Search Results for: thalidomide

Thalidomide

1 Comment / Chirality / By / , , , / July 5, 2024

Thalidomide was a racemic therapeutic and prescribed to pregnant women to control nausea and vomiting. The drug was withdrawn from world market when it became evident that the use in pregnancy causes phocomelia (clinical conditions where babies are born with deformed hand and limbs). Later in late 1970s, the thalidomide enantiomers were separated and enantioselective studies indicated that the (R)- enantiomer, the good partner, is an effective sedative, the (S)-enantiomer, the evil partner, harbors teratogenic …

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Thalidomide tragedy: the story and lessons …

2 Comments / Chirality / By / , , / July 5, 2024

In the 1940s and early 1950s, pregnant women throughout the world who experienced morning sickness and other anxieties associated with the first term of pregnancy were given barbiturate sedatives for relief. The issue with these barbiturates, like most sedatives, was the fact that they were highly toxic in large doses. In 1957, Chemie Grunenthal of Germany launched thalidomide as a safer alternative to barbiturate sedatives. Thalidomide, as a new sedative, was a very “attractive” drug …

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Episode 10: Future Reflections: How the Story of Chiral Drug Regulation Continues

Leave a Comment / Chiral science, Chirality, Regulatory Affairs / By / , / June 21, 2025

“Approval is not the end of a molecule’s journey – the mirror must be watched, studied, and questioned throughout its life.” Introduction The development and approval of chiral drugs, especially single-enantiomer entities, marked a new chapter in pharmaceutical science. However, approval is only the beginning. Ensuring that a chiral drug continues to behave safely and predictably in the real world demands vigilant post-marketing surveillance, adaptive regulatory frameworks, and constant scientific reevaluation. In this final episode, …

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Episode 9: Challenges on the Horizon: Complex Chirality and Emerging Scientific Questions

Leave a Comment / Chiral science, Chirality, Regulatory Affairs / By / , / June 17, 2025

“As the molecular world grows more intricate, so do the challenges in regulating and understanding chirality.” Introduction While the 1990s and 2000s solidified regulatory frameworks for simple chiral drugs -classic single stereocenter, stable enantiomers –science has since moved into more complex territory. Today, pharmaceutical innovation increasingly deals with molecules featuring multiple stereocenters, dynamic chirality, axial chirality (atropisomerism), and stereochemical instability. These new realities stretch the existing regulatory and scientific paradigms developed for simpler chiral systems. …

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Episode 5: Choosing the Right Twin: Regulatory Expectations for Single Enantiomers

Leave a Comment / Chiral science, Chirality, Regulatory Affairs / By / , / May 29, 2025

Tagline: “When two mirror images offer different paths, how do regulators choose which one should become medicine?” Introduction The rise of regulatory consciousness around chiral drugs in the 1990s opened a crucial new question:If mirror-image molecules behave differently, how should the pharmaceutical industry -and regulators -decide which enantiomer to develop, approve, and market? This episode explores how regulatory agencies like the FDA, EMA, PMDA, CDSCO, and TGA crafted expectations for the development, approval, and control …

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Episode 4: Technology as Catalyst: How Science Enabled the Regulatory Transformation

Leave a Comment / Chiral science, Chirality, Regulatory Affairs / By / , / May 17, 2025

Tagline: “When scientific precision sharpened, so did regulatory vision -technology became the bridge between molecules and medicine.” Introduction The regulatory awakening around chiral drugs in the 1990s did not occur in isolation. It was powered, almost inevitably, by remarkable scientific and technological breakthroughs. Before sophisticated tools existed, distinguishing and isolating enantiomers was labor-intensive, error-prone, and prohibitively expensive. It was the advent of new chemical, analytical, and bioanalytical technologies that made the regulatory demands for stereochemical …

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Episode 2: The Great Shift: How the 1990s Redefined Stereochemical Standards

Leave a Comment / Chiral science / By / May 11, 2025

“When regulators caught up with science, a quiet molecular revolution began – changing the future of drug development forever.” Introduction The 1990s represent a pivotal decade in pharmaceutical regulation, where long-overlooked nuances of molecular chirality finally received the attention they deserved. Before this era, enantiomers in drug substances were treated as interchangeable entities, with few regulatory frameworks requiring detailed evaluation of each stereoisomer. However, accumulating scientific evidence, technological advances, and a few high-profile pharmaceutical tragedies …

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Episode 1: When Mirror Images Mattered: A Historical Prelude to Chiral Drug Regulation

Leave a Comment / Chiral science, Chirality, Regulatory Affairs / By / , / May 7, 2025

“Before the world looked closely at molecular mirror images, the pharmaceutical landscape was filled with blind spots -this is the story of how chirality found its voice.” Introduction The phenomenon of chirality, where molecules exist as non-superimposable mirror images, permeates the natural world. In biological systems, chirality is fundamental: proteins, enzymes, and receptors are inherently stereospecific, responding differently to the two mirror-image forms, or enantiomers, of a compound. In pharmacology, these subtle molecular differences can …

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Chiral Pharmacology: The Mirror Image of Drug Development

Leave a Comment / Chiral Pharmacology, Chiral science / By / , / April 15, 2025

Abstract Chiral pharmacology, which studies how different enantiomers (mirror-image forms of molecules) affect the body, has truly changed the landscape of pharmaceutical science. It highlights the importance of stereochemistry – the three-dimensional structure of molecules – in making drugs safer and more effective. Today, over half of modern medicines are chiral, but in the past, many were given as racemic mixtures (a blend of enantiomers), leading to unpredictable results. This article delves into the fascinating …

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Part 5. The Future of Chirality: Challenges and Innovations

Leave a Comment / Chiral science, Chirality / By / / April 12, 2025

As the study of chirality enters its next phase, it remains at the forefront of scientific exploration, bridging disciplines such as chemistry, biology, pharmacology, and material science. The journey from its foundational discoveries to the transformative breakthroughs in asymmetric synthesis and pharmaceutical applications has established chirality as a fundamental concept in understanding and manipulating molecular asymmetry. This final chapter provides a holistic summary of chirality’s journey, its underpinnings, and where it is headed in the …

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