Manufacturing Small Molecule Drugs and Biologicals

  • J. Rick Turner


As noted in Section 3.2.3, drug discovery/design pays close attention to the pharmacokinetics of a drug candidate. A drug molecule with a good pharmacodynamic profile, i.e., a profile that indicates it would interact successfully with its target receptor, will not be clinically useful if it does not reach the target receptor in the chemical state necessary to affect a response. Therefore, getting the drug to the microenvironment of the target receptor in the necessary chemical state is a key consideration. In addition to pharmacokinetic considerations, pharmaceutical considerations are critical. Successfully producing the drug candidate for nonclinical testing and clinical trials and manufacturing the drug for postapproval marketing are critical. Moreover, their complexity and difficulty should not be underestimated.


Drug Product Drug Candidate Active Pharmaceutical Ingredient Target Receptor Solid Dosage Form 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Further Readings

  1. Gopalaswamy S, Gopalaswamy V, 2008, Combination Products: Regulatory Challenges and Successful Product Development. Boca Raton, FJ: CRC Press.CrossRefGoogle Scholar
  2. Kulshreshtha AK, Singh ON, Wall GM (Eds), 2010, Pharmaceutical Suspensions: From Formulation to Manufacturing. New York, NY: Springer-Verlag.Google Scholar
  3. Niazi SK, 2009, Handbook of Pharmaceutical Manufacturing Formulations. Multi-volume set. New York, NY: Informa Healthcare.Google Scholar
  4. Walsh G, 2007, Pharmaceutical Biotechnology: Concepts and Applications. Chichester, UK: Wiley.Google Scholar
  5. Monkhouse DC, 2006b, Manufacturing and clinical medicine trends for the clinical trials material professional. In Monkhouse DC, Carney CF, Clark JL (Eds), Drug Products for Clinical Trials, 2nd Edition. Boca Raton: Taylor & Francis, 21–68.Google Scholar
  6. Tsong Y, Chen C-W, Chen WJ, et al., 2006, Stability studies of pharmaceuticals. In Buncher CR, Tsay J-Y (Eds), Statistics in the Pharmaceutical Industry, 3rd Edition. Roca Raton: Chapman & Hall/CRC, 391–419.Google Scholar
  7. Brun P, 2006, Blinding of drug products. In Monkhouse DC, Carney CF, Clark JL (Eds), Drug Products for Clinical Trials, 2nd Edition. Boca Raton: Taylor & Francis, 149–172.Google Scholar
  8. Walsh G, 2003, Biopharmaceuticals: Biochemistry and Biotechnology. Chichester, UK: Wiley.Google Scholar

Copyright information

© Springer Science+Business Media, LLC 2011

Authors and Affiliations

  1. 1.Cardiac Safety Services QuintilesDurhamUSA

Personalised recommendations