Research and development (R&D)

mass balance, synthesis, reaction, how to do development

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How to do development

  • How it is absorbed, distributed, metabolized, and excreted.

  • Its potential benefits and mechanisms of action.

  • The best dosage.

  • The best way to give the drug (such as by mouth or injection).

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Mass balance

, the number that should be reconciled with the potency of the drug to determine mass balance is (0.5% X [Mp ÷ MD]). That is, if the loss in potency as determined from the assay is equal to (0.5% X [Mp ÷ MD]), then there is perfect mass balance

Reaction

Name Reaction and other reaction covered

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There are mainly five types of organic reactions:

  • Substitution reaction.
  • Elimination reaction.
  • Addition reaction.
  • Radical reactions.
  • Oxidation-Reduction Reactions.

Curriculum

Discovery and Development.

New insights into a disease process that allow researchers to design a product to stop or reverse the effects of the disease.

Preclinical Research

Before testing a drug in people, researchers must find out whether it has the potential to cause serious harm, also called toxicity. The two types of preclinical research are:

In Vitro , In Vivo

 

FDA Drug Review

If a drug developer has evidence from its early tests and preclinical and clinical research that a drug is safe and effective for its intended use, the company can file an application to market the drug. The FDA review team thoroughly examines all submitted data on the drug and makes a decision to approve or not to approve it.

FDA Post-Market Drug Safety Monitoring.

Even though clinical trials provide important information on a drug’s efficacy and safety, it is impossible to have complete information about the safety of a drug at the time of approval.

Gatterman Reaction

Chlorine or bromine can be introduced in the benzene ring by treating the benzene diazonium salt solution with
corresponding halogen acid in the presence of copper powder. This is referred as Gatterman reaction.

Balz-Schiemann Reaction

When arenediazonium chloride is treated with fluoroboric acid, arene diazonium fluoroborate is precipitated
which on heating decomposes to yield aryl fluoride

Finkelstein Reaction

Alkyl iodides are often prepared by the reaction of alkyl chlorides/ bromides with NaI in dry acetone. This
reaction is known as Finkelstein reaction

Swarts Reaction

Heating an alkyl chloride/bromide in the presence of a metallic fluoride such as AgF, Hg2F2, CoF2 or SbF3 gives
alkyl fluorides. The reaction is termed as Swarts reaction.

Wurtz Reaction

Alkyl halides react with sodium in dry ether to give hydrocarbons containing double the number of carbon atoms
present in the halide. This reaction is known as Wurtz reaction.

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