山东中医药大学
- As in the case for small molecules, some toxicological studies have to be performed before first use in humans. （ ）
- A drug with wide therapeutic window is often safer than those with narrow ones. （ ）
- Gas chromatography/mass spectrometry (GC/MS) is a highly selective technique. （ ）
- 90%to95%of plants on this planet have not been investigated so far. （ ）
- In a parallel synthesis, each compound remains in its own container, while in a split and-mix synthesis, the related compounds are mixed up in the same reaction vessel. （ ）
- For the drugs that received the FDA, s approval more than 5 years before the final ruling in June 2006, the pharmaceutical companies may elect either to continue the old format of the package insert or to reformat it. （ ）
- The FD&C Act stipulates that the article different in strength, quality, or purity may still have the same name if the difference is stated on the article’s label. （ ）
- USP- NF is continuously revised, Revisions are presented annually, in twice-yearly Supplements, in IRAs, and in Revision Bulletins on the USP website.（ ）
- GMP compliance is a requirement only for the manufacture of drug products. （ ）
- Generation of ATP from ADP is an energy-liberating process. （ ）
- Impurities in the final API will be removed because it will influence the quality of drug products. （ ）
- As far as the function of the package insert is concerned, the FDA finds that it is usually time-intensive and clinically inefficient for many practitioners to get the information they need, because the package insert format disproportionately stressed the occurrence of extremely rare clinical events. （ ）
- Natural products have been a source of drugs and drug leads. （ ）
- The right atrial pumps deoxygenated blood o e lungs where if absorbs oxygen from the air. （ ）
- Bioavailability of a drug indicates whether a therapeutically effective concentration is achieved at the site(s) of action of that drug. （ ）
- Each stage of A PI production will influence the quality of final API. （ ）
- ICH Q7 A is a worldwide guidance for the manufacture of drug products for both commercial and R&D purposes. （ ）
- The existence of microorganisms was observed and discovered in earth. water. air and fire as early as the 6th century BC. （ ）
- Why did FDA decide to reformat drug insert in the 1980s? ( )
- A drug product in the U. S. market must conform to the standards in ( ) to avoid possible charges of adulteration and misbranding.
- Which of the following is not appropriate for the interpretation of the word "current"? ( )
- Which of the following descriptions about the characteristics of nervous regulation is wrong? ( )
- Which of the following statements is TRUE? ( )
- The monomeric subunits of macromolecules ( ).
- Compounded medications gain their popularity due to ( ).
- What category does paclitaxel belong to? ( )
- In a parallel synthesis, all the products are ( ) separately in their own reaction vessels.
- Which of the following is not the characteristic of cells? ( )
- How to understand the sentence "A living organism appears to be more than the sum of its inanimate parts”? ( )
- Which of the following statements is true according to the passage? ( )
- Which of the following parts of knowledge of drugs should be included in pharmacology? （ ）
- Some information in FPI Contents section is cross-referenced in ( ) section.
- Biopharmaceutics mainly studies the in vivo process of drugs and metabolites in humans, animals and tissue culture, which specifically involves ( )
- Formulation is about the design, development and evaluation of dosage forms, ( )
- Which of the following is what a clinician is primarily interested in according to the text? ( )
- Which of the following statements is true according to the passage? ( )
- GMP compliance is a requirement for the manufacture of ( )
- Why is pharmaceutical microbiology regarded as the part of industrial microbiology? ( )
- ( ) is often referred to all therapeutic, prophylactic, and in vivo diagnostic agents produced using live organisms or their functional components.
- Which of the following descriptions about the control of body function is wrong? ( )
- Doped compounds are identified using the highly selective combination of gas ( )-mass spectrometry (GC-MS).
- In glycosidic linkage hydrolysis, which of the following is the easiest in different glycosidic atoms？ ( )
- Small molecules generally need a PK assay for ( ) of the unchanged compound and its (major) metabolite(s).
- ( ) should be used to judge efficacy and effectiveness.
A:错 B:对
答案:错
A:对 B:错
答案:对
A:对 B:错
答案:错
A:对 B:错
答案:对
A:对 B:错
答案:对
A:错 B:对
答案:对
A:错 B:对
答案:对
A:对 B:错
答案:A: 对
A:错 B:对
答案:错
A:对 B:错
A:错 B:对
A:错 B:对
A:错 B:对
A:错 B:对
A:对 B:错
A:错 B:对
A:错 B:对
A:对 B:错
A:Because the information the health professional need in drug insert is not accessible. B:Boxed warning was not included in the drug insert. C:None of the above. D:The occurrence of rare clinical events is not proportionately included in the drug insert.
A:United States Pharmacopoeia B:International Pharmacopoeia C:National Formulary D:USP-NF
A:keeping current with the best practice of pharmaceutical industry B:keeping current with the interpretations of the regulations C:keeping current with FDA'S expectations D:keeping current with the requirements of patients
A:It acts exactly. B:It responds fast. C:It responds slowly. D:Duration is short.
A:A drug that is proved effective in a clinical trial will have similar effectiveness in actual use. B:A drug will certainly be efficacious in actual use if it was already proved in clinical trials. C:Drugs that are efficacious in clinical trials may not be very effective in clinical uses. D:A drug that is efficacious in clinical trials will always be not very effective in actual use.
A:have a molecular weight (MW) larger than about 500 B:belong to 20 different types C:can be non-covalently linked in a virtually limitless variety of sequences D:are constructed to serve various functions in living cells
A:their greater extend of advertising power B:their much lowered price C:all of the above D:their ability to individualize patient medications
A:antineoplastic agents B:antibiotics of aminoglycosides C:lipid regulating agents D:Analgesics
A:combined B:Assorted C:joined D:assembled
A:They possess a nucleus which contains genetic information in the form of deoxyribonucleic acid (DNA). B:They are bound by the plasma membrane C:They have the ability to break down large molecules to smaller ones to liberate energy for their activities. D:Living cells can not transform materials
A:There are more inanimate parts than living organisms. B:A living organisms is in a larger size than the sum of its inanimate parts C:The number of living organisms is larger than that of inanimate parts D:A living organism is not only the accumulation of its inanimate parts
A:Boxed warning can help health practitioners distinguish critical information from less important information. B:The drug insert is compiled and distributed by drug manufacturers, providing detailed drug information to health practitioners. C:The first drug Insert appeared in 1968, with the two lines of warning laced in the isoproterenol inhaler package D:Since a separated drug insert is required by the FDA, the drug insert has become more lengthy and detailed.
A:The effects of drugs on man B:The prevention, recognition, and treatment of drug poisonings. C:The correlation of biological activity with chemical structure D:The history, source, physical and chemical properties, compounding, biochemical and physiological effects, mechanisms of action, absorption, distribution, biotransformation and excretion.
A:Black Box Warning B:Warnings and Precautions C:Contraindications D:Highlights of Prescribing Information
A:absorption and excretion B:absorption, distribution, metabolism, and excretion C:absorption and distribution D:metabolism and excretion
A:analytical methods B:dosing regimen C:drug delivery systems and manufacturing process D:discovery of novel drugs
A:Drugs which can be reasonably limited to those aspects that provide the basis for their rational clinical use. B:Drugs which help resolve the continuing abuse of drug. C:Chemical agents that are not used in therapy but are commonly responsible for household and industrial poisoning as well as environmental pollution. D:Drugs which are useful in the prevention, diagnosis and treatment of human disease, or in the prevention of pregnancy.
A:Some prescribers find that Black Box Warning can help them to avoid the risk of being accused. B:Warning information can be put in either Black Box Warning section or Highlights of Prescribing Information section. C:The information in Black Box Warning is the most important in a drug insert. D:The Highlights of Prescribing Information section contains the most prominent risk and warning information in detail.
A:investigational medicinal products B:drug products C:APIs D:all of the above
A:Microorganisms are used in degradation of industrial wastes B:Microorganisms are used in diagnostic assays C:Microorganisms are used in the production of medications D:Microorganisms are used in the clinical laboratory
A:Biopharmaceutics B:Pharmaceutics C:Pharmaceutical D:Biopharmaceutical
A:Negative feedback minimizes the changes, leading to stability. B:Feed-forward makes human body foresee and adapt itself to the environment promptly. C:Homeostasis is kept by feedback control D:Positive feedback is not useful
A:flow B:phase C:Chromatography D:concentration
A:N B:S C:alcohol glycoside D:phenol glycosides
A:Characterization B:qualitation C:evaluation D:quantification
A:Intermediate outcomes B:Surrogate and intermediate outcomes C:Surrogate outcomes D:Patient-oriented outcomes
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