1.

Record Nr.

UNINA9911019706603321

Titolo

Manual of smoking cessation : a guide for counsellors and practitioners / / Andy McEwen ... [et al.]

Pubbl/distr/stampa

Malden, Mass., : Blackwell Pub. Inc., 2006

ISBN

9786611321178

9781281321176

1281321176

9780470757864

0470757868

9780470757840

0470757841

Descrizione fisica

1 online resource (170 p.)

Altri autori (Persone)

McEwenAndy

Disciplina

616.86/506

Soggetti

Smoking cessation

Cigarette smokers - Rehabilitation

Nicotine addiction - Treatment

Lingua di pubblicazione

Inglese

Formato

Materiale a stampa

Livello bibliografico

Monografia

Note generali

Description based upon print version of record.

Nota di bibliografia

Includes bibliographical references and index.

Nota di contenuto

pt. 1. Essential information -- pt. 2. Practical advice.

Sommario/riassunto

Manual of Smoking Cessation provides the crucial knowledge required if you are involved in helping smokers to stop. The manual provides facts, figures, suggested interventions and sources of further information to assist in providing evidence-based treatment for smokers wishing to stop. This manual covers the core content areas and key learning outcomes described in the Standard for Training in Smoking Cessation (Health Development Agency, 2003). Manual of Smoking Cessation is structured in two concise parts: Part 1 provides essential information on smoking demographics, along with the



2.

Record Nr.

UNINA9910983317403321

Titolo

Dose Finding and Beyond in Biopharmaceutical Development / / edited by Jingjing Ye, Ding-Geng Chen, Wen Zhou, Qiqi Deng, Joseph C. Cappelleri

Pubbl/distr/stampa

Cham : , : Springer Nature Switzerland : , : Imprint : Springer, , 2025

ISBN

9783031671104

3031671104

Edizione

[1st ed. 2025.]

Descrizione fisica

1 online resource (XVII, 254 p. 43 illus.)

Collana

ICSA Book Series in Statistics, , 2199-0999

Disciplina

570.15195

Soggetti

Biometry

Experimental design

Data mining

Biostatistics

Design of Experiments

Data Mining and Knowledge Discovery

Biometria

Disseny d'experiments

Mineria de dades

Llibres electrònics

Lingua di pubblicazione

Inglese

Formato

Materiale a stampa

Livello bibliografico

Monografia

Nota di contenuto

Emerging Topics in Dose-Finding and Beyond -- Understanding FDA Guidance On Dosage Optimization For Oncology Therapies -- FDA Project Optimus: The "Paradigm-Shifting" Initiative for Oncology Drug Development -- Challenges and Practical Guidance on the Implementation of Novel Oncology Dose Escalation Designs -- Challenges and Practical Guidance on the Implementation of Novel Oncology Dose Escalation Designs -- Monotonic Dose Response Assumption and Curve-Free Designs for Phase I Dose Finding Trials -- Dose Selection with 2-in-1 Design -- A Rank-Based Approach to Improve the Efficiency of Inferential Seamless Phase 2/3 Clinical Trials with Dose Optimization -- Comparing MCP-MOD and Ordinal Linear



Contrast Test in Dose Finding Clinical Trials: A Thorough Examination -- Patient-Reported Tolerability in Drug Development -- Endpoint Development and Validation.

Sommario/riassunto

This book covers topics in 2 parts: 1) Review of FDA Guidance, 2) Novel Designs and Analyses. While covering basic principles of dose finding, this book details advancements made in drug development. Finding the right dose(s) is one of the most important objectives in new drug development. In Phase I clinical development, one of the objectives is to escalate test doses from low to high. The low doses should be safe, then escalate up to the maximally tolerable dose (MTD). Phase Ⅱ clinical trials then lower test doses to the minimal efficacious dose (MinED). Dose range of a study drug can be thought of as the doses between MinED and MTD. From this dose range, one or a few doses are selected for Phase Ⅲ confirmation. In practice, dose finding is a very difficult in every phase of clinical development for new drugs. The editors brought distinguished researchers and practitioners in biopharmaceuticals and universities, to discuss the statistical procedures, useful methods, and their novel applications in dose finding. The chapters in the book present emerging topics in dose-finding and related interdisciplinary areas. This timely book is a valuable resource to stimulate the development of this growing and exciting field in drug development. .