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Reportlinker Adds Pharmaceutical Contract Manufacturing: Industry and Market Prospects 2010-2025
Date:10/7/2010

Routine Inspection of Outsourcing Sites

7.6.4 Need for Creation of Economic Zone for Pharmaceutical Industry

7.6.5 India as an Emerging Market

7.6.6 Vertical Integration Recommended for India's Companies

7.6.7 India's Emergence as a Major Pharmaceutical Market

8. Contract Pharma for Specialised Areas

8.1 Value-Added Services and Contract Pharma

8.2 One-Stop Shop (CRO and CMO)?

8.3 Interview with Manish Badonia, Cadila

8.3.1 One-Stop Shop: CROs and CMOs

8.3.2 Value-Added Services in Global Settings

8.4 Interview with Wesley Wheeler, Patheon

8.4.1 Outsourcing for Analytical Testing Services

8.5 CMOs Venture into Development and Product Extensions

8.6 The Use of CROs in Drug Discovery and Development is Increasing in Pharma Industry

8.6.1 Contract Research for Drug Discovery at Suven Life Sciences

8.7 Interview with Dr Debra Sponholtz, Chembiotek

8.7.1 CROs Offer a Full Range of Services

8.8 Outsourcing Electronic Data Management

8.9 Outsourcing of Data Management in India

8.9.1 GlaxoSmithKline to Outsource Data Management

8.9.2 Wyeth (Pfizer): Outsourced Data Management

8.10 Planning Required for Regulatory Affairs Outsourcing

8.11 Outsourcing Bioequivalence Studies for Generic Drugs

8.12 Requesting a Waiver from a Bioequivalence Trial

8.13 Bioequivalence Studies for New Drug Applications

8.14 Interview with Helmut Schutz, BEBAC

8.14.1 When in Vivo Bioequivalent Studies are Waived for ANDA

8.14.2 Success of Outsourcing Dissolution Testing/ Bioequivalence Studies

8.14.3 Success of Off-Shoring in Vivo Bioequivalence Studies to India

8.15 Interview with Dr Daniel Abran, Sandoz

8.15.1 Waivers of in Vivo BE Studies (Biowaivers) for Abbreviated New Drug Applications

8.15.2 Comparative Clinical Trial Requirement for ANDA

8.16 Interview with Manish
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