1. In Dry powder inhalation Andersen casacde impacor for FPF performing in that we adjusting 60LPM/MIN and time 4second, why? Explain?

As per USP guideline the normal healthy person is having
Lungs Air volume Capacity is 4lit. and when we measure the
air flow at that litre,so flow metre will show the air flow
thus it mean 1 second per 1 Litre, so for the 4 litre is
required 4 second , that's why we performed the Andeson
Cascade at 60LPM/MIN and at 4 second

2. What is the Ph of blood?

The normal pH of blood running through arteries that carry
blood from the heart to other parts of the body) is 7.4;
the pH of blood in the veins (vessels that transports blood
to the heart) is about 7.35

3. What is streptococcus and what is the best drug for it?

Spherical Gram-positive bacteria occurring in pairs or chains; cause e.g. scarlet fever and tonsillitis drugs; penicillin, amoxilin, cephlosporins.

4. What the procedure followed in pharmacokinetic study of drug in plasma?

Pharmacokinetic studies of a drug in plasma were conducted by noncompartmental analysis,compartmental analysis,bioanalytical method and by mass spectroscopy.

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)?

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).

6. What is eCTD? Difference between CTD & eCTD? How it will be prepared? Need of any Software?

The guidance on marketing applications for drugs and
biologics, known as the Common Technical Document (CTD), was
finalized by the International Conference on Harmonization
(ICH) in 2003. Today the CTD format is mandatory for
paper-based marketing applications in Europe, Japan, Canada,
and other regions, and is highly recommended by FDA.

The eCTD format has become mandatory in key regions for
electronic submissions. Since January 2010, the European
Medicines Agency has required all applications in the
centralized procedure use the eCTD format. Since January
2008 FDA CDER has required all electronic submissions be in
the eCTD format. FDA CBER requires the eCTD format for
priority review and rolling submissions.

7. What is the definition of Pka?

It is an equilibrium constant, Used for the dissociation of
a weak acid. it is also known as acid ionisation constant

8. What is the major definition and difference between uniformity of content and content uniformity as official test for all tablets?

uniformity of content(dosage unit):is by two method by
weight variation and by content uniformity.wt variation
means performing assay annd relating with indiviual unit
weight of dosage form.and content uniformity means for ten
sample (dosage unit) individually analysed

9. Explain difference b/w sonication and homozinization?

Homogenization is intensive blending of mutually related
substances or groups of mutually related substances to form
a constant of different insoluble phases (sometimes with
addition of surfactants) to obtain a suspension or emulsion.

Sonication is the act of applying sound (usually
ultrasound) energy to agitate particles in a sample, for
various purposes.


in stability indicating we do the stress testing by
applying different condition so that it can be suitable for
stability testing in stability study till completion

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