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Re: Fdc4 post# 8254

Friday, 07/02/2021 2:50:47 PM

Friday, July 02, 2021 2:50:47 PM

Post# of 13742
Whether a stock is on the OTC pink, OTCQB or even the NASDAQ, it will take solid catalysts to move the stock price.

Sales of goods or making progress through the FDA IND application process are the biggest catalysts that will launch the stock price.

Quanta POTENTIAL is HUGE and when the right catalysts are achieved it will be reflected in the stock price.

The DNA study I believe will come sooner than later however I have know idea how long the Pharmacokinetic (PK) study will take.



Pharmacokinetics (PK) Study: Drug Concentration vs. Time in the Body



A pharmacokinetic study provides the basis for determining drug exposures in the body over time. PK parameters are used in the evaluation of the absorption, distribution, metabolism, and excretion (ADME) processes of drugs.

Absorption
Absorption, the first topic of PK studies, is the initial process by which drugs enter the blood circulation following dosing. Drug substances in PK lab testing can be administered to the body through several routes such as oral, nasal, dermal, or parenteral. Absorption at the gastrointestinal tract, one of the most common drug absorption sites, is affected by several factors including physicochemical parameters of the drug, gastrointestinal motility, drug concentration, and ionization state at the site of absorption.

Distribution
Distribution is a reversible drug transfer within the body from one location to another. The distribution of a drug can be influenced by several factors such as lipid-solubility, concentration in plasma and various tissues, and protein binding of drugs in plasma and tissues. PK studies assess whether compounds can distribute throughout the body readily or are confined to the bloodstream once absorbed.

Metabolism
Metabolism, an essential topic of PK analysis, is the process by which a drug is converted to another chemical entity (metabolite). Metabolism happens primarily in the liver and is classified into two broad categories: Oxidative metabolism includes hydrolysis, oxidation, and reduction reactions driven mainly by the cytochrome P450s, monooxygenase systems, and alcohol dehydrogenases. The typical chemical reactions involved in oxidative metabolism include aromatic hydroxylation, aliphatic hydroxylation, oxidative N dealkylation, oxidative O-dealkylation, S-oxidation, reduction, methylation, and hydrolysis. Most often, these reactions increase compound polarity to make a drug more soluble, facilitating elimination through the kidneys. In conjugative metabolism, conjugation occurs by glucuronidation, sulfation, amino acid conjugation, acetylation, or glutathione conjugation to aid elimination. Enzymes involved in conjugation include UDP glucoronyl transferases, aryl sulfatases, N-acetyl transferases, and glutathione S-transferases. Conjugation can serve to inactivate a compound or make it more readily eliminated by urinary or biliary excretion. Several factors influence a drug’s rate of metabolism, including the route of administration, dose, genetics, disease state, and metabolic activity.

Excretion
Eliminating the drug and other toxic substances from the body, the last topic of the PK study, is known as the process of excretion. Most drugs in the body are eliminated through the urine. Excretion also depends on the solubility of the drug in water. More soluble drugs are excreted faster in the urine. If the excretion is incomplete, the accumulation of compounds in the body can lead to adverse events. Pharmacokinetics study testing should incorporate sufficient sampling times during compound elimination for appropriate assessments of parameters such as elimination half-life and clearance.

A typical PK study in mice involves two drug delivery routes (e.g. PO and IV), 6 time points for each route (for example: 5, 15, 30, 60, 120, 240 min for IV and 15, 30, 60, 120, 240 and 360 min for PO) and 4 animals per each time point group/route, plus the common control plasma of Vehicle dosed group, 50 animals in total. We will prepare blood plasma samples and measure compound concentrations by LC-MS/MS using AB Sciex API4000/3000 mass spectrometers and Shimadzu (Prominence, VP) HPLC systems.

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