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
This paper discusses pharmacology and terminology related to “Pharmacology” which is the branch of medicine concerned with the uses, effects, and modes of action of drugs“ pharmacology. 2015. In Merriam-Webster.com. The study of different classes of drugs, routes of absorption, and drugs have effects on those consuming them. There are drugs that are necessary for illnesses and healing but, there are medicines that cause concern regarding interaction and harming the body.
Perusing warning letters in FDA’s Electronic Reading Room yields a plethora of violations regarding adulterated, misbranded or falsely claimed benefits of drugs and supplements. These three issues, consequently, constitute stumbling blocks in drug development or approval and additionally, perhaps also indicate a wanton disregard of compliance in manufacturing and marketing. Do the responsible companies prioritize compliant procedures and documentation? Through investigating three of the most commonly cited reasons for FDA 483 letters, applying them to the above violations, and exploring a culture of compliance, some rationale for causes in this case may be determined.
“The Federal Food, Drug and Cosmetic Act (FDCA) establishes standards to prohibit misleading labeling.” (Gresham, 2013) “The FDCA also requires that manufacturers of drugs gain approval from the Food and Drug Administration (FDA) prior to engaging in interstate commerce.” (Gresham, 2013) Any new drug is submitted under a New-Drug Application (NDA) for approval. The Hatch-Waxman Act was created for generic drugs. In addition, under the Hatch-Waxman Act
Overall, I retain three goals for this clinical day: Safely and efficently administer medication, enhance my nursing/CNA skills, and determine how to implement infection control into a health care setting. This week reflects my assigned time to administer medication in a health care setting for the first time, with a resident who retains nearly twenty medications. I except this experience will be a great learning experience, but it will also subsist slightly stressful. With the assistance of my FOR, my goal is to administer all of my resident 's medications without complications. To ensure that medication safety, I will perform the six medication rights and three checks prior to administration. Along with medication administration, a goal
and to issue recommendations for improvements. The committee was composed of 16 experts, including leaders in clinical medicinemedical research, economics, biostatistics, law, public policy, public health, and the allied health professions, as well as current and former executives from the pharmaceutical, hospital, and health insurance industries. The authors found major deficiencies in the current FDA system for ensuring the safety of drugs on the American market. Overall, the authors called for an increase in the regulatory powers, funding, and independence of the FDA. Some of the committee's recommendations have been incorporated into drafts of the PDUFA IV bill, which was signed into law in 2007.
this drug as a "schedule I" drug that means that it has high potential for abuse.
...e enforced. Drug dosing and incorparting proper round the clock methods also help prevent resistance. According to Karch, around the clock dosing helps eliminate the peaks and valleys in drug concentration and helps maintain constant therputic levels.
Before a person is prescribed this pill, the patient is supposed to undergo a complete physical examination, the patients record should be contained with detailed documentation of the nature and intensity of the pain, current and past treatment, other illnesses, and their history of drug and alcohol use.
outlines the benefits and risk reported in the tested population. For a drug to be approved by
Animal models have been the standard for safety testing since the early twentieth century, when rats, mice, and dogs were (and still are) used in both biomedical and cosmetic research. During this time, the United States passed The Food, Drug, and Cosmetic Act requiring pharmaceutical and cosmetic companies to conduct tests on animals to ensure the safety of their products (Evans, 2013). These tests were deemed toxicity tests for their measurement of harmfulness and lethality of new drugs and products. Such tests as the Draize test on rabbits, which measures dermal corrosivity, were common protocol for testing shampoos, pesticides, and household chemical products (Rangantha & Kuppast, 2012). Other tests include acute toxicity tests conducted to determine the effects of immediate chemical exposure, product testing measuring carcinogenicity and birth defects resulting from chemical exposure, and various drug tests which determine lethal side effects and appropriate dosages (Evans, 2013). Though some of these tests have provided important and inferential data regarding the harmfulness of consumer products and drugs, they are highly criticized for their inhumane procedures, costliness, and irre...
Leonard G.S., Tovey G.D., Lee R.M., (1979) The Pharmaceutical Development and Bioavailability of Cimetidine Capsule and Tablet Formulations, DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY, 5 ( 2 ) , pp 217-226.
6- How might the weakness associated with JNJ manifest itself in terms of pharmacokinetics and pharmacology?
Firstly, nurses are expected to practice evidence-based health care hence a mastery of information about the essential and safe dose of drugs for a patient is very important for a nurse. Consequently, it could be the determinant between the life and the death of the patient. Pharmacology is a discipline which is mandatory for the nurse to excel in to be efficient in discharging his/her duties. Understanding which drug to use, the right dosage, the expected side effects which may occur and the contra-indications of the various drugs are key in the preservation of
test whatever it's a bad effect or not. So when it used on humans, we
. Aerosols can avert the first fast metabolism and can also avert inactivation of drugs by enzymatic and PH action of the intestine.