| Subject | Date Asked | Expert |
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| Wellbutrin XL 225mg | 7/3/2009 | Dr Mohd Tariq Salman |
Q: For a few years I've been taking Wellbutrin XL at one of two dosages for months at a time, 150mg or ...
A: Wellbutrin XL 225mg is not available anywhere in the world. Wellbutrin XL and Wellbutrin SR are ...
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| Men's Health | 7/2/2009 | Dr Mohd Tariq Salman |
Q: Is propecia safe?
A: All drugs may cause side effects and you have to weigh the potential benefits versus the potential ...
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| Pharmaceuticals | 7/2/2009 | Michael Anisfeld |
Q: Have a nice Day My question is: Can we give Retesting date to Raw Material beyond its expiry date ...
A: The only GMP providing guidance on this, worldwide, is the Canadian GMPs. They state that if the ...
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| Pharmaceutical Industry | 7/1/2009 | Dr Mohd Tariq Salman |
Q: What would happen to the Pharmaceutical Industry, especially someone who has M.S. in Pharmaceutical ...
A: Pharmaceutical Industry is an evergreen field and one of the industries which are least effected by ...
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| Wellbutrin dose | 6/30/2009 | Dr Mohd Tariq Salman |
Q: Over the years I have taken two different dosages of Wellbutrin XL: 150 and 300 mg. I've generally ...
A: instead of WELLBUTRIN XL you can take WELLBUTRIN SR 100 mg twice daily. This will give you 200mg ...
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| Expiry date vs date of manufacture vs shelf life | 6/24/2009 | Michael Anisfeld |
Q: My question is regarding expiry dating which is usually expressed as month and year. If a pharma ...
A: Kevin: The date of manufacture is the date that the ingredients first get to meet each other, say ...
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| Reprocess of nearing expiry drug substance | 6/22/2009 | Michael Anisfeld |
Q: One of my friends wants to reprocess the nearing expiry drug substance. If he does, then What would ...
A: you can do this on two conditions: a. you have stability data (at a minimum 6 months accelerated ...
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| pharmacy related | 6/16/2009 | Dr Mohd Tariq Salman |
Q: actually i m here at onsite and i have tab of erythromycin of government supply of mfg date of ...
A: expiry date depends on salt active ingredient used, type of tablet and manufacturer. In this case ...
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| Nitrofur | 6/13/2009 | Dr Mohd Tariq Salman |
Q: Should a woman who is taking Nitrofur continue to breastfeed an infant who is two weeks old? What ...
A: Nitrofurantoin is excreted into human milk. It is considered compatible with breast-feeding by ...
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| drug interactions with methadone | 6/8/2009 | Dr Mohd Tariq Salman |
Q: what are the drugs that you cannot take while on methadone? I know there are some that will start
A: 1. Opioid Antagonists, Mixed Agonist/Antagonists, and Partial Agonists Patients maintained on ...
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| Antibiotics | 6/4/2009 | Dr Mohd Tariq Salman |
Q: . I recently had my wisdom teeth (all 4) pulled. that went well so far and i haven't had any issues. ...
A: You are most probably having oral candidiasis, which develops due to alteration of normal oral ...
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| Microbiological testing of pharmaceutical stability samples | 11/5/2008 | Michael Anisfeld |
Q: I saw your answer regarding the frequency of testing for stability and wonder if microbiological ...
A: If the study is to establish an expiration date for a new product, then microbial testing is ...
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| zaleplon | 10/30/2008 | Michael Anisfeld |
Q: Can you tell me how to obtain zaleplon in Canada? It used to be available as Starnoc, but appears ...
A: Humble and profuse apologies. I was mixing the drug in my mind with Zolpidem (sold here as Ambien) ...
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| zaleplon | 10/29/2008 | Michael Anisfeld |
Q: Can you tell me how to obtain zaleplon in Canada? It used to be available as Starnoc, but appears ...
A: Zaleplon is sold in the USA as Ambien. It is banned in Canada and is not available there. I ...
|
| Vertical form fill seal machines | 10/7/2008 | Michael Anisfeld |
Q: We are trying to place powdered nutritional supplements into a 3 or 4 sided pouch. It is a fine ...
A: Vicki: Many moons ago I used to run a powder fill line for pharmaceutical products, and will share ...
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| microbiological testing in pharmaceuticals | 9/23/2008 | Michael Anisfeld |
Q: Can I get rid off Autoclave if I use 'ready to use media / plates/ tubes' in the microbiological ...
A: JK: I wish you could, but have you thought about how you will decontaminate the growth plates after ...
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| Brand Name Synthroid vs. Generic | 9/22/2008 | Michael Anisfeld |
Q: My doctor, who I respect, and his entire endocrinology practice at a major Baltimore hospital, ...
A: As the FDA has approved generic Synthroid as bio-equivalent to the original brand, you will have a ...
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| Freeze Thaw Study | 9/20/2008 | Michael Anisfeld |
Q: I would like to know how is freeze/thaw study carried out for Liquid oral products with references, ...
A: Take your liquid product, cool at -5oC to freeze, and hold frozen for 24 hours; then thaw at room ...
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| Drug Safety | 9/18/2008 | Michael Anisfeld |
Q: I get extremely intense anxiety when flying on airplanes. A few years ago, I went to a doctor and ...
A: All drugs degrade from the date of manufacture, losing effectiveness and potentially building up ...
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| Clonidine and Atenolol manufacturing | 9/12/2008 | Michael Anisfeld |
Q: I have a question about these two medications. My mother takes both for her high blood pressure and ...
A: Sheryl: Welcome to the wonderful world of generic drugs. When the product patent expires, ...
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| Quality Index in pharmaceuticals | 8/21/2008 | Michael Anisfeld |
Q: What is quality index.pls give the importance of it.Is their any reference for this.
A: There is no uniform definition, and many people use the term in may different ways. As examples, ...
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| writing the dossier when only CEP is available | 8/12/2008 | Michael Anisfeld |
Q: I have a problem, I need to write a registration documentation in EU format (not CTD) - the IIF ...
A: I commiserate with you, having been in the same situation a few years back. The EU reviewers demand ...
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| stability/balance calibration | 7/26/2008 | Michael Anisfeld |
Q: stability what to do if our product shows significant change in accelerated condition calibration ...
A: stability - by "change" in stability - do you mean that the product does not meet its specification ...
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| generic drugs -- not quite the same | 7/23/2008 | Michael Anisfeld |
Q: Are you aware, that by law, generic drugs do not have to bioidentical? Meaning they can contain ...
A: Lori: Sorry, but I completely disagree with you. According to the Good Manufacturing Practices ...
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| Hi | 7/10/2008 | Michael Anisfeld |
Q: Can you suggest me what is most acceptable date format or most suited date format in Industry ...
A: Most of the industry uses the ISO Standard date format. This is YYYY-MMM-DD. So today's date July ...
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| Hi | 7/10/2008 | Michael Anisfeld |
Q: Not for any question, But I got your profile so contacted We met at Artemis Biotech, Hyderabad; ...
A: Soni: Yes indeed I do remember you. What are you doing now and how is it going? Incidentally, what ...
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| Sampling conditions for non sterile raw materials | 7/10/2008 | Michael Anisfeld |
Q: I wanted to know if there are any environmental conditions that should be adhered to for non ...
A: Sampling for chemical testing is routinely performed in a Class 100,000 (ISO Class 8) environment. ...
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| Stability samples transfer | 7/9/2008 | Michael Anisfeld |
Q: I would like to know is it ok to transfer a stability study from one country to another during the ...
A: In principle I do not see any problem with this except one. The transportation issues are not of ...
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| FBD bag | 6/6/2008 | Michael Anisfeld |
Q: I would like to know about the "material Of Construction" (MOC) of FBD bag. Thank you very much, ...
A: You must, I repeat MUST, personally audit the bag fabricator - and take someone with you who knows ...
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| Shelf life of Chantix... | 5/20/2008 | Michael Anisfeld |
Q: My girlfriend is taking Chantix. She has a prescription of course (and it seems to be working!). ...
A: Look at the outside of the carton the Chantix came in. If the expiration date is still within its ...
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| amoxicillin/clavulanic acid | 5/20/2008 | Michael Anisfeld |
Q: just wanted to ask what exactly is this medication. I tried to look it up but couldn't find ...
A: It is a very effective broad spectrum antibiotic. If you Google Augmentin, (make sure you spell it ...
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| new energy vitamin | 5/2/2008 | Michael Anisfeld |
Q: what is the best way to get my new energy vitamin produced. I know there are thousands of vitamin ...
A: The best way would be to find an existing Vitamin manufacturer who is willing to engage in contact ...
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| Bulk product stability | 5/1/2008 | Michael Anisfeld |
Q: We are using Hexagonal Corrugated boxes with double lined polybags with a desccant bag in between to ...
A: Sorry, but I need clarification in order to answer. The Hexagonal Corrugated Boxes - are they used ...
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| Stability | 4/30/2008 | Michael Anisfeld |
Q: "Dear Mr.Michael/ Ihope that you are in the best mode: I have two questions: 1)If time for ...
A: Q1. Seems like you are tying yourself in knots about this. The key question you really need to ask ...
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| Stability | 4/30/2008 | Michael Anisfeld |
Q: "Dear Mr.Michael/ Ihope that you are in the best mode: I have two questions: 1)If time for ...
A: Moayyad: You hope I am in the "best mode" - I am not sure what you mean my this, but I am fine - ...
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| Raw Material storage requirements | 4/29/2008 | Michael Anisfeld |
Q: what is meant by "Store in cool and dry place" in pharmaceutical raw material storage. We often use ...
A: Irfan: According to USP definitions (USP31): "Cool" — Any temperature between 8oC and 15oC (46 ...
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| test or no the bulk? | 4/10/2008 | Michael Anisfeld |
Q: A bulk of tablets was made 2 months ago. It has been waiting since then to be put in the primary ...
A: FDA allows up to 30 days storage without the need for supporting stability data on the bulk. as such ...
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| preparation of two batches | 4/7/2008 | Michael Anisfeld |
Q: please is it comply to GMP to prepared batche in one holding tank and filled in to two different ...
A: A batch is defined as a homogenous mixture. As such your single tank formulation is ONE batch. When ...
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| Endotoxin | 3/20/2008 | Michael Anisfeld |
Q: What is the significance of testing endotoxins in parentral preperation .the normal limit is found ...
A: The presence of endotoxins can cause a cascade of body reactions/degradations leading to death ...
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| bulk stability | 3/12/2008 | Michael Anisfeld |
Q: We would like to complete bulk stability on our drug product (and/or intermediates) in small fibre ...
A: If you drug product is an "active pharmaceutical ingredient" (API), then you can keep your stability ...
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