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About Michael Anisfeld
(Top Expert on this page)

Expertise
Disclaimer: SORRY BUT I DO NOT ANSWER QUESTIONS RELATED TO: DRUG ACTIONS/INTERACTIONS, INTERNET DRUG PURCHASES, RESULTS OF DRUG TESTS, IDENTIFYING DRUGS (FOR WHICH YOUR LOCAL PHARMACIST IS THE BEST PERSON TO CONSULT). My expertise is answering questions relating to pharmaceutical manufacturing and quality technologies, drug regulations and specifically GMP requirements

Experience

Past/Present Clients
UN agencies (UNFPA, UNICEF, UNIDO)
Governments (Australia, Canada, India, United Kingdon, United States
Companies - over 200 companies in 37 countries

   

You are here:  Experts > Health/Fitness > Pharmacology > Pharmaceuticals

SubjectDate AskedExpert

Which medicine is more effective?11/15/2009Dr Mohd Tariq Salman
  Q: I have Stage III-C clear cell endometrial carcinoma and I start chemo on Nov.17th. My oncologist has ...
  A: Ativan (lorazepam) is indicated for the management of anxiety. For optimal results, dose, frequency ...
Raw material testing11/4/2009Michael Anisfeld
  Q: Reading guidelines about raw material testing for the pharmaceutical industry, I often find the word ...
  A: The amount of testing is based on the supplier history and your confidence in the Supplier's ...
Required pressure on manometers10/30/2009Michael Anisfeld
  Q: Respected sir please send me a map of ideal ware house for pharmaceutical industry , where we could ...
  A: Why do you need to read pressure in warehouses? The key issue is temperature. If you are trying to ...
Retain Samples10/28/2009Michael Anisfeld
  Q: I am trying to determine if there are any rules FDA/Foreign that would require a retain sample for ...
  A: Interesting questions. 21CFR211.170 on Reserve Samples states: "(b) An appropriately identified ...
Off-label prescriptions10/27/2009Michael Anisfeld
  Q: I know that the FDA cannot regulate a physician's prescribing FDA approved drugs for off-label uses, ...
  A: Claire: You appear to be correct (but as I am not a lawyer, I cannot state that you legally "are ...
MAP OF DEDICATED WARE HOUSE (RAW , PACKING AND F/G )10/26/2009Michael Anisfeld
  Q: Respected sir please send me a map of ideal ware house for pharmaceutical industry , where we could ...
  A: There is no such thing as the "ideal" warehouse, as it depends on your product needs (degree of ...
Choosing between different drug manufacturing companies10/15/2009Dr Mohd Tariq Salman
  Q: india. Few monthes ago i was prescribed escitalopram when i was in Saudi Arabia and they gave it to ...
  A: you can take any brand as long as it is from a reputed company and you buy it from a reliable drug ...
Raw Material Sampling10/15/2009Michael Anisfeld
  Q: Is there any guideline which cites the quantity for Raw material sampling? Or from where this root ...
  A: You are asking two different questions. For chemicals you need to sample sufficient material to ...
API10/13/2009Michael Anisfeld
  Q: my question is how we give expiry date to a finished dose form product, and if we have an API lot ...
  A: With the exception of products sold in India (they have a unique interpretation of API stability and ...
Temperature and humidity requirement for multi vitamins and pharmaceutical excepients10/5/2009Michael Anisfeld
  Q: Respected sir i am employee of a pharmaceutical company as manager stores. would you like to brief ...
  A: The temperature/humidty requirements required in your warehouse will relate to what you are storing. ...
Need information relating to interactions10/1/2009Dr Mohd Tariq Salman
  Q: I take 0.5mg of Alprazolam (Xanax) 2x per day for anxiety. I also deal with kidney stone pain ...
  A: There are major drug-drug interactions between the two. The combination can be dangerous for some ...
Ideal and dedicated map of raw , packing ang finished goods stores in pharmaceutical industry9/29/2009Michael Anisfeld
  Q: Respected sir i am employee of a pharmaceutical company as manager stores. would you like to brief ...
  A: You need separate areas for: a. goods receipt (unloading dock) b. raw material sampling area (a ...
GMP Specifications for Relative humidity and temperature.9/28/2009Michael Anisfeld
  Q: Please what are the various classes of areas in the pharmaceutical manufacturing plant with ...
  A: According to the USP (Genral Notices), the following definitions apply: Freezer— A place in which ...
Stability testing pulling times9/28/2009Michael Anisfeld
  Q: I was wandering whether you could help with my query relating to stability testing of ...
  A: The answers you seek were covered in an FDA OGD Guideline, withdrawn a few years ago. Samples with ...
Wellbutrin & Adderall8/16/2009Dr Mohd Tariq Salman
  Q: Salman, My brother was prescribed WELLBUTRIN (bupropion) recently for two reasons. First, to help ...
  A: The use of bupropion is associated with a dose-related risk of seizures. The risk may be increased ...
pharmacuetical possible use for anxiety7/24/2009Dr Mohd Tariq Salman
  Q: I am currently taking 30mg amphetamine/dextroamphetamine (Adderall xr) for ADHD and have very high ...
  A: Acetaminophen and hydrocodone is basically a pain reliever. Since your headache was relieved, it ...
Wellbutrin XL 225mg7/3/2009Dr 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 ...
Men's Health7/2/2009Dr 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 ...
Pharmaceuticals7/2/2009Michael 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 ...
Pharmaceutical Industry7/1/2009Dr 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 ...
Wellbutrin dose6/30/2009Dr 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 ...
Expiry date vs date of manufacture vs shelf life6/24/2009Michael 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 ...
Reprocess of nearing expiry drug substance6/22/2009Michael 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 ...
pharmacy related6/16/2009Dr 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 ...
Nitrofur6/13/2009Dr 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 ...
drug interactions with methadone6/8/2009Dr 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 ...
Antibiotics6/4/2009Dr 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 ...
Microbiological testing of pharmaceutical stability samples11/5/2008Michael 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 ...
zaleplon10/30/2008Michael 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) ...
zaleplon10/29/2008Michael 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 machines10/7/2008Michael 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 ...
microbiological testing in pharmaceuticals9/23/2008Michael 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 ...
Brand Name Synthroid vs. Generic9/22/2008Michael 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 ...
Freeze Thaw Study9/20/2008Michael 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 ...
Drug Safety9/18/2008Michael 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 ...
Clonidine and Atenolol manufacturing9/12/2008Michael 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, ...
Quality Index in pharmaceuticals8/21/2008Michael 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, ...
writing the dossier when only CEP is available8/12/2008Michael 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 ...
stability/balance calibration7/26/2008Michael 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 ...
generic drugs -- not quite the same7/23/2008Michael 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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