What is Clinical Trial?

What is Clinical Trial?

“A clinical trial is defi

Technorati Tags: What is Clinical Trial?

ned as a prospective study comparing the effect and value of intervention(s) against a control in human beings”.

 Why we do clinical trials?

We do not fully understand the human body and the disease to accurately predict the efficacy and toxicities of a new therapy without a clinical trial

Calculation on as such basis & anhydrous basis OR Potency calculation of an active drugs substance

ASSAY

Calculation on as such basis & anhydrous basis

EXAMPLE :

Assay of dexamethasone sodium phosphate on anhydrous basis is =99.96%

And LOD is =3.5 %

NOTE : these above values are given in COA of dexamethasone sodium phosphate.

Then

 

How to find F (factor)

EXAMPLE

Here we must know about molecular weight of dexamethasone sodium phosphate is = 516.41 g/mol

And molecular weight of dexamethasone phosphate is = 472.446 g/mol

1 gm of dexamethasone phosphate is equivalent to

So 1.1 gm of dexamethasone sodium phosphate is equivalent to 1 gm of dexamethasone phosphate.

CALCULATI ON OF ACTUAL QUANTITIY OF AN ACTIVE MATERIAL FOR A BATCH MANUFACTURING

 

Here actual quantity of an active material required to manufacture a batch is calculated using the following formula

Here F = factor = 1.036

Label claim of dexamethasone sodium phosphate is 4.4 mg/ml

Batch size is = 120 litre

So 0.547 gm of dexamethasone sodium phosphate is required to make a 120 litre of batch.

Note - Sometimes overages also taken to make the result upto 100% so the percent of overages is depend on the particular active material.

If we take 3% overages

Then

So a total sum of 547 + 16.41 = 563.41 gm of dexamethasone is taken for a batch size of 120 litre.

 

 

ASSAY Calculation on as such basis & anhydrous basis

ASSAY

Calculation on as such basis & anhydrous basis

EXAMPLE :

Assay of dexamethasone sodium phosphate on anhydrous basis is =99.96%

And LOD is =3.5 %

NOTE : these above values are given in COA of dexamethasone sodium phosphate.

Then

How to find F (factor)

EXAMPLE

Here we must know about molecular weight of dexamethasone sodium phosphate is = 516.41 g/mol

And molecular weight of dexamethasone phosphate is = 472.446 g/mol

1 gm of dexamethasone phosphate is equivalent to

So 1.1 gm of dexamethasone sodium phosphate is equivalent to 1 gm of dexamethasone phosphate.

CALCULATION OF ACTUAL QUANTITIY OF AN ACTIVE MATERIAL FOR A BATCH MANUFACTURING

Here actual quantity of an active material required to manufacture a batch is calculated using the following formula

Here F = factor = 1.036

Label claim of dexamethasone sodium phosphate is 4.4 mg/ml

Batch size is = 120 litre

So 0.547 gm of dexamethasone sodium phosphate is required to make a 120 litre of batch.

Note - Sometimes overages also taken to make the result upto 100% so the percent of overages is depend on the particular active material.

If we take 3% overages

Then

So a total sum of 547 + 16.41 = 563.41 gm of dexamethasone is taken for a batch size of 120 litre.

Benefits of Brinjal

Benefits of Brinjal

Brinjal is high in water content and potassium. It is supposed to possess many medicinal properties and is used as a remedy for cancer, hypertension and diabetes.

Benefits of Brinjal

1. Eating brinjals roasted on fire after putting some salt into it cures excessive phlegm and wind humor of the body. 2. Soup made up of brinjal and tomato increases the appetite and helps in digestion.

Beetroot (chukandar) values and health benefits: A View

Beetroot (chukandar) values and health benefits: A View

Also called beet, the beetroot is a firm, clean globe shaped vegetable with no soft wet areas. If still attached, it should have fresh, clean young leaves. The beetroot is characterized by dark purple skin and a distinctive purple flesh. There are multiple benefits of beetroot and some of them are: Beetroot is a natural detoxifier and blood purifier.

Nutritional Value & Calories In Spinach OR PALAK

Nutritional Value & Calories In Spinach OR PALAK

Amount: 1 cup

Total Weight: 30 g

Nutrients	Amount
Basic Components
Proteins	858 mg
Water	27.4 g
Ash	0.5 g
Phytosterols	2.7 mg
Calories
Total Calories	6.9
Calories From Carbohydrates	3.9
Calories From Fats	0.98
Calories From Proteins	2.1
Carbohydrates
Total Carbohydrates	1.1 g
Dietary Fiber	660 mg
Sugar	126 mg
Fats & Fatty Acids
Total Fat	117 mg
Saturated Fat	19 mg
Monounsaturated Fat	3 mg
Polyunsaturated Fat	50 mg
Omega-3 Fatty Acids	41 mg
Omega-6 Fatty Acids	7.8 mg
Vitamins
Vitamin A	2813 IU
Vitamin C	8.4 mg
Vitamin E	609 mcg
Vitamin K	145 mcg
Thiamin	23 mcg
Riboflavin	57 mcg
Niacin	217 mcg
Vitamin B6	59 mcg
Folate	58 mcg
Pantothenic Acid	20 mcg
Choline	5.4 mg
Betaine	165 mg
Minerals
Calcium	30 mg
Iron	813 mcg
Magnesium	24 mg
Phosphorus	15 mg
Potassium	167 mg
Sodium	24 mg
Zinc	159 mcg
Copper	39 mcg
Manganese	269 mcg
Selenium	0.3 mcg

How many calories in spinach (per 100 g)

Spinach has about 23 calories per 100 g of weight.

How to Buy Spinach

• When buying spinach, make sure that the leaves and stems are crispy and dark green in color.
• Avoid spinach whose leaves and stems appear yellowish or pale green and are wilted and bruised, as the spinach has started to turn or is already bad. Also, make sure that there is no slimy coating as this is an indication of decay.
• If you are purchasing prepackaged spinach, check if there is any water or condensation inside the package or whether the leaves appear wet or mushy. Buy the package that seems to be free from all this.

Spinach Storage Tips

• Fresh spinach can be stored in the refrigerator at 2-5 degrees C for 2-3 days and should be consumed within that period.
• Don’t wash the spinach before storing in the refrigerator as exposure to water encourages spoilage. Place it in a plastic bag before putting it in the refrigerator.
• Store spinach away from other fruits and vegetables as it is ethylene sensitive and may turn bitter in taste.
• Spinach can also be frozen and kept fresh for 8 months but make sure to blanch it for 2-3 minutes before putting it into the freezer.

· More About Spinach

Quantity:	100 grams
Calories:	23 Calories in 100 grams
Bio-Logical name:	Spinacia oleracea
Spinach in other languages:	Hindi Palak Tamil Pasalai Keerai Malayalam Vasala Cheera Telugu Pachchali Koora Bengali Palang Sag Oriya Palanga Saga Gujarati Palak Marathi Palak Urdu Palak Punjabi Palak

Health benefits of tomatoes

Health benefits of tomatoes

include treating urinary tract infections, skin ailments and diabetes, lowering hypertension, and they are also good for gut health and eyesight. Tomato is considered both a vegetable and fruit and forms an integral part of cuisine round the globe. It boosts the health of a person if consumed daily. It contains numerous antioxidants which combat various types of cancer. Also tomato is rich in minerals and vitamins and also protects the heart from cardiovascular diseases. Also, tomato prevents urinary tract infections and hypertension, and promotes eye health.