wyszukanych pozycji: 46
Biopharmaceutical Manufacturing, Volume 2: Unit processes
ISBN: 9780750331777 / Angielski / Twarda / 2022 / 350 str. Termin realizacji zamówienia: ok. 30 dni roboczych. |
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cena:
656,46 zł |
Handbook of Pharmaceutical Manufacturing Formulations, Third Edition
ISBN: 9781032917252 / Multiple-item retail product / 14-10-2024 / 2200 str. Książka dostępna od: 14-10-2024 |
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Planowany termin premiery książki: 14-10-2024
Książkę można już zamówić z rabatem 5% |
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2715,42 zł |
Biopharmaceutical Manufacturing, Volume 1: Regulatory processes
ISBN: 9780750331739 / Angielski / Twarda / 2021 / 350 str. Termin realizacji zamówienia: ok. 30 dni roboczych. |
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cena:
656,46 zł |
Biosimilarity
ISBN: 9781032652351 / Angielski / Miękka / 2023 / 436 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. Summary: The focus of this book is on how the U.S. FDA will approve biosimilar drugs, as learned from recent approvals by the FDA. Understanding the limitations of the statutory limits and non-inferiority testing are presented as tools to obviate patient trials and minimize testing of immunogenicity. An in-depth scientific, mathematical and statistical view of the tools required to establish biosimilarity of biological drugs of different complexity -- a must for every developer of biosimilars. Features: First comprehensive analysis based... Summary: The focus of this book is on how the U.S. FDA will approve biosimilar drugs, as learned from recent approvals by the FDA. ... |
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cena:
239,01 zł |
Handbook of Pharmaceutical Manufacturing Formulations, Third Edition
ISBN: 9781138103924 / Angielski / Mixed Media Product / 2019 / 2200 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. |
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cena:
5196,98 zł |
Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Two, Uncompressed Solid Products
ISBN: 9781138103160 / Angielski / Twarda / 2019 / 420 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. |
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cena:
1143,33 zł |
Handbook of Pharmaceutical Manufacturing Formulations: Volume Three, Liquid Products
ISBN: 9781138113794 / Angielski / Miękka / 2018 / 400 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. |
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cena:
374,13 zł |
Handbook of Pharmaceutical Manufacturing Formulations: Volume One, Compressed Solid Products
ISBN: 9781032931296 / Angielski / 14-10-2024 Książka dostępna od: 14-10-2024 |
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Planowany termin premiery książki: 14-10-2024
Książkę można już zamówić z rabatem 5% |
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227,06 zł |
Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Four, Semisolid Products
ISBN: 9781032919232 / Angielski / 14-10-2024 Książka dostępna od: 14-10-2024 |
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Planowany termin premiery książki: 14-10-2024
Książkę można już zamówić z rabatem 5% |
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227,06 zł |
The Future of Pharmaceuticals: A Nonlinear Analysis
ISBN: 9780367705640 / Angielski / Twarda / 2022 / 568 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. |
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cena:
1455,15 zł |
Handbook of Biogeneric Therapeutic Proteins: Regulatory, Manufacturing, Testing, and Patent Issues
ISBN: 9780367454814 / Angielski / Miękka / 2019 / 584 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. More than 20 billion dollars worth of biopharmaceuticals are scheduled to go off-patent by 2006. Given the strong political impetus and the development of technological tools that can answer the questions regulatory authorities may raise, it is inevitable that the FDA and EMEA will allow biogeneric or biosimilar products. Even with all the regulatory wrinkles yet to be ironed out, generic or similar biological products are soon to become a reality. Handbook of Biogeneric Therapeutic Proteins is the first book to review and analyze the status of biotechnology, regulatory environment,...
More than 20 billion dollars worth of biopharmaceuticals are scheduled to go off-patent by 2006. Given the strong political impetus and the developmen...
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cena:
306,57 zł |
Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Four, Semisolid Products
ISBN: 9781138103306 / Angielski / Twarda / 2019 / 502 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. |
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cena:
1143,33 zł |
Handbook of Preformulation: Chemical, Biological, and Botanical Drugs, Second Edition
ISBN: 9781138297555 / Angielski / Twarda / 2019 / 544 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. |
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cena:
1091,37 zł |
Biosimilarity: The FDA Perspective
ISBN: 9781498750394 / Angielski / Twarda / 2018 / 436 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. The focus of this book is on how the US FDA will approve biosimilar drugs. The European scene is well developed with specific guidelines that are already in place. However, these guidelines do not apply to the thinking of the FDA in approving these products. The FDA is quite different from other regulatory agencies. With the US providing more than 50% of the worldwide market for these products, every serious manufacturer of biosimilar biological drugs should be targeting US approval of their products. Thus, this book is strictly on FDA approval strategy. The focus of this book is on how the US FDA will approve biosimilar drugs. The European scene is well developed with specific guidelines that are a... |
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cena:
909,47 zł |
Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Six, Sterile Products
ISBN: 9781032919737 / Angielski / 14-10-2024 Książka dostępna od: 14-10-2024 |
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Planowany termin premiery książki: 14-10-2024
Książkę można już zamówić z rabatem 5% |
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227,06 zł |
Handbook of Bioequivalence Testing
ISBN: 9781482226379 / Angielski / Twarda / 2014 / 1007 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct adequate, efficient bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence. In addition, advances in the analytical technology used to detect drug and metabolite levels have made bioequivalence testing more complex. The second edition of Handbook of Bioequivalence Testing has been completely updated to include the most current information available, including new findings in drug delivery and dosage form design... As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct adequate, efficient bioequivalence studies. In rec... |
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cena:
961,44 zł |
Mrna Therapeutics: Fast-To-Market Strategies
ISBN: 9781032163482 / Angielski / 09-10-2024 Książka dostępna od: 09-10-2024 |
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Planowany termin premiery książki: 09-10-2024
Książkę można już zamówić z rabatem 5% |
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232,00 zł |
Mrna Therapeutics: Fast-To-Market Strategies
ISBN: 9781032163444 / Angielski / Twarda / 2022 / 304 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. |
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cena:
675,61 zł |
Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Six, Sterile Products
ISBN: 9781138103832 / Angielski / Twarda / 2019 / 452 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. |
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cena:
1143,33 zł |
Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume One, Compressed Solid Products
ISBN: 9781138102804 / Angielski / Twarda / 2019 / 554 str. Termin realizacji zamówienia: ok. 16-18 dni roboczych. |
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cena:
1143,33 zł |