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@FRD
Liquid nitrogen is one of the safest cooling agents for pharmaceutical use. It can ensure extremely low temperature, which is required for freeze drying in lyophilization process.Liquid nitrogen also offer a wider processing window to added flexibility and productivity benefits.
- This reply was modified 10 months, 2 weeks ago by .
@FRD
You can reduce the debossing/imprinting code or you can omit it with proper justification.@FRD
Following factors are critical for BCS based biowaiver:
– Solubility of highest single therapeutic dose
– Type of Dosage Form
– Composition of Drug Product
– Mode of administration
– Comparative in vitro dissolution tests etc.Stringent Regulatory Authority
The World Health organisation (WHO) classifies a stringent regulatory authority (SRA) as a national drug regulatory authority that applies stringent quality standards, safety, and usefulness in its regulatory assessment of medicines and vaccines for marketing approval. The approval by the SRA is an indication of the product’s high degree of efficacy and safety.Less Stringent Regulatory Aauthority
A national drug regulatory authority that applies flexibiity in its regulatory assessment of medicines and vaccines for marketing approval in respect to quality standards, safety, and usefulness.In the European Union (EU), there are two main routes for authorising medicines: a centralised route and a national route.
Under the centralised authorisation procedure, pharmaceutical companies submit a single marketing authorisation application to EMA.
This allows the marketing-authorisation holder to market the medicine and make it available to patients and healthcare professionals throughout the EU on the basis of a single marketing authorisation.
EMA’s Committee for Medicinal products for Human Use (CHMP) or Committee for Medicinal products
for Veterinary Use (CVMP) carry out a scientific assessment of the application and give a recommendation on whether the medicine should be marketed or not.Once granted by the European Commission, the centralised marketing authorisation is valid in all EU Member States as well as in the EEA countries Iceland, Liechtenstein and Norway.
If a company wishes to request marketing authorisation in several EU Member States for a medicine that is outside the scope of the centralised procedure, it may use one of the following routes:
– the mutual-recognition procedure, whereby a marketing authorisation granted in one Member State can be recognised in other EU countries;
– the decentralised procedure, whereby a medicine that has not yet been authorised in the EU can be simultaneously authorised in several EU Member States.As per ACCP, Clinical pharmacists:
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– Assess the status of the patient’s health problems and determine whether the prescribed medications are optimally meeting the patient’s needs and goals of care.
– Evaluate the appropriateness and effectiveness of the patient’s medications.
– Recognize untreated health problems that could be improved or resolved with appropriate medication therapy.
– Follow the patient’s progress to determine the effects of the patient’s medications on his or her health.
– Consult with the patient’s physicians and other health care providers in selecting the medication therapy that best meets the patient’s needs and contributes effectively to the overall therapy goals.
– Advise the patient on how to best take his or her medications.
– Support the health care team’s efforts to educate the patient on other important steps to improve or maintain health, such as exercise, diet, and preventive steps like immunization.
– Refer the patient to his or her physician or other health professionals to address specific health, wellness, or social services concerns as they arise.- This reply was modified 11 months ago by .
1) production
2) facilities and equipment
3) laboratory controls
4) materials
5) packaging and labeling
6) quality management- This reply was modified 12 months ago by .
Following FBP parameters you can remain same/similar in both R&D and Production scale:
– Inlet air temperature
– Product temperature
– Atomization nozzle sizeAnd you should adjust the below parameters:
– Inlet air flow
– Spray rate
– Atomization air pressureYes, FDA requires for any solid dosage drug products of prescription or OTC be it tablets or capsules to have imprint code for product identification and to prevent fraud.
– It should be a unique identification of the drug product and the manufacturer or distributor of the product.
– It can be any single letter or number or any combination of letters and numbers.
– This is applicable for solid oral dosage form drug product.- This reply was modified 1 year ago by .
You can follow the below equation-
A = πr^2Where,
A= cross sectional surface area (m^2)
r= radious of the bottom screen (m)As per clinical pharmacology and biopharmaceutics review of Zithromax, Azithromycin fall in BCS class I or III.
Ref.: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/50-784_zithromax_biopharmr.pdf
@FRD
As far I know there is no major challenges in analytical method of Valsartan + Amlodipine Tablets. You can follow USP method.@FRD
This guideline is a basement of QbD approach. But there is a lot of guidelines and practical courses are available now.
