Biosimilars - Samenvattingen, Notities en Examens

Pharmaceutical Biotechnology - ***Use of recombinant DNA and sequencing technology to manipulation biological materials What fields do we use biotechnology in? - ***Agriculture Health Care Environment (biofuels) Advantages of Using Recombinant DNA for Drug Development - ***1. Source availability - Overcomes low natural abundance of molecules 2. Safety 3. Engineering - can engineer for "drug-like" properties 4. Economical - without rDNA, biological drugs would be too expensive Biosi...

[Manufacturing Plan] As part of a robust manufacturing plan, to increase assurance of consistency in product quality from batch to batch of manufactured drug, part of the manufacturing plan is to have ___________ in place. " - Answer- process validation plan [PCR procedures] Which drug development department may be responsible for developing PCR procedures to test for the proper integration of a gene therapy construct in the genome of treated patients? - Answer- Assay development group [S...

Explain the interdisciplinary nature of pharmacology Answer> Everyone in the health care team uses it and studies it. Began with chemists isolating substances and then evolved into pharmacologists studying the drug effects in animals. Today, nurses and doctors all consult with pharmacists about their patients. 3 General categories of medications Answer> Drugs, Biologics or Biosimilars, and CAM (complementary or alternative medicine therapy) 2 Ways to classify drugs Answer> ...

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CYP INHIBITORS - CORRECT ANSWER **G PACMAN** Grapefruit Protease inhibitors (Ritonavir) Azole antifungals C - cyclosporine, cimetidine, cobicistat Macrolides (NOT azithromycin) Amiodarone (and dronedarone) Non-DHP CCBs CYP INDUCERS - CORRECT ANSWER **PS PORCS** Phenytoin Smoking Phenobarbital Oxcarbazepine (and eslicarbazepine) Rifampin Carbamazepine (also auto-inducer) St. Johns wort Digoxin Levels - CORRECT ANSWER 0.8-2 (Afib) 0.5-0.9 (HF) Toxicity: ...

BCSCP Exam Questions and Answers | 100% Pass!! USP Supplements -Answer-First published in Feb, official Aug 1. Second published in June, official Dec 1. Public Health Service Act -Answer-Biologics License Application (BLA) 351(k) pathway for biosimilars Enforcement of USP Standards -Answer-Responsibility of FDA and other govt authorities. USP has no role in enforcement "About" -Answer-Indicates a quantity within 10% USP 795 bulk product expiration -Answer-Compounder shall label with d...

NAPLEX THINGS TO REMEMBER 2024 QUESTIONS WITH COMPLETE SOLUTIONS GRADED A+ CYP INHIBITORS - CORRECT ANSWER **G PACMAN** Grapefruit Protease inhibitors (Ritonavir) Azole antifungals C - cyclosporine, cimetidine, cobicistat Macrolides (NOT azithromycin) Amiodarone (and dronedarone) Non-DHP CCBs CYP INDUCERS - CORRECT ANSWER **PS PORCS** Phenytoin Smoking Phenobarbital Oxcarbazepine (and eslicarbazepine) Rifampin Carbamazepine (also auto-inducer) St. Johns wort Digoxin Leve...

Explain the interdisciplinary nature of pharmacology - Everyone in the health care team uses it and studies it. Began with chemists isolating substances and then evolved into pharmacologists studying the drug effects in animals. Today, nurses and doctors all consult with pharmacists about their patients. 3 General categories of medications - Drugs, Biologics or Biosimilars, and CAM (complementary or alternative medicine therapy) 2 Ways to classify drugs - Therapeutic: clearly states what a...

A doctor's office wants to obtain an office supply of a compounded ointment from the local pharmacy to use for his patients with neuropathic pain. Which of the following is the MOST appropriate action for the pharmacist to take? Answer A. Inform the prescriber that the pharmacy can furnish compounded preparations to prescribers for office use only. B. Inform the prescriber that he can give each patient no more than a 7-day supply from his office supply. C. Inform the prescriber that he can ...

Neoadjuvant therapy does not increase survival when compared to adjuvant therapy. It only changes the timing of treatment and can change surgical options if the tumor is shrunk enough. If this occurs, the patient may only require a lumpectomy plus radiation therapy instead of needing a mastectomy - Correct answer-Main benefit of neoadjuvant chemotherapy (breast cancer patient) A comprehensive geriatric assessment (CGA) is a multidisciplinary evaluation to assess life expectancy and risk of...