Largest daily dosae information

GOOD VALIDATION PRACTICE (cGVP) CLEANING VALIDATION
1

Dear All

Kindly give me the website address from where i can take the Largest daily dosae information for ready reference.
is there any mode then pls. let me know.

Thanx

2

Dear Nimesh,

as per my knowledge you will not find any web site for getting an inforamtion regarding max & min Dose. you can refer


for few information.

Regards,
Ravi.B

3

thanks ravi,
i am refering this site at present.
i didnt found a suitable dose for warfarin sodium.

can you help me out.

4

Dear Mr. Nimesh,

You can refer to any pharmacology book (e.g. Martindale, Goodman & Gilman etc.), package insert or FDA’s Maximum Recommended Therapeutic Dose (MRTD) Database available here:
http://www.fda.gov/aboutfda/centersoffices/cder/ucm092199.htm
. The database contains the maximum daily dose for Warfarin. The values given in the database are in the form of mg/kg-bw/day, multiply the value by an appropriate weight (e.g. 70 for an Adult) to get the desired dose for an adult/child. This will give a maximum daily dose value for the active ingredient, divide the value by the dose of active (in your product) to get the maximum number of dosage units that can be taken per day. For example: the Maximum Recommended Therapeutic Dose for Warfarin as per the database is 0.167 mg/kg-bw/day, multiplying it with 70 kg will give the max daily dose of warfarin for an adult (i.e. 0.167 x 70 = 11.69 mg/day). Now, assuming the dose of active in your product is 5 mg of warfarin. Dividing 11.69 by 5 will give you a value = 2.338. Since the value obtained is in fraction you can round it up, then the value will become 2. This implies the maximum daily dose (in terms of dosage units) of a product containing 5mg of warfarin = 2.

Hope this clarifies.

Regards.

Ovais

5

Dear Nimesh,

as clearly explained by Ovais, you can get the details.

further the MRTD for warfarin is 0.16700 mg/kg-bw/day

Regards,

Sri

6

Dear all,
I´m trying to set cleaning validation for equipment that is used for injectable products, oncologics specifically.
When I want to make the calculations based on the minimum therapeutic dose, I´m having problems to establish it. Because if I look that in the leaflets, it´s expressed of course in X mg/m2 per week or something, so, is it correct to estimate m2 for standard (as you say, 70 kg as standard body weight)? and then dividing per week or whatever the treatment is set? So I can have quantity per day?
And how about the largest daily dose? I look in this page
http://www.fda.gov/aboutfda/centersoffices/cder/ucm092199.htm
, but I didn´t find the drugs I´m looking for…can you please help me with this subject? how is your experience with this?
Thank you very much in advance.

7

Hi Dear,

Warfarin Dosages are 0.5 mg/day to 10 mg/day.
refer site
http://www.drugs.com/pro/warfarin.html

Regards,
Satish Dange

8

[quote=mpbr82]Dear all,
I´m trying to set cleaning validation for equipment that is used for injectable products, oncologics specifically.
When I want to make the calculations based on the minimum therapeutic dose, I´m having problems to establish it. Because if I look that in the leaflets, it´s expressed of course in X mg/m2 per week or something, so, is it correct to estimate m2 for standard (as you say, 70 kg as standard body weight)? and then dividing per week or whatever the treatment is set? So I can have quantity per day?
And how about the largest daily dose? I look in this page
http://www.fda.gov/aboutfda/centersoffices/cder/ucm092199.htm
, but I didn´t find the drugs I´m looking for…can you please help me with this subject? how is your experience with this?
Thank you very much in advance.[/quote]

I have the same doubt, the oncologist does not have a constant dosage basis, varies according to patient’s condition and medication.

If anyone could set residue limits for oncologics plant … Could share some of your experience?

Thank you!