy be considered a cachectic and ataxic disorder?
86.I will be thankful if you provide a concrete example of no-treatmentclinical group and its advantages and significance
87. What does include Pharmaceutical Dosage Formulation and Stability Testing ?
88. What does include Pharmaceutical Dosage Formulation and Stability Testing ?
89. What is PK/PD Data ?
90. How would ARs are reported by trial participants AFTER the trial is complete and marketing approval received ?
91.Publication of trial results by investigator: What is the current status of this situation?
92. I am not sure that I understood the corectly definition of BPR.
93. How is Quality of life and Pharmacoeconomics related to clinical trials?
94. Please find below the passage of text where the term "analyte" appears. Please explain this term.
95.What are differences between quality system and quality function?
96. Can the sponsor request changes to the study timelines (i.e. request less time or more time for the study) ?
97. Could you please explain some of the challenges which would be faced by the pharmaceutical companies in the future?
98.Label of investigational drug
99. What are Recrudescence, Quiescent
100.What does " crossover studies " mean?



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