How Can Bioanalysis Accelerate Drug Development

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How Can Bioanalysis Accelerate Drug Development
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• The drug discovery and development is a crucial
  project that can take up to 10 years for market
  release and approximately USD 1 billion for
  completion. The process involves generating
  various drug candidates and assessing all the
  underlying properties of these compound so that
  one NCE (Novel Chemical Entity) can be developed.
  The NCE is considered safe for administration by
  the humans for the treatment of intended disease
  or illness. Bioanalysis plays a major role during
  these processes of drug discovery and
  development.
• Understanding Bioanalysis
• Bioanalysis is a process of measuring the
  presence of metabolites in the given biological
  fluid such as plasma, blood, serum, urine, etc. A
  bioanalytical lab conducts two major activities
  during the study of bioanalysis. These activities
  include sample preparation and compound
  detection.

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• The sample prepared for bioanalytics is achieved
  to test the presence of the bioanalytical drug in
  the bioanalytical fluids of the human body. The
  proteins are removed from the sample through
  processes such as solid phase extraction,
  liquid-liquid extraction, and protein
  precipitation.For compound detection, various
  methods are utilized by a bioanalytical lab such
  as high-performance liquid chromatography-tandem
  mass spectrometry (HPLC-MS/MS), atmospheric
  pressure chemical ionization (APCI),
  ultra-high-pressure liquid chromatography (UPLC),
  etc.
• Validation Parameters
• For quantitative procedures included in
  bioanalysis, assessment of the validation
  parameters is imperative to prove the
  selectivity, accuracy, specificity, and precision
  of the method.

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• Selectivity The selectivity indicates the
  ability of the method to develop a response
  related to the target analyte such that this
  response is distinct from other responses.
• Accuracy Accuracy is an indicator of the
  closeness of the outcome as obtained by the
  bioanalytical method in comparison to the actual
  value or concentration of the method.
• Precision The precision of the method is
  obtained by using the method for different
  aliquots and the homogeneous volume of the
• sample that produces close results.
• The repeatability of the method is the closeness
  in results obtained when the bioanalytical
  process is carried out multiple times in the same
  environment on a single day.

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• The intermediate precision of the method is the
  closeness in results obtained when the
  bioanalytical process is carried out multiple
  times in one lab but with different instruments
  and environment.
• The reproducibility of the method is the
  closeness in results obtained when the
  bioanalytical method is carried out in different
  labs on different days.
• Detection Limit The lowest analyte concentration
  found in a sample is the detection limit if this
  limit can be detected but if quantitation is not
  possible.
• Quantitation Limit The lowest analyte
  concentration found in a sample is the
  quantitation limit if this limit can be detected
  and quantitated with precision and accuracy.

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• Robustness It is the measure of the ability of
  the sample to remain unchanged under the
  influence of small changes in the parameters.
• Stability The stability checks the degradation
  ability of the sample analytes during the
  processing, preparing, and storing of the sample.
• Understanding all the validation parameters of
  bioanalysis corresponding to a pharmaceutical
  sample allows the acceleration of drug
  development. These parameters helpscientists to
  avoid unnecessary errors in the procedures in the
  later stages of drug discovery and development.

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• Thanks