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Question - 1:
In Dry powder inhalation Andersen casacde impacor for FPF performing in that we adjusting 60LPM/MIN and time 4second, why? Explain?
ue
Ans:
As per USP guideline the normal healthy person is having
Lungs Air volume Capacity is 4lit. and when we measure the
st
air flow at that litre,so flow metre will show the air flow
60.
thus it mean 1 second per 1 Litre, so for the 4 litre is
required 4 second , that's why we performed the Andeson
io
Question - 2:
What is the Ph of blood?
Ans:
A
Question - 3:
What is streptococcus and what is the best drug for it?
er
Ans:
Spherical Gram-positive bacteria occurring in pairs or chains; cause e.g. scarlet fever and tonsillitis drugs; penicillin, amoxilin, cephlosporins.
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s.
Question - 4:
O
Pharmacokinetic studies of a drug in plasma were conducted by noncompartmental analysis,compartmental analysis,bioanalytical method and by mass spectroscopy.
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G
Question - 5:
What will be in case stability sample Which have batch but distribute in three country. In tath case< we can put the sample for all country, whenevr all have same
temp(Zone)?
Ans:
Stability of sample doesnot depend on material you had sent
in different coutries.you should carry long term stablility
of only one retained sample as per ICH guidelines (temp and
humidity conditions).
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Question - 6:
What is eCTD? Difference between CTD & eCTD? How it will be prepared? Need of any Software?
Ans:
The guidance on marketing applications for drugs and
Question - 7:
What is the definition of Pka?
w
Ans:
It is an equilibrium constant, Used for the dissociation of
a weak acid. it is also known as acid ionisation constant
Q
Question - 8:
ue
What is the major definition and difference between uniformity of content and content uniformity as official test for all tablets?
Ans:
uniformity of content(dosage unit):is by two method by
st
Question - 9:
Explain difference b/w sonication and homozinization?
Ans:
A
Question - 10:
DEFINITION OF STABILITY INDICATING METHOD?
Ans:
s.
Question - 11:
ONLINE TRAINING IN ORACLE CLINICAL 4.6 (Clinical Data Management) and SAS -SDTM mapping?
G
Ans:
KARMEL Biosciences is an international reputed Clinical
Services Organization providing full range of Clinical Data
Management services to global pharma and biotech
Companies.Karmel Bio has concluded agreements with multiple
major hospitals in India and China for ICH- GCP Training of
Investigators and site Monitors. Karmel Bio also conducts
the international conferences and seminars in India and
China.
We are offering online training in Clinical Data Management
and Advanced Clinical SAS
1)Oracle Clinical 4.6 (Clinical Data management) 2)Advanced
Clinical SAS (SDTM mapping) 3)Live project in Clinical Data
Management
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Question - 12:
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