Pharmaceutical Toxicology in Practice: A Guide to Non-clinical Development

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Drug discovery and development process

Imprint: Academic Press. Published Date: 16th November Page Count: For regional delivery times, please check When will I receive my book? Sorry, this product is currently out of stock. Flexible - Read on multiple operating systems and devices. Easily read eBooks on smart phones, computers, or any eBook readers, including Kindle.

In Vivo Toxicology: Toxicology Studies

When you read an eBook on VitalSource Bookshelf, enjoy such features as: Access online or offline, on mobile or desktop devices Bookmarks, highlights and notes sync across all your devices Smart study tools such as note sharing and subscription, review mode, and Microsoft OneNote integration Search and navigate content across your entire Bookshelf library Interactive notebook and read-aloud functionality Look up additional information online by highlighting a word or phrase. Institutional Subscription. Free Shipping Free global shipping No minimum order. Provides unique content that is not always covered together in one comprehensive resource, including chapters on stem cells, abuse liability, biomarkers, inhalation toxicology, biostatistics, and more Updated with the latest international guidelines for nonclinical toxicology in both small and large molecules Incorporates practical examples in order to illustrate day-to-day activities and the expectations associated with working in nonclinical toxicology.

Dedication List of Contributors Foreword Chapter 1. Introduction Section I. Drug Discovery, Metabolism, and Pharmacokinetics Chapter 2. Clinical Pathology, Histopathology, and Biomarkers Chapter Conclusions Chapter Specialty Route of Administration Chapter Powered by. You are connected as.

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Pharmaceutical Toxicology in Practice: A Guide to Non-clinical Development

Ratings and Book Reviews 0 0 star ratings 0 reviews. Overall rating No ratings yet 0. How to write a great review Do Say what you liked best and least Describe the author's style Explain the rating you gave Don't Use rude and profane language Include any personal information Mention spoilers or the book's price Recap the plot.

Close Report a review At Kobo, we try to ensure that published reviews do not contain rude or profane language, spoilers, or any of our reviewer's personal information. Would you like us to take another look at this review? A brief history of the regulatory perspective of drugs which provides. A brief history of the regulatory perspective of drugs which provides background to the current study designs presented in the chapter is discussed. The initial FDA guidelines and the subsequent International Conference on Harmonisation ICH S5 R2 currently used for the assessment of potential developmental and reproductive toxicity for safety evaluations of medicinal products are in some measure a testament of the endeavor of government authorities to prevent future tragedies, such as that of Thalidomide.

The chapter incorporates reviews of the basic requirements for Conducting Fertility, Embryo—Fetal Development, and Prenatal and Postnatal Developmental Toxicology Studies as core components of pharmaceutical drug development programs.

IND Applications for Clinical Investigations: Pharmacology and Toxicology (PT) Information | FDA

With the increase in biopharmaceutical development, the chapter also includes consideration for evaluating Reproductive and Developmental Toxicity in nontraditional animal models. Alternative methods for in vitro evaluations of reproductive and developmental toxicology are also reviewed in this chapter. Embryonic stem cell test, Nonhuman primate, Dose selection, Embryo—fetal development, Fertility and early embryonic development, Prenatal and postnatal developmental toxicity, Maternal observations, Postweaning assessments, Juvenile toxicity studies.

Abstract This chapter reviews the current regulatory considerations for reproductive and developmental toxicology testing specifically relating to pharmaceuticals and biopharmaceuticals.

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Related articles Based on techniques. References Lenz W A short history of thalidomide embryopathy.

In Vivo Toxicology Test Categories

Teratology — Zimmer C March 15, Answers begin to emerge on how thalidomide caused defects. Free download.