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Gotowe bibliografie tematyczne / Efficacy and quality of the drug product / Książki

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Książki na temat „Efficacy and quality of the drug product”

Autor: Grafiati

Data publikacji: 2 czerwca 2025

Data aktualizacji: 31 lipca 2025

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Sprawdź 35 najlepszych książek naukowych na temat „Efficacy and quality of the drug product”.

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1

1940-, Cartwright A. C., and Matthews Brian, eds. International pharmaceutical product registration: Aspects of quality, safety and efficacy. Ellis Horwood, 1994.

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Jameel, Feroz, Susan Hershenson, Mansoor A. Khan, and Sheryl Martin-Moe, eds. Quality by Design for Biopharmaceutical Drug Product Development. Springer New York, 2015. http://dx.doi.org/10.1007/978-1-4939-2316-8.

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Khan, Mansoor A., Feroz Jameel, Susan Hershenson, and Sheryl Martin-Moe. Quality by design for biopharmaceutical drug product development. Springer, 2015.

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1940-, Cartwright A. C., and Matthews Brian, eds. International pharmaceutical product registration. 2nd ed. Informa Healthcare, 2009.

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5

Great Britain. Medicines Control Agency., ed. Towards safe medicines: A guide to the control of safety, quality and efficacy of human medicines in the United Kingdom. HMSO, 1993.

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6

Quality, American Society for, ed. Data integrity and compliance: A primer for medical product manufacturers. ASQ Quality Press, 2019.

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7

Randall, Jonathan A. Issues and impacts of foreign pharmaceuticals. Nova Science, 2011.

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8

United States. Congress. House. Committee on Commerce. Subcommittee on Oversight and Investigations. Counterfeit bulk drugs: Hearings before the Subcommittee on Oversight and Investigations of the Committee on Commerce, House of Representatives, One Hundred Sixth Congress, second session, June 8 and October 3, 2000. U.S. G.P.O., 2000.

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9

R, Berndt Ernst, and National Bureau of Economic Research., eds. The roles of marketing, product quality and price competition in the growth and composition of the U.S. anti-ulcer drug industry. National Bureau of Economic Research, 1994.

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10

Office, General Accounting. Drug safety: Most drugs withdrawn in recent years had greater health risks for women. U.S. General Accounting Office, 2001.

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11

Office, General Accounting. Medical technology: Quality assurance systems and global markets : report to the Chairman, Subcommittee on Health and the Environment, Committee on Energy and Commerce, House of Representatives. The Office, 1993.

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12

Weinberg, Sandy. Cost-contained regulatory compliance: For the pharmaceutical, biologics, and medical device industries. John Wiley & Sons, 2011.

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13

Nichols, Eve K. Expanding access to investigational therapies for HIV infection and AIDS: March 12-13, 1990, conference summary. National Academy Press, 1991.

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14

Cartwright, A. C., and Brian Matthews. International Pharmaceutical Product Registration: Aspects of Quality, Safety and Efficacy. Taylor & Francis Group, 2013.

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15

Scientific Foundations for Regulating Drug Product Quality. AAPS Press, 1997.

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16

Yarnell, Eric, Kathy Abascal, and G. M. D. Hooper Carol. Botanical Medicine: Efficacy, Quality Assurance and Regulation. Mary Ann Liebert, 1999.

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17

Khan, Mansoor A., Feroz Jameel, Susan Hershenson, and Sheryl Martin-Moe. Quality by Design for Biopharmaceutical Drug Product Development. Springer New York, 2016.

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18

Phillips, Joseph, and Satish K. Singh. Quality by Design Model for Biologics Drug Product Development. Wiley & Sons, Incorporated, John, 2020.

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19

Kolhe, Parag, Mrinal Shah, and Nitin Rathore. Sterile Product Development: Formulation, Process, Quality and Regulatory Considerations. Springer London, Limited, 2013.

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20

Kolhe, Parag, Mrinal Shah, and Nitin Rathore. Sterile Product Development: Formulation, Process, Quality and Regulatory Considerations. Springer New York, 2016.

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21

Kolhe, Parag, Mrinal Shah, and Nitin Rathore. Sterile Product Development: Formulation, Process, Quality and Regulatory Considerations. Springer, 2013.

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22

Rahman, Mahfoozur, Sarwar Beg, Sunil Kumar Panda, Syed Sarim Imam, and Majed Al Robaian. Pharmaceutical Drug Product Development and Process Optimization: Effective Use of Quality by Design. Apple Academic Press, Incorporated, 2020.

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23

Rahman, Mahfoozur, Sarwar Beg, Sunil Kumar Panda, Syed Sarim Imam, and Majed Al Robaian. Pharmaceutical Drug Product Development and Process Optimization: Effective Use of Quality by Design. Apple Academic Press, Incorporated, 2020.

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24

Rahman, Mahfoozur, Sarwar Beg, Sunil Kumar Panda, Syed Sarim Imam, and Majed Al Robaian. Pharmaceutical Drug Product Development and Process Optimization: Effective Use of Quality by Design. Apple Academic Press, Incorporated, 2020.

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25

Rahman, Mahfoozur, Sarwar Beg, Sunil Kumar Panda, Syed Sarim Imam, and Majed Al Robaian. Pharmaceutical Drug Product Development and Process Optimization: Effective Use of Quality by Design. Apple Academic Press, Incorporated, 2020.

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26

FDA inspections: A guide for medical device and diagnostic manufacturers. Interpharm Press, 1997.

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27

Medical technology: Quality assurance systems and global markets : report to the Chairman, Subcommittee on Health and the Environment, Committee on Energy and Commerce, House of Representatives. The Office, 1993.

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28

Medical technology: Quality assurance systems and global markets : report to the Chairman, Subcommittee on Health and the Environment, Committee on Energy and Commerce, House of Representatives. The Office, 1993.

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29

Welch, Mary R., and Craig Nolan. Chemotherapy and Radiation Therapy. Oxford University Press, 2017. http://dx.doi.org/10.1093/med/9780199937837.003.0143.

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Neurotoxicity is a common problem in oncology practice and neurologists who care for cancer patients encounter a wide range of symptoms attributable to the side effects of radiation and/or chemotherapy. Complications involving the nervous system may be debilitating. Though generally improved by dose reduction or cessation of an offending agent, such symptoms can be irreversible and frequently have a profound impact on quality of life. The appropriate balance between therapeutic efficacy and drug or radiation toxicity requires close attention to the patient’s complaints as well as a thorough un

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30

Li, Madeline, Joshua Rosenblat, and Gary Rodin. Psychopharmacologic Management of Anxiety and Depression. Oxford University Press, 2017. http://dx.doi.org/10.1093/med/9780190491857.003.0005.

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Depression and anxiety are highly prevalent in patients with cancer. Defining the quality and severity of these symptoms, along with ruling out other causes for them, is required before treatment is initiated. The continuum of symptoms of depression or anxiety ranges from a normative response to more severe symptoms. Pharmacological management of depression and anxiety should be reserved for the latter, often in conjunction with psychotherapeutic interventions. Relative efficacy, adverse effects, and potential drug–drug interactions should be considered in the selection of medications. Antidep

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31

Wakeman, Sarah E., and Josiah D. Rich. Pharmacotherapy for substance use disorders within correctional facilities. Oxford University Press, 2015. http://dx.doi.org/10.1093/med/9780199360574.003.0046.

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Drug addiction treatment is increasingly complex. Only 5% of prisons and 34% of jails offer any detoxification services, and only 1% of jails offer methadone for opioid withdrawal. Even fewer facilities offer medication assisted therapy (MAT) for alcohol or substance use disorders despite the tremendous evidence base supporting the use of medications to treat addiction. Untreated opioid dependence both within corrections and in the community is associated with HIV, Hepatitis C, crime, and death by overdose. Substantial evidence argues that these risks are reduced through long-term treatment wi

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Wakeman, Sarah E., and Josiah D. Rich. Pharmacotherapy for substance use disorders within correctional facilities. Oxford University Press, 2017. http://dx.doi.org/10.1093/med/9780199360574.003.0046_update_001.

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Drug addiction treatment is increasingly complex. Only 5% of prisons and 34% of jails offer any detoxification services, and only 1% of jails offer methadone for opioid withdrawal. Even fewer facilities offer medication assisted therapy (MAT) for alcohol or substance use disorders despite the tremendous evidence base supporting the use of medications to treat addiction. Untreated opioid dependence both within corrections and in the community is associated with HIV, Hepatitis C, crime, and death by overdose. Substantial evidence argues that these risks are reduced through long-term treatment wi

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33

Zhang, Weiya, and Michael Doherty. Guidelines. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780199668847.003.0037.

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A number of treatment guidelines have been developed to optimize the treatment of osteoarthritis, some of which were recently updated. Fifty-one non-pharmacological, pharmacological, and surgical treatments are addressed in these guidelines but only two (oral opioid and intra-articular steroid injection) reach the minimal clinically important difference above placebo. Recommendations for these treatments vary depending on joint sites, risk:benefit ratio, and population. Exercise, self-management, and weight reduction if obese are universally recommended. While topical non-steroidal anti-inflam

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34

Medicine, Institute of, and Roundtable for the Development of Drugs and Vaccines Against AIDS. Expanding Access to Investigational Therapies for HIV Infection and AIDS. National Academies Press, 1991.

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Expanding Access to Investigational Therapies for HIV Infection and AIDS. National Academies Press, 1991.

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