Explain Three Things That An Ideal Parenteral Dosage

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1) What are the two main factors that effect the rate and absorption of an orally administered drug?
With regards to making an orally administered drug, permeability and solubility are two key factors that affect the rate and absorption that is accomplished in the body. Permeability of a compound, is the process accomplished in the GI tract by absorption, usually in a specific segment or when exposed to certain active transporters. Solubility on the other hand, controls the rate that the drug is absorbed and control this by the different characteristics of the compound like salts, polymorphs, smaller particles and the pH.
2) What is the pH in the stomach and what is it in the small intestine?
The pH plays a profound roll in solubility of certain
IR and ER dosage are different in the idea in how these compounds are released, one being Immediate Release and the other being Extended Release. Through the systemic circulation IR dosage is controlled by the rate of action through the metabolism and elimination. However, ER dosage is dealing with the rate within the pharmacokinetics so that this influence could have a prolong effect for the individual.
4) Name three things that an ideal parenteral dosage form must be?
There are three things that an ideal parenteral dosage must be sterile, o-toxin free and particulate free products. Due to parenteral drug delivery being administered in a way that bypasses many of the bodies usual defense mechanisms, these things are essential to having an ideal parenteral dosage.
5) What do the abreviations ADME stand for?
The abbreviation, ADME stands for absorption, distribution, metabolism, and excretion. This is specifically used in the evaluation of pharmacokinetics within a particular compound to assess its safety and efficacy to be used eventually towards humans.
6) Provide three properties of an ideal drug
NOAEL on the other hand is more favorable and used, it stands for No Observed Adverse Effect Level. With the application of the highest exposure level in these testing’s, there evaluated on not just the basis of producing no adverse effects but there being no potential for an adverse event.
8) What are the three standard tests used to determine mutagens?
The three standard test used to determine mutagens include; Bacterial Mutation Assay (AMES Test), Chromosome Aberration Assay, and Mouse Lymphoma Cell Mutation Assay. These studies are to ensure that the compound has not altered the coding sequence of the DNA in any way from its original sequence. Specifically, using organisms used to asses this observation of safety within the developed drug.
9) Describe the form FDA 1571 and what is it used for?
The FDA 1571 form is the Investigational New Drug (IND) application, that is to be submitted at the end of the preclinical evaluation. This is a detailed form of the necessary information which the FDA will review and give their decision on the drug and if its adequate to be implemented on humans. This form is used as the sponsors aid to show evidence and information regarding the compounds ability to safely and effectively be administer in regards to a certain

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