Modern Pharmaceutical Drug
Analysis essentially involves as a necessary integral component even greater
horizons than the actual prevalent critical analysis of not only the active
pharmaceutical substances but also the secondary pharmaceutical product(s)
i.e., the dosage forms having either single or multi-component formulated
product. The fundamental reasons for this sudden legitimate surge in the newer
evolving methodologies in the ‘analysis of drug substances’ are perhaps due to the
tremendous growth in the progress of ‘medicinal chemistry’ towards achieving
one ultimate objective which is to obtain ‘better drugs for a better world’.
With the advent of
computer-aided-drug modeling (CADM) the critical, scientific and faster approach
to newer drug entities based on the biologically active prototypes,
combinatorial chemistry, chiral chemistry and biotechnology has paved the way
towards more specific, potent and above all less toxic ‘drugs’ to improve the
ultimate quality of life in humans.
Keeping in view the above
astronomical growth in the design of complicated, specific and highly active
drug molecules an equally viable, rigorous, accurate and precise analytical
methods have been evolved with the passage of time which have now occupied
pivotal and vital positions in most of the Official Compendia viz., USP, BP,
Int.P., Eur. P, IP etc., for the analysis of such compounds both in pure and
dosage forms.
The articulated developments in
the fields of science and technology being utilized as on date, amalgamated
with relatively stringent new regulations, namely: Federal Drug Authority
(FDA); International Conference on Harmonization (ICH); Current Good
Manufacturing Practices (cGMP); Pre-Approval Inspections (PAIs) and the like
are now serving as a ‘legal binding’ specifically for the pharmaceutical drug
analysis even much more complicated in comparison to the situation prevailing almost
two decades ago.
The present revised textbook on
‘Pharmaceutical Drug Analysis’ caters for the much needed handbook and
reference book, which is absolutely current with regard to the esteemed
philosophy of analytical chemistry, an obvious solid support towards drug
discovery, development, stability studies, bioavailability and pharmacokinetic
studies, and above all the quality assurance of pure drugs together with their
respective dosage forms.
The thirty-two different chapters
meticulously divided into six parts invariably covers up analytical techniques
being used in most of the Official Compendia. Each chapter categorically and
explicitly deals with the introduction, theoretical aspect(s), instrumentation,
typical examples of pharmaceutical analysis and cognate assays.
The textbook on ‘Pharmaceutical
Drug Analysis’ would enormously serve the undergraduates, postgraduates,
researchers, analytical chemists working in the Quality Assurance Laboratories,
new drug development, production and control, teaching, or regulatory
authorities.
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